Patients on supraphysiologic doses of steroids or use of such within the previous six weeks
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Participants are required to be on antiretroviral regimens that are in accordance with the current International Acquired Immune Deficiency Syndrome (AIDS) Society guidelines concurrently with chemotherapy; the specific agents are at the discretion of the investigator and the use of investigational agents currently available on an expanded access basis is allowed; use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir or Kaletra), cobicistat, didanosine (Videx or Videx EC), or similar potent cytochrome P450 (CYP)3 inhibitors are prohibited; in order to be eligible, participants taking zidovudine or ritonavir, or cobicistat, didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation; changes to HAART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.); participants must be on HAART at least 7 days prior to therapy
Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, cannabis, S. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto or ginseng)\r\n* Raloxifene is allowed for patients taking it for bone health
No intent to use myeloablative conditioning regimens.
Current use of natural herb products or other complementary alternative medications; if used previously, patients must have at least 1-week washout and must stop using them while participating in this study
Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs
Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days prior to study entry and throughout the study period; participants will be encouraged to use acetaminophen for minor pain and fever
STEP I: Prior systemic glucocorticoid use for the treatment of non-malignant disorders is permitted; prior or concurrent topical or localized glucocorticoid therapy to treat non-malignant comorbid disorders is permitted
Patients must also be offered participation in banking for future use of specimens
Patients must have no known allergies to exemestane, entinostat, or medications that have a benzamide structure (e.g., tiapride, remoxipride, clebropride)
Patients CANNOT have daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
CYTOCHROME P450 3A4 (CYP3A4) substrates WITH narrow therapeutic indices: patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; Note: the use of fentanyl is permitted
Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
Prior bisphosphonate use is permitted
History of erythema nodosum if characterized by a desquamating rash while taking thalidomide, pomalidomide, or similar drugs
Patients must not currently be receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior); all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4
If medically feasible, patients taking regular medication, with the exception of potent inducers of CYP3A4, should be maintained on it throughout the study period; patients taking concomitant medications whose disposition is dependent upon breast cancer resistance protein (BCRP) and which have a narrow therapeutic index should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving osimertinib\r\nNOTE: Use of St John’s wort is a contra-indication for osimertinib use
Supportive care and other medications that are considered necessary for the subject’s wellbeing may be given at the discretion of the investigator
A guidance regarding potential interactions with concomitant medications is provided
A medical condition requiring use of proton pump inhibitors (PPIs); or histamine 2 (H2) receptor antagonists; patients who intermittently use these medications, must meet the following criteria:\r\n* No use of PPIs within 5 days before the first dose of alisertib\r\n* No use of H2 antagonist or pancreatic enzymes within 24 hours before the first dose of alisertib
Use of any prohibited concomitant medications: immunotherapy, 5 alpha reductase inhibitors, spironolactone, diethystilbestrol (DES), ketoconazole, newer medications targeting ARs; NOTE: the concurrent use of all other drugs, over-the-counter medications, or alternative therapies must be documented; the principal investigator should be alerted if the patient is taking any agent that interacts with CYP450 system
Patients who need to continue treatment with any prohibited medications
Patients who have not completed the appropriate washout period for the prohibited medications
Use of any vaccines against infectious diseases (e.g. influenza, varicella, pneumococcus) within 4 weeks of initiation of study treatment.
Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy
Intake of any herbal preparations or medications (including, but not limited to, Saint John’s wort and ginkgo biloba) and dietary supplements within 7 days prior to first dose of study drug
Current use of a prohibited medication
Able to understand and adhere to dietary and medication restrictions as recommended for the safe use of phenelzine
Concurrent use of medications contra-indicated due to potential interactions with phenelzine
Inability to comply with dietary restrictions for foods, supplements, and medications with potential for adverse interactions with phenelzine or to otherwise cooperate fully with the investigator and study personnel
Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
The eligibility of patients receiving any medications or substances known or with potential to affect the activity or pharmacokinetics of temozolomide and/or pazopanib will be determined following review of the case by the Principal Investigator; efforts should be made to switch patients who are taking enzyme-inducing agents to other medications
Use of any prohibited medication within the timeframes
Concomitant use of any enzyme inducing anticonvulsants is not allowed
Need for > 2 antihypertensive medications for management of hypertension (including diuretics).
Is able to take medications orally (e.g., no feeding tube).
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to enrollment:\r\n* Known strong and moderate inducers or inhibitors of CYP3A4/5, including enzyme inducing anti-convulsant drugs (EIACDs), grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\r\n* Substrates of CYP3A4/5 with a narrow therapeutic index\r\n* Herbal preparations/medications (except for vitamins) including, but not limited to: St. John’s wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng; patients should stop using all herbal medications and dietary supplements at least 7 days prior to enrollment
Herbal preparations/medications are not allowed throughout the study
Currently taking 3 or more anti-hypertensive medications
Receiving any medications or substances with risk of Torsades de Pointes; Note: medications or substances on the list “Drugs with Risk of Torsades de Pointes” are prohibited; medications or substances on the list “Drugs with Possible or Conditional Risk of Torsades de Pointes” may be used while on study with extreme caution and careful monitoring
Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy;
Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated washout period:
Anticipated use of any concomitant medication during or within 7 days before initiation of study treatment that is known to cause QT prolongation
Requirement for concomitant therapy or food that is prohibited during the study
Participants receiving any medications or substances that are moderate and/or potent enzyme inducers or inhibitors which may have an effect on the metabolism of bavituximab; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients currently receiving aspirin, and/or ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs) are not eligible
Concurrent use or anticipated need for medications that are mainly metabolized by UGT1A9 including their administration within 7-days prior to the first dose of study drug (e.g., raloxifene, valproic acid, propofol, propranolol, dapagliflozin, darexaban, mycophenolic acid, and tapentadol)
Acetaminophen use within 24 hours before a dose of gedatolisib (PF-05212384)
Concurrent use of herbal preparations including saw palmetto
Current use of drugs that are known to prolong QT interval
Chronic use of moderate or strong CYP3A4 modulators (inhibitor or inducer) or any other prohibited medications. A washout period of 7 days is required prior to venetoclax dosing if a prohibited medication is discontinued.
Chronic use of a P-gp inhibitor, or a P-gp substrate with a narrow therapeutic index. A washout period of 7 days is required prior to venetoclax dosing if a prohibited medication is discontinued.
Currently taking a prohibited concomitant medication, other than a premedication, that are/is:
Require therapeutic use of anticoagulants
Participants receiving any medications or substances that are known to cause photosensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones, St. Johns' wort, amiodarone) are ineligible.
Required use of medications predominantly cleared by hepatobiliary transporters within 48 hours of study drug infusion
Have used or plan to use from 30 days prior to enrollment through the end of the study medication known to lower the seizure threshold or prolong the QT interval
Prior use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, carboplatin, or radium-223 for the treatment of castration-resistant disease\r\n* Prior docetaxel use in the hormone-sensitive disease setting is allowed, but must be completed >= 4 weeks prior to enrollment\r\n* Prior sipuleucel-T use is allowed, but must be completed >= 4 weeks prior to enrollment\r\n* Concurrent use of zolendronic acid or denosumab is allowed on study
Current use of drugs that are known to prolong the QT interval
Inability to lie flat and still for treatment delivery despite anti-anxiety and/or pain medications
Inclusion Criteria:\n\n        • Patients aged 65 to < 75 years with at least one non severe comorbidity ie disease or\n        syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities\n        which could increase the risk of toxicity and/or early death of intensive chemotherapy in\n        the opinion of the investigator and are not contra-indicated for non-intensive\n        chemotherapy.\n\n        or ? 75 years with or without any comorbidity at the time of the informed consent\n        signature;\n\n        • Newly diagnosed, untreated de novo or secondary AML according to WHO classification;\n\n        Exclusion Criteria:\n\n          -  Prior or current treatment with chemotherapy for any myeloid disorder (excluding\n             hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of\n             randomization;\n\n          -  Prior treatment with decitabine, azacitidine, or cytarabine;\n\n          -  Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma\n             of the skin, or carcinoma \ in situ \ of the cervix or breast;\n\n          -  Chronic myelogenous or acute promyelocytic leukaemia;\n\n          -  Known CNS involvement;\n\n          -  Patient eligible to bone marrow or stem cell transplant;\n\n          -  WBC ? 30.000/mm3;\n\n          -  Impaired renal function with Creatinine clearance < 30 mL/min/1.73m² according to the\n             MDRD formula;\n\n          -  Serum bilirubin ? 2.5 x ULN and/or AST and/or ALT ? 2.5 x ULN (upper limit of normal\n             value);\n\n          -  Calcemia ? 2.65 mmol/L (106 mg/L) at screening assessment (corrected with\n             albuminemia);\n\n          -  History of diseases known to be associated with calcium disorders: ongoing\n             hyperparathyroidism, sarcoidosis….;\n\n          -  Presence or history of symptomatic kidney stones in the last 5 years;\n\n          -  Hypersensitivity to any of the excipients of decitabine (Potassium dihydrogen\n             phosphate (E340) ; Sodium hydroxide (E524) ; Hydrochloric acid (for pH adjustment) or\n             to the excipient of inecalcitol tablets (lactose);\n\n          -  Current use of drugs known to influence serum calcium (such as thiazide diuretics,\n             teriparatide, calcitonin and multivitamin supplements containing > 400 IU of vitamin D\n             or calcium);\n\n          -  Current use of digitalis;\n\n          -  Current use of drugs which could influence bioavailability of inecalcitol (such as\n             magnesium-containing antacids, bile-resin binders);\n\n          -  Use of any other experimental drug or therapy or vitamin D supplementation within 4\n             weeks of randomization;\n\n          -  Known HIV;\n\n          -  Patients who are eligible for intensive induction therapy with curative intent;\n\n          -  Refractory congestive heart failure;\n\n          -  Active infection resistant to anti-infective therapy;\n\n          -  Documented pulmonary disease with DLCO ? 65% or FEV1? 65%, or dyspnea at rest or\n             requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm;\n\n          -  Liver cirrhosis Child B or C or acute viral hepatitis;\n\n          -  Current mental illness requiring psychiatric hospitalization, institutionalization or\n             intensive outpatient management, or current cognitive status that produces dependence\n             (as confirmed by the specialist) not controlled by the caregiver;\n\n          -  Uncontrolled neoplasia;
Patients receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
Subject is willing and able to use the technological aspects of the trial.
Use of T cell depletion either ex vivo or in vivo (i.e. ATG, alemtuzumab) is prohibited.
Prior use of regorafenib
Patients with concomitant use of drugs, herbal supplements and/or ingestion of foods known to modulate cytochrome P450 family 3 subfamily A member 4 (CYP3A4) enzyme activity as specified in the drug specific appendix
Subjects requiring daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days prior to study registration
The use of cannabis oil is prohibited during the first 2 cycles of this protocol; patients must be off of cannabis oil for 3 days prior to enrollment
Sexually active males must use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid; fertile males must use a condom with spermicide (double barrier method)
Patients who have any prior chemoimmunotherapy are not eligible; NOTE: the use of steroids to control the disease is permitted and does not have a washout period
Participants taking medications that are known to be associated with torsades de pointes or QT prolongation within 14 days of starting treatment
Participants cannot take any herbal preparations/medications on study or within 7 days prior to first dose of study drug, including but not limited to: St. John‘s wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng
Use of salicylates, non-steroidal anti-inflammatory drugs, or sulfonamide medications within one week of start of methotrexate
medications belonging to the class of sulfonamides, with the exception of sulfanilamides (e.g., sulfamethoxazole).
Current use of a prohibited medication as described
A list of prohibited medications on study are listed
Concomitant use of drugs that may cause significant QT prolongation and/or torsades de pointes that cannot be discontinued or switched to a different medication prior to treatment
Patients who are unwilling to stop the use of herbal remedies while receiving study treatment
Prior use of natalizumab for any reason is not allowed
Must use a condom if having sex with a pregnant woman
The following concomitant medications are not allowed during navitoclax administration: clopidogrel, ibuprofen, tirofiban, warfarin, and other anticoagulants, drugs, or herbal supplements that affect platelet function are excluded, with the exception of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\n* Anticoagulants or antiplatelet agents except for low-dose, 81 mg aspirin
Use of corticosteroids (glucocorticoids) within 21 days of the MILs collection
Taking medications that are known to be associated with torsades de pointes; medications include but are not limited to:\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycins, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic\r\n* Chloroquine, domperidone, halofantrine, levomethadyl, pentamidine\r\n* Sparfloxacin, lidoflazine\r\n** Note: participants who have taken a medication associated with torsades de pointes will still be eligible for participation if the medication is discontinued at least 14 days before the initiation of study treatment
>= 4 weeks from protocol tissue procurement since resolution of all immune related toxicities and off systemic steroids >= 4 weeks; prophylactic use of steroids in preparation for radiologic exams are acceptable
Participants taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate, sulfasalazine and nonsteroidal anti-inflammatory agents) will also be excluded, unless otherwise approved by the principal investigator or PI’s designee
Concomitant use of the following drugs: antioxidants; herbal or other alternative therapy medications; vitamin supplements (especially vitamins A, C, and E) other than a standard dose multivitamin, acetaminophen, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, ceftriaxone, and amiodarone; if the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study after a washout period of four half-lives
Exposure to any prior chemotherapy, steroid use, or other myeloma treatment within 14 days prior to first dose. Pts currently on long term steroids do not require any washout period. in addition, steroid use for spinal cord compression is permitted and does not require a washout period.
Concomitant medication restrictions:
Concomitant medication restrictions
Patients may not be taking enzyme–inducing anticonvulsants, and may not have received these medications within 1 week prior to study enrollment, as these patients may experience different drug disposition; these medications include: Carbamazepine (Tegretol), Felbamate (Felbtol), Phenobarbitol,  Phenytoin (Dilantin),  Primidone (Mysoline), Oxcarbazepine (Trileptal)
Use of red blood cell or platelet transfusions within 4 weeks of treatment
Male participants whose partners are pregnant should use condoms for the duration of the pregnancy
Current use, or up to 14 days prior use, of certain prohibited medication or requires any of these medications during treatment phase.
Require continued treatment with medications that are known to carry a risk of torsades de pointes.
Use of a sustained release opioid medication such as long-acting morphine, fentanyl patches, methadone, and buprenorphine within the last 3 months
Current treatment with medications that are well known to prolong the QT interval
Receipt of anticancer medications or investigational drugs within Protocol-defined time frames.
Use hormone replacement therapy (including systemic or topical estrogen, progesterone, or testosterone based medication) or/and phytoestrogen supplements (i.e. black cohosh) or has been on progestin (including progestin containing IUD), tamoxifen or aromatase inhibitor within the prior 3 months
Have a peripheral blast count of >30,000/mm3 (may use hydroxyurea as in #3 above)
Need for > 2 antihypertensive medications for management of hypertension (including diuretics).
Medications that have a known risk to prolong the QT interval or induce Torsades de Pointes;
Herbal preparations/medications. These herbal medications include, but are not limited to: St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.
With the exception of low-dose aspirin, subjects enrolled in this study should not take concomitant medications that durably inhibit platelet function including marine oil tablets; for such medications a wash-out period of >= 7 days is required prior to starting treatment; agents which inhibit platelet function transiently or inhibit coagulation by other mechanisms are restricted (e.g. use with caution); medications that directly and durably inhibit platelet function include aspirin containing combinations, clopidogrel, dipyridamole, tirofiban, epoprostenol, eptifibatide, cilostazol, abciximab, ticlopidine, cilostazol
Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal antiinflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
Requiring treatment with any of the prohibited concomitant medications listed that cannot be stopped for the duration of trial participation
Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib.
Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib.
Current use of a prohibited medication while on dabrafenib/trametinib
Concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided; medications that enhance glucuronidation (i.e. phenytoin, phenobarbital, carbamazepine, rifampin, etc.) should be avoided; it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients should avoid concomitant medication known or suspected to prolong QTc interval or cause Torsades De Pointes; if possible, alternative agents should be considered; patients who are receiving drugs that prolong the QTc are eligible if the drug is necessary and no alternatives are available
Herbal preparations are not allowed throughout the study; these herbal medications include but are not limited to: St. John's wort, kava, ephedra (ma hung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng; patients should stop using these herbal medications 7 days prior to study enrollment
Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of < 12 months prior to Cycle 1 Day 1 (if applicable), and have a confirmed diagnosis of steroid-refractory cGvHD defined per 2014 NIH consensus criteria irrespective of the concomitant use of a calcineurin inhibitor (CNI), as follows:
Use of other prohibited medications within 7 days prior to cycle 1 day 1 on study (Arms B and C only) (see Appendix 1 for list of prohibited medications)
Required use of a concomitant medication that can prolong the QT interval
Use of opioid medications for cancer-related pain, including codeine and dextropropoxyphene, currently or any time within 4 weeks of Day 1, Cycle 1
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of the study drugs.
Patients may not be receiving any other investigational agent for any purpose concurrently; patients may not require ongoing treatment with (a) gastric pH modifying medications including proton pump inhibitors or H2 blockers (patients may switch to antacids), (b) medications which are known to be sensitive substrates or substrates with a narrow therapeutic index for the P-gp and BCRP transporters and/or (c) medications known to cause corrected QT (QTc) prolongation with risk of Torsades
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Use of any of the following concurrent treatment or medications:\r\n* Radiation therapy\r\n* Chemotherapy\r\n* Interferon (e.g. Intron­A)\r\n* Allergy desensitization injections\r\n* Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n* Interleukins (e.g. Proleukin)\r\n* Any investigational therapeutic medication
Known life-threatening reaction (i.e., anaphylaxis) to Thymoglobulin® that would prohibit use for the patient as this study requires use of the Thymoglobulin® preparation of ATG.
Patients requiring prolonged treatment with fluconazole, voriconazole, or posaconazole; use of isavuconazonium sulfate, liposomal amphotericin, are echinocandins are permitted
Patients are ineligible if they plan on regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required
Participants must agree to discontinue all vitamin supplements while taking study medication and for thirty days past the last dose of study medication
Have not used exogenous hormone replacement therapy or oral contraception in the year prior to diagnosis; the use of non-systemic estrogen (such as vaginal estrogen use) is allowed
Is currently taking any prohibited medication(s).
No history of long-term use of corticosteroids or concurrent short term use of corticosteroids is allowed
Herbal preparations/medications are not allowed throughout the study, including but not limited to St. John's Wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng. Patients should stop using these herbal medications 7 days prior to the first dose of AZD4635.
Concomitant medications with another A1R antagonist that would increase the risk of seizure (e.g., theophylline, aminophylline).
Ongoing corticosteroid use.
Currently receiving treatment with any other agent listed on the prohibited medication list
?7 days for immune-suppressive-based treatment for any reason. Note: Use of inhaled or topical corticosteroid use for radiographic procedures is permitted. Note: The use of physiologic corticosteroid replacement therapy may be approved after consultation with the sponsor.
Patients who are currently receiving medication with a known risk of prolonging the QT interval inducing torsades de pointes (TdP) and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment; a list of prohibited drugs with a known risk of TdP is provided
Taking cimetidine or allopurinol; if currently taking either of these medications, patient must discontinue for one week before receiving treatment with nab-paclitaxel
Prior use of bevacizumab
Use of any of the following concurrent treatment or medications:\r\n* Radiation therapy\r\n* Chemotherapy\r\n* Interferon (e.g. Intron-A)\r\n* Allergy desensitization injections\r\n* Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n* Interleukins (e.g. Proleukin)\r\n* Any investigational therapeutic medication
Requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation
Asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
Use of opioid analgesics for cancer-related pain
Prior use of regorafenib
Use of antidepressants such as sertraline within 6 weeks OR use of paroxetine, fluoxetine, or citalopram within 3 months prior to registration
AIDS defined as a CD4 (cluster of differentiation 4) count less then 200 in the context of HIV sero-positivity or chronically is taking immunosuppressive medication such as steroids or transplant related medications.
While not an exclusion criterion, unless clinically indicated, patients should avoid taking other additional non-study medications that may interfere with the study medications; in particular, patients should avoid medications that are known to either induce or inhibit the activity of hepatic microsomal isoenzymes CYP1A2, CYP2C19 and CYP3A4
No alternative medications or nutraceuticals known to alter PSA (e.g. phytoestrogens and saw palmetto); Note: patients receiving medications for urinary symptoms such as Flomax or 5-alpha reductase inhibitors (finasteride and dutasteride) on a chronic stable dose for at least 3 months prior to study enrollment are allowed
Active viral infection requiring treatment with anti-viral medication (uncomplicated cytomegalovirus [CMV] viremia that is responding to antiviral medications is allowed)
Patients must be willing to use brief courses (at least 72 hours) of steroids as directed for potential inflammatory side effects of the therapy if recommended by their treating physician
Patients with uncontrolled seizures defined as seizures that require regular use of rescue medications or in the opinion of the investigator require increasing doses of anti-epileptic medications or would compromise the ability to tolerate study therapy or interfere with protocol therapy or procedures; patients with seizures that are well controlled are eligible and may be on antiepileptic medications if on a stable dose
EXCLUSION CRITERIA FOR STRATUM C: Patients with uncontrolled seizures defined as seizures that require regular use of rescue medications or in the opinion of the investigator require increasing doses of antiepileptic medications or would compromise the ability to tolerate study therapy or interfere with protocol therapy or procedures; patients with seizures that are well controlled are eligible and may be on antiepileptic medications if on a stable dose
The development of erythema nodosum as characterized by desquamating rash while taking thalidomide or similar drugs
Prior use of ibrutinib
Require therapeutic use of anticoagulation medications
No prior anti-leukemic therapy except the following are allowed: < 1 week of corticosteroids, or hydroxyurea or emergent leukapheresis; longer steroid use for diseases other than leukemia is permitted
Donors who fail eligibility requirements for donation of cells or tissue for donation of a Human Cell and Tissue Products (HCT/P) will be excluded unless use of the cells complies urgent medical need or allogeneic use in a first-degree or second-degree relative
The use of raloxifene, denosumab, or bisphosphonates for bone health is allowed
Patients must be at least 1 week from the last dose of complementary or alternative medications
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for the care of the patient.
Concomitant systemic treatment with chronic use (based on the investigator’s judgment) of corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs, and other platelet inhibitory agents
Currently using or planning to use:
Currently receiving any prohibited medications including vitamins and herbal supplements
Use of a prohibited concomitant medication that cannot be safely discontinued or substituted.
Current use of a prohibited medication or requires any of these medications during treatment with the investigational drugs. This includes excluding current medications known or suspected to be associated QT prolongation. In addition, any subject who is expected to require a QT prolonging medication while on trial should not be enrolled.
Patients taking drugs leading to significant QT prolongation and unable to stop drugs prior to treatment
Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of AZD1775 will be determined following review by the principal investigator
Use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study.
Unable to discontinue the use of prohibited medications
Use of corticosteroids or other immunosuppression (if patient had been taking steroids, at least 2 weeks must have passed since the last dose)
For brachytherapy, an IPSS ? 21, or ? 17 if patient is on medications to improve urination.
Concomitant medications: drugs that are considered category D (consider therapy modification) and X (avoid combination) using the Lexicomp database are prohibited; concomitant drugs that fall into categories A (no known interaction), B (no action needed) and C (monitor therapy) are allowed
Presence of another malignancy requiring current treatment that would preclude the use of all of the study treatments or the ability to monitor the natural history of MCD untreated
Known prior development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Concomitant receipt of the following sensitive CYP substrate medications that have a narrow therapeutic range (unless the participant can be transferred to other medications at least 5 half-lives prior to the start of study treatment): paclitaxel and docetaxel (CYP2C8), phenytoin (CYP2C9), S-mephenytoin (CYP2C19), thioridazine (CYP2D6), theophylline, and tizanidine (CYP1A2)
Nonsteroidal anti-inflammatory drugs (NSAIDs), intravenous (IV) contrast, aminoglycosides, or other potentially nephrotoxic drugs within 2 weeks of enrollment
Current use of a non-standard dialysis membrane
Current use of a smoking cessation medication (e.g. nicotine replacement, varenicline, bupropion)
Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco)
Active alcohol use disorder or hazardous drinking; this will be screened with the Alcohol Use Disorders Identification Test (AUDIT-C), and positive scores (4 or greater for men and 3 or greater for women) will result in study clinician assessment and discretion
Specific medications
The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled central nervous system (CNS) leukemia. (2) use of hydroxyurea and/or one dose of cytarabine (up to 2 g/m^2) or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.
Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors, including their administration within 10 days prior to patient treatment with study drug (eg, grapefruit juice or grapefruit/grapefruit-related citrus fruits [eg, Seville oranges, pomelos], ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, erythromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan); the topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed
The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted.
Current anticoagulant or antiplatelet aggregation therapy except for aspirin or non-steroidal anti-inflammatory drugs
Current or recent (within 10 days of study enrollment) use of anticoagulants that, in the opinion of the investigator, would place the subject at significant risk for bleeding. Prophylactic use of anticoagulants is allowed.
Current treatment with medications that are well known to prolong the Q-wave/T-wave (QT) interval
Requirement for diuretics, paracentesis, or other medications or procedures to control ascites or hepatic encephalopathy within 6 months before enrollment\r\n* Diuretics or medications such as lactulose used for other indications (e.g. edema, constipation) are allowed
Use of any prohibited concomitant medications within 14 days prior to treatment start, or use of prohibited concomitant medications within the outlined windows\r\n* Note: Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to treatment start
STRATUM A: Participants must discontinue herbal preparations, herbal medication, and dietary supplements, with the exception of multivitamins, at least 7 days prior to study enrollment
STRATUM B: Participants must discontinue herbal preparations, herbal medication, and dietary supplements, with the exception of multivitamins, at least 7 days prior to study enrollment
STRATUM C: Participants must discontinue herbal preparations, herbal medication, and dietary supplements, with the exception of multivitamins, at least 7 days prior to study enrollment
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug.
Willingness to discontinue medications known to be associated with risk of Torsades de Pointes such as quinidine, procainamide, disopyramide, amiodarone, erythromycin, clarithromycin, chlorpromazine and haloperidol
Use of a drug known to prolong the cardiac QT interval.
Patients taking medications that have the potential to prolong the QT interval
Active illicit drug use or diagnosis of alcoholism.
Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4
Subjects taking prohibited medications with the exception of systemic corticosteroids. A washout period of at least 5 elimination half-lives (or as clinically indicated) should occur for prohibited medications prior to the start of treatment
Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required
Patient must discontinue any and all use of multivitamin and/or vitamin c medication 24 hours before first dose of ascorbic acid
Uncontrolled glaucoma (topical medications allowed)
Meet any criteria necessary for the safe and proper use of the induction and consolidation agents involved in this trial
Taking medications with narrow therapeutic windows, unless they can be transferred to other medications prior to enrolling or unless the medications can be properly monitored during the study
Taking P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) or OATP1B1/1B3 transporter-sensitive substrate medications unless they can be transferred to alternative medications within ?5 half-lives prior to administration of AG-221, or unless the medications can be adequately monitored during the study. There are no restrictions regarding the co-administration of such medications with AG-120.
Taking medications that are known to prolong the QT interval unless they can be transferred to other medications within ?5 half-lives prior to dosing (If equivalent medication is not available QTc will be closely monitored)
Prior medication:
Use of alternative medications (e.g., herbal or botanical that could interfere with clofarabine) is not permitted during the entire study period
Daily use of oxygen supplementation.
Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs
Ongoing use of anticoagulant therapy other than aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) that places the participant at increased bleeding risk in the opinion of the site investigator
Required use of a concomitant medication that can prolong the QT interval
Have used or plan to use from 30 days prior to enrollment (day 1 visit) through the end of the study the following medications known to lower the seizure threshold: \r\n* Aminophylline/theophylline\r\n* Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone)\r\n* Bupropion\r\n* Insulin\r\n* Lithium\r\n* Pethidine\r\n* Phenothiazine antipsychotics (e.g., prochlorperazine [compazine], chlorpromazine, mesoridazine, thioridazine)\r\n* Tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
Regular use of immunosuppressant drugs such as steroids (> 15 mg prednisone equivalents), azathioprine, tacrolimus, cyclosporine, etc; use is not permitted within 4 weeks before recruitment
While receiving chemotherapy, the patient must use a condom if having sex with a pregnant woman
Concomitant use of high dose systemic steroids and other drugs such as calcitonin preparations, active vitamin D3 preparations, estrogen preparations, selective estrogen receptor modulators, vitamin K2 preparations, parathyroid hormones, phosphorus absorbers; Note, inhaled, topical steroids and low tapering doses of steroid especially in patients treated recently for brain metastases will be included
Medical history that includes any condition, or requires the use of concomitant medications which, in the investigator's judgment, are associated with or create a risk of increased carotid sinus sensitivity, symptomatic bradycardia, or syncopal episodes.
Receiving or anticipated to receive medications prohibited in the protocol.
Willing to discontinue or not initiate the use of prophylactic hemin throughout the study.
Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
Use of non-steroidal antiandrogens (e.g., flutamide, nilutamide, or bicalutamide) within 6 weeks of registration
Coagulopathy, including the use of therapeutic anticoagulants that cannot be discontinued for the cryoablation procedure; NOTE: Heparin for line patency without detectable lab abnormalities for coagulation will be allowed
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
Medical conditions that preclude the use of general anesthesia;
Multiple immune suppressive medications are routinely used in patients after HCT with cGVHD and will be allowed to continue while participating in this study; these concomitant medications include but are not limited to: tacrolimus, sirolimus, ibrutinib, corticosteroids, mycophenolate mofetil, ruxolitinib, vismodegib, cyclosporine, montelukast, azithromycin, corticosteroids inhalers including those with a long acting beta-agonist (e.g., salmeterol); additional medications and therapies (e.g., extracorporeal photophoresis) for the intentional treatment of BOS will be permitted at the discretion of the provider; prophylactic antimicrobials including trimethoprim/sulfamethoxazole, azole class of antifungals, and acyclovir will also be allowed
Participants that cannot take alternate medications will be excluded from this study
Must use a condom if having sex with a pregnant woman
Patients with viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use are ineligible
Patients must be able to take medications orally (i.e. no feeding tube)
Active illicit drug use or diagnosis of alcoholism
Patients receiving medications that are known to be substrates of CYP2C8 (including paclitaxel), CYP2C9, or CYP2C19 or to be oral substrates of CYP3A with narrow therapeutic window; subjects who have discontinued any of these medications must have a wash-out period of at least 5 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of merestinib
Prior use of clofarabine or fludarabine
Written authorization for use and release of health and research study information has been obtained.
Current use of a prohibited medication. The following medications or non-drug therapies are prohibited\r\n* Other anti-cancer therapy while on study treatment. (note: megestrol [Megace] if used as an appetite stimulant is allowed).\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy. Prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis.\r\n* Because the composition, PK, and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng).\r\n* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible. Current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded.
Patients receiving prohibited medications; prohibited medications or those to be used with caution (i.e., ketoconazole, itraconazole, ritonavir, macrolide antibiotics, erythromycin phenytoin, phenobarbital, carbamazapine, and valproic acid)
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes (unless these can be changed to acceptable alternatives).
Current or previous use of a prohibited medication as listed in the protocol;
Taking medications with risk of prolonging the QT interval or inducing torsade de pointes, if such treatment cannot be discontinued or switched to a safe alternative medication prior to starting treatment
Patients taking medications with a narrow therapeutic index including warfarin, digoxin, phenobarbital, carbamazepine, and cyclosporine are not excluded but should be monitored carefully.
Co-morbidities that would influence wound healing including diabetes (insulin dependent) or smoking (current ongoing use)
Use of OsteoCool in vertebral body levels C1-C7
Concomitant Medications:
Current use of any of the prohibited drugs
Patients, who require urgent initiation of chemotherapy (other than debulking agent such as hydroxyurea or cyclophosphamide) due to leukemia-related emergencies such as leukostasis, or disseminated intravascular coagulopathy; patients will not be excluded solely based on prior use of debulking agent; prior or current use of leukapheresis will be allowed
Any other condition that may not allow safe use of chemotherapy based on the clinical judgment of the treating oncologist
Contra indication or intolerance to required supportive care medications (aspirin and acyclovir)
Use of myeloablative conditioning regimen
Use of parenteral (IV or intramuscular [IM]) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 14 days prior to planned start of therapy
The use of seizure prophylaxis is allowed as long as patients are taking non-enzyme inducing anti-epileptic drugs (non-EIAED); if patients were previously on EIAEDs and these have been discontinued, they must have been discontinued for at least 2 weeks prior to treatment start; if patients require an anti-epileptic medication, then a CYP3A4 non-EIAED can be used such as levetiracetam, valproic acid, gabapentin, topiramate or lacosamide
Subjects taking prohibited medications; a washout period of prohibited medications for a period of at least two weeks or as clinically indicated should occur prior to the start of treatment
Current use or anticipated inability to avoid use of drugs that are known strong CYP3A4/5 inhibitors (atazanavir, boceprevir, conivaptan, clarithromycin, grapefruit or grapefruit juice, indinavir, itraconazole, ketoconazole, nelfinavir, nefazodone, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole)
(Bevacizumab-related exclusion) Current or recent (within 10 days of study enrolment) use of aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or current or recent (within 10 days prior to first dose of bevacizumab) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes Note: The use of full-dose oral or parenteral anticoagulants is NOT permitted for at least two weeks at the time of study enrollment. Prophylactic use of anticoagulants is NOT allowed
Use of concomitant medications with high risk of causing Torsades des Pointes.
Use of immune suppressive agents within 30 days
Have contraindications to the use of pressor agents (e.g., SC epinephrine), notably monoamine oxidase inhibitor (MAOI) use.
Concomitant medications, any of the following should be considered for exclusion: strong CYP3A4 inhibitors: (Patients must discontinue drug 7 days prior to starting ruxolitinib), including but not limited to boceprevir, clarithromycin, conivaptam, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole; in addition, patients will be instructed to avoid grapefruit or grapefruit juice, starfruit, or Seville oranges
Use of two forms of contraception with less than a 5% failure rate or abstinence by all transplanted patients for a minimum of 1 month after the last dose of Idelalisib; for the first 60 days post?transplant, transplant recipients should be encouraged to use non?hormonal contraceptives due to the potential adverse effect of hormones on bone marrow engraftment
Participants are not permitted to receive enzyme inducing anti-epileptic drugs
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes (unless these can be changed to acceptable alternatives).
Current or recent (within 10 days of study enrolment) use of aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or current or recent (within 10 days prior to first dose of bevacizumab) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes\r\n* NOTE: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard of the institution) and the subject has been on a stable dose of anticoagulants for at least two weeks at the time of study enrollment; prophylactic use of anticoagulants is allowed
Receiving QT-prolonging drugs with a risk of causing torsades de pointes (See Appendix E), unless ECG meets inclusion criteria on a stable dose of the drug and with discussion and agreement with the project clinician
Current (within 1 week of Screening) or regular use of any medication (including over-the-counter (OTC), herbal or homeopathic preparations) that could improve or worsen the cancer being studied, or could affect the action or disposition of IT-141, or its clinical or laboratory assessment; e.g. Coumadin therapy, due to high competitive protein binding. Subjects taking ANY supplemental IRON, i.e., therapeutic or as part of a multivitamin regimen, are excluded from this study, whether prescribed or self-medicated.
Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral
Current use of a prohibited medication
Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication.
Subjects taking herbal supplements (St. John's Wort, gingko biloba, etc.) should discontinue these supplements 14 days prior to study registration.
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Concomitant use of other cytotoxic or cytostatic drugs other than PTX
Require intermittent or chronic treatment with an intravenous or oral antiherpetic drug (e.g., acyclovir), other than intermittent topical use
Use of prohibited medications that cannot be changed to an alternative therapy
Patients who are currently taking any medications for systemic anticoagulation other than aspirin will not be eligible
Use of any prohibited concomitant medications within the prior 2 weeks
Patients who are unable to discontinue medications known to affect MIBG uptake (unless approved by the principal investigator [P.I.] or designee)
Patients who occasionally or regularly use medications that impact dopamine receptor signaling and can cause side effects in people with neuroendocrine tumors including PC-PG such as metoclopromide, chloropromazine, prochlorperazine, droperidol, ephedrine, pseudoephedrine, fenfluramine, methylphenidate, phentermine, amitryptaline, imipramine, tranciproamine, moclobemide, phenelzine, paroexetine, and fluoxetine
Current or recent (=< 10 days of study enrollment) use of aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), or therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes\r\n* The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to medical standard of the institution) and the patient has been on a stable dose of anticoagulants for at least 2 week at the time of study enrollment; prophylactic use of anticoagulants is allowed
Use of any prohibited concomitant medications within 7 days of registration
Concomitant medications: the following medicines should be avoided on this study:\r\n* Inhibitors: ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir\r\n* Inducers: rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine\r\n* Patients receiving any of the above medications are ineligible
Uncontrolled glaucoma (topical medications allowed)
No studies have been performed to assess potential metabolic and transport interactions of TRC102; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the case report form must capture the concurrent use of all other drugs, over-the-counter medications, or alternative therapies
Current use of natural herbal products or other complementary alternative medications (CAM) or “folk remedies”
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., interleukin 2, interferon alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to study entry\r\n* NOTE: recent or current use of inhaled steroids is not exclusionary; if subjects are prescribed a brief course of oral corticosteroids, the use should be limited to less than 7 days; isolated use of steroids as premedication for medical procedures to minimize allergic reaction e.g. CT scan dye are allowed
Requires use of therapeutic anticoagulation prior to registration\r\n* NOTE: thromboprophylaxis with any agent is permitted
Concurrent therapy with medications known to prolong the QT interval and/or associated with Torsade de Pointes arrhythmia
Caution should be taken with the use of hydroxychloroquine and any drugs known to interact with it; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients that are on enzyme-inducing anti-epileptic medications
To not obscure cortisol assessment, regular smokers per self report (daily use) will be excluded
Current use of warfarin for any reason; NOTE: if patient can be safely transitioned to another anticoagulant, they may be eligible provided other criteria are satisfied
Receiving any medications or substances with risk of torsades de pointes; NOTE: medications or substances with known risk of torsades de pointes are prohibited; consult pharmacist for review if needed
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of ibrutinib or blinatumomab will be determined following review of their case by the investigator
Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
Patients receiving, or unable to stop use at least 1 week prior to receiving the first dose of BMX-001, medications listed in Section 12.2 of the protocol are not eligible.
Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving nivolumab
Concurrent use of CYP3A4 inhibiting or activating medications
Patient on anti-retroviral medications
Requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation
Currently taking a concomitant medication, other than a premedication, that is:
A known P-glycoprotein (P-gp) inhibitor or inducer. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ?1 week before dosing
Require therapeutic use of nonsteroidal anti-inflammatory drugs (NSAIDs)
History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible; use of immunosuppressant drugs such as systemic steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc.: systemic use is not permitted within 4 weeks before recruitment
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Concomitant chronic (daily or almost daily for >= 1 month prior) use of steroids or non-steroidal anti-inflammatory drugs (NSAIDS)
Use of medications that alter the absorption or metabolism of levothyroxine
Prior use of levothyroxine
Current use of a prohibited medication
No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy; limited doses of systemic steroids to prevent IV contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed
Current use of a prohibited medication including anticoagulants or platelet inhibitors or expected to require any of these medications during treatment with the investigational drug
Treatment with prohibited medications
Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
The use of natural or synthetic cannabinoids
Any prior use of Revlimid or Velcade
Planned use of maintenance or consolidative therapy
Able to take medications orally;
Previous use of TAS-114, S-1, and 5-FU drugs;
Medications known to lower the seizure threshold (see list under prohibited meds) must be discontinued or substituted at least 4 weeks prior to study entry
Prior use of apalutamide, abiraterone acetate or degarelix
Inability to interrupt use of non-steroidal anti-inflammatory drugs (NSAIDS)
Patient on anti-retroviral medication (as these medications may alter patient metabolism)
Sexually active males must use a condom during intercourse while receiving chemoradiation and for 90 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Current use of a prohibited medication or planned use of any forbidden medications during treatment with GSK3326595.
All outside study medications and supplements will be reviewed and monitored by the inpatient pharmacy team; patients will be discouraged from taking herbals and additional supplements
Be taking or require the use of prohibited medications
There are currently no known concomitant medications that must be discontinued prior to administration of registration on study and for the duration of sEphB4-HSA
Immunosuppressed state (e.g. HIV, use of chronic steroids)
Concurrent use of any of the following medications during study participation:\r\n* Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib\r\n* Medications which prolong the QTc interval and may predispose to torsades de pointes
The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal antiinflammatory drugs (non-steroidal anti-inflammatory drug [NSAIDs], including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
Patient requiring anti-diabetic medications to manage hyperglycemia are eligible; adjustments of other anti-diabetic agents will be made with close monitoring of blood glucose
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
Written authorization for use and release of health and research study information has been obtained
Prior use of ARN-509 (apalutamide)
Anticoagulants (i.e. Coumadin, heparin, anti-Xa inhibitors) and anti-platelet agents (i.e. aspirin) are not allowed; nonsteroidal anti-inflammatory drugs (NSAIDS) and acetaminophen are allowed on study
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving nivolumab
Treatment with the following medications are contraindicated with DSF when taken within 7 days prior to the first dose of DSF plus (+) Cu: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir; (Note: the following medications are not contraindicated but should be cautioned if taking concurrently with DSF: warfarin, phenytoin, theophylline, chlorzoxazone, chlordiazepoxide, diazepam; if the patient is taking warfarin, international normalized ratio [INR] should be monitored closely; if the patient has to remain on phenytoin, its serum concentration and response should be monitored closely)
Enzyme inducing anti-epileptic drugs
Use of medications that are known to prolong the QT interval and/or are associated with a risk of torsades de pointes 7 days prior to first dose
Use of medications that increase serum levels of phosphorus and/or calcium
Concurrent medical problems that preclude use of deep vein thrombosis (DVT) prophylaxis with lenalidomide treatment
Men on study must use a condom if having sex with a pregnant woman
Currently on the following concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study drug(s); the use of the following medications should be discontinued prior to initiation of protocol therapy and should be avoided during protocol therapy if reasonable alternatives exist\r\n* Erlotinib\r\n* Temozolomide
Prior use of niclosamide or allergies to niclosamide
Use of any anti-leukemic agents after relapse is documented (note that the use of these anti-leukemic agents given as post-transplant maintenance therapy is allowed in this study, e.g., subcutaneous or oral 5-azacytidine or FLT3 inhibitors for maintenance) for cohorts 1 and 2
Current or recent (within 10 calendar days prior to cycle 1, day 1) use of dipyridamole, ticlopidine, clopidogrel, or cilostazol
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
Use of medications that increase serum levels of phosphorus and/or calcium (e.g., calcium, phosphate, vitamin D, parathyroid hormone)
Use of herbal preparations/medications (including, but not limited to: St. John’s Wort, Kava, ephedra (ma huang), gingko bilboa, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to first dose
Use of medications that are known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes 7 days prior to first dose
Reported illicit drug use
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
Use of medications or supplements that are known to affect PSA within 30 days prior to informed consent, including toremifene citrate, finasteride, testosterone, dehydroepiandrosterone (DHEA) or other testosterone-like supplements; no dutasteride within 90 days prior to informed consent
Requires the use of home oxygen
Concurrent use of systemic steroids or chronic use of immunosuppressant medications; recent or current use of inhaled steroids is not exclusionary
Concurrent use of systemic steroids or immunosuppressant medications; recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Sexually active males unless they use a condom during intercourse while taking the drug and for 15 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment
Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.
Willing to stop herbal medications as directed by physician
Concurrent use of systemic steroids or immunosuppressant medications; recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary
PHASE I: A history of autoimmune disorders\r\n* Patients with autoimmune disease other than vitiligo (e.g., psoriasis, extensive atopic dermatitis, asthma, irritable bowel disorder [IBD], muscular sclerosis [M.S.], uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason are excluded from the study; any patient with an allo-transplant of any kind would be excluded as well, including xenograft heart valve; mild, intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded\r\n* Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, e.g., chronic obstructive pulmonary disease [COPD])\r\n* Known human immunodeficiency virus [HIV]-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due the possibility of affecting the response to tremelimumab, and the higher risk of active opportunistic infections
PHASE II: A history of autoimmune disorders\r\n* Patients with autoimmune disease other than vitiligo (e.g., psoriasis, extensive atopic dermatitis, asthma, IBD, M.S., uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason are excluded from the study; any patient with an allo-transplant of any kind would be excluded as well, including xenograft heart valve; mild, intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded\r\n* Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, e.g., COPD)\r\n* Known HIV-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due the possibility of affecting the response to tremelimumab, and the higher risk of active opportunistic infections
Any medication administered within 4 weeks prior to 1st dose of TAS3681 that is known to affect QT interval or arrhythmogenic
Currently use medications known to cause QT prolongation or Torsades de Pointes.
Concomitant use of any anti-cancer therapy or immune modifier.
Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) or other nonsteroidal anti-inflammatories known to inhibit platelet function; prophylactic use of anticoagulants is allowed
The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs ([NSAIDs], including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
AZD1775 is an inhibitor of breast cancer resistance protein (BCRP); the use of statins including Atorvastatin which are substrates for BCRP are therefore prohibited and patients should be moved on to non-BCRP alternatives
Herbal preparations are not allowed throughout the study; these herbal medications include, but are not limited to: St. John’s wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng
Currently being treated for smoking cessation, alcoholism, or illicit drug use
Sexually active males unless they use a condom during intercourse
Use of other drugs for the treatment of acute GVHD
Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum])
Medications known to lower the seizure threshold (see list under prohibited meds) must be discontinued prior to study entry
Post-prostatectomy use of ADT for > 30 days prior to study entry (ADT defined as the use of a GnRH agonist, with or without an anti-androgen)
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Is currently taking any prohibited medication(s)
Are taking medications with a known risk of Torsades de Pointes
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (Note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Current or planned use of agents that prolong or suspected to prolong QTc
4 or above for men OR 3 or above for women on the Alcohol Use Disorders Identification Test (AUDIT-C) are considered a “positive” screen and will require additional clinician assessment to determine if an alcohol use disorder is present
Current use of a smoking cessation medication (e.g. nicotine replacement, varenicline, bupropion)
Any concomitant medications that are known to be associated with Torsades de Pointes, that in the investigator’s opinion cannot be discontinued, are allowed however, must be monitored closely
History of QT prolongation associated with other medications that required discontinuation of that medication
Known or suspected malabsorption condition or obstruction; Note: Use of pancreatic enzyme supplements is allowed to control malabsorption
No dexamethasone use (or any other corticosteroid use with the purpose of treating cerebral edema) starting 5 days prior to the treatment planning MRI; patients may be tapered to meet this criterion if deemed safe by the treating physician
Previous use of indoximod or tergenpumatucel-L immunotherapy.
Use of prohibited drugs
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of antimicrobials that are considered to be essential for care of the patient
Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use
Subject is receiving medication(s) that might affect immune function; use of histamine type 2 (H2) antagonists are prohibited as are all antihistamines five days before and five days after each injection of study vaccine; however, nonsteroidal antiinflammatory drugs (NSAIDS) including cyclooxygenase-2 (COX-2) inhibitors, acetaminophen or aspirin are permitted
Patients who have contraindications to the use of nonsteroidal antiinflammatory drug (NSAID’s) like chronic renal failure, coronary artery disease, or bleeding ulcers
Thrombolytic use (except to maintain i.v. catheters) or anticoagulant use within 10 days prior to first day of study therapy
Chemotherapeutic agents for therapy of AML (note that prophylactic use of these agents is allowed in this study, e.g., methotrexate for GVHD)
Active drug use or alcoholism
Concomitant medications: the following drugs need to be stopped at the time of beginning therapy: patient cannot be on liver enzyme inducing anticonvulsants; patients must not have received growth factors to support the number or function of white cells or platelets within the past 7 days and pegfilgrastim within the past 14 days; patients must not be receiving any anti-thrombotic or anti-platelet agents; patient cannot be on drugs that cause significant prolonged QT (category I drug)
Other drugs permitted but use with caution include; drugs are not recommended but can be used with caution\r\n* Antacids: use of H2 blockers and proton pump inhibitors is not recommended; patients who require antacids should use short acting, locally active agents (e.g., Maalox, Mylanta etc.); however, these agents should not be taken within either 2 hours before or 2 hours after the dasatinib dose\r\n* Drugs prolong QT interval; erythromycin, clarithromycin, pentamidine, ondansetron, granisetron, and methadone
Failure to use contraception in patients with preserved reproductive capacity
Concurrent treatment or medications (must be off for at least 1 week) including:\r\n*Interferon (e.g. Intron-A)\r\n*Allergy desensitization injections\r\n*Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n*Interleukins (e.g. Proleukin)\r\n*Any investigational therapeutic medication
Concomitant medications:
Suspected malabsorption or obstruction; note: use of pancreatic enzyme supplements is allowed to control malabsorption
Use of zidovudine as part of the HAART regimen (a drug substitution for zidovudine at the time of study entry is allowed)
Prior use of pegylated interferon or interferon
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Subjects receiving class III antiarrhythmic medications
Use of antiplatelet agents other than low-dose aspirin
Patients on medications known to be associated with torsades de pointes
Plan to use other nicotine substitutes (i.e., over-the-counter [OTC] or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months
Current use of certain medications: (1) smoking cessation meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, nicotine replacement therapy (NRT), Chantix, (2) certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (Amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however pro re nata (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month’s duration)
Subjects must be competent to report adverse events (AEs), understand the drug dosing schedule and use of medications to control AEs
Current use of a prohibited medication or requires any of these medications during treatment with study drug
Unwilling to use nicotine replacement therapy (NRT) patches
Non-compliant to medications
Use of herbal medications
Current use (or planned use during the treatment period) of other investigational agents, or biological, chemotherapy, radiation or other anti-tumor therapy
Patients on other essential medications for which an interaction with ketoconazole can be expected and for which dose reductions to other essential medications cannot be made in a manner adequate to ensure patient safety
Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible)
Patients at risk for gastrointestinal bleeding (example: peptic ulcer disease, prolonged daily non-steroidal anti-inflammatory use)
Poorly-controlled diarrhea (> 4 loose bowel movement [BM]/day without use of anti-motility agents) within 7 days of study enrollment; patients may be reconsidered for the study if the diarrhea resolves
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study; (note: megestrol [Megace] if used as an appetite stimulant is allowed; thyroid-stimulating hormone [TSH] suppressive therapy is also allowed; palliative radiation therapy to non-target lesions is also allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Sexually active males who are unwilling to use a condom during intercourse while taking drug and for 6 months after stopping investigational medications and agree not to father a child in this period
Prior use of agents for TNF-alpha blockade
Subjects on systemic medications known to affect the Hedgehog pathway
> 10 pack years of tobacco use or more
Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug; herbal medications include, but are not limited to St. John’s wort, Kava, ephedra (ma huang), Gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; fruits include the cytochrome P450, family 3, subfamily A (CYP3A) inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\n* Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded
Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 4 weeks after stopping treatment
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\n* The following concomitant medications are not allowed during navitoclax administration: warfarin, clopidogrel (Plavix), ibuprofen, tirofiban (Aggrastat), and other anticoagulants, drugs, or herbal supplements that affect platelet function are excluded, with the exception of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor
Active epilepsy or convulsive conditions that require continuous use of anticonvulsants
Able and willing to provide written authorization for use and release of health and research study information
Concurrent use of systemic steroids or immunosuppressant medications
Non-compliant to medications
Currently taking cholestyramine or orlistat
Ongoing use of total parental nutrition
Patients who are currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and/or opioid pain medications must remain on a stable dosage throughout the duration of the study
Prior use of duloxetine or milnacipran
Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecainide, linezolid, or anticoagulation medication (e.g., heparin, warfarin); treatment with monoamine oxidase (MAO) inhibitor within 14 days prior to registration
Concomitant use of anthracyclines or use of anthracyclines in the last 50 days
Concomitant use of drugs with a risk of causing torsades de pointes
Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course; use of corticosteroids are not considered an exclusion criteria
Use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before treatment
Initiation or discontinuation of bisphosponate use within past 14 days\r\n* Continuation of use is allowed but patients must continue bisphosphonate throughout the treatment and follow up period until disease progression
Seizure disorder necessitating the use of enzyme-inducing antiepileptic drugs (EIAEDs); efforts may be made by the treating physician to change the antiepileptic drug from another agent to valproic acid or non-EIAED prior to excluding the patient from study
Both genders must use contraception if of reproductive capacity
While participating, subjects must agree not to use soy supplements, over the counter estrogen supplements like Estroven, Chinese herbs, or other over-the-counter (OTC) herbal products
Concurrent treatment or medications (must be off for at least 1 week) including:\r\n* Interferon (e.g. Intron-A)\r\n* Allergy desensitization injections\r\n* Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n* Interleukins (e.g. Proleukin)\r\n* Any investigational therapeutic medication
If taking immunosuppressants, retinoids or anti-neutrophil therapy, participants must maintain stable doses of these medications during the 2 weeks prior to study initiation
Any prior use of pomalidomide
Patients who cannot discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment
COHORT 3: ATOPIC DERMATITIS PATIENTS: Use of topical corticosteroids on all intended sampling sites within 7 days, prior to baseline sampling
Ponatinib\r\n* Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from randomization through 4 months after the end of treatment\r\n* Discontinuation of any medications known to contribute significantly to the risk of QT prolongation at least 48 hours prior to start of study drug; Levaquin and Zofran are an exception; of note, certain agents that prolong the corrected QT interval (QTc) may be allowed but only after discussion with the chemotherapy pharmacist; should the investigator believe that therapy with a potentially QT prolonging medication is vital to an individual subject’s care, then additional electrocardiograms (ECGs) should be done at the investigator’s discretion to ensure the subject’s safety\r\n* Serum lipase =< 1.5 x ULN\r\n* Serum amylase =< 1.5 x ULN
Dasatinib use prior to ASCT is allowed
Patients who may be receiving any enzyme-inducing antiepileptic drugs (EIAED) within 2 weeks prior to registration, or any other prohibited medications within the washout period prior to registration
Concomitant medications, if taken within the last 28 days
Concomitant use of bisphosphonates is allowed
Subject is receiving potent inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); for such medications, a wash-out period of >= 7 days is required prior to starting dasatinib unless discontinuation or substitution of such an inhibitor is not in the best interest of the patient as determined by the investigator; these include the following medications: itraconazole, ketoconazole, miconazole, voriconazole; amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir; ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, isoniazid, ketamine, nefazodone, nicardipine, propofol, quinidine, telithromycin; in instances where use of these agents is felt to be required for the best management of the patients, inclusion of such a patients should be discussed with principal investigator (PI) and the rationale documented
Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins)
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes (unless these can be changed to acceptable alternatives)
Patients must be willing to use the Optune device >= 18 hours/day for at least 23 days in a 28-day cycle, and keep head shaved throughout treatment
Planned use of Optune
Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate; participant must be off any EIAEDs for at least 7 days prior to planned start of study treatment; among non-EIAED, caution is recommended with use of valproic acid due to potential for drug interaction
Current use of herbal preparations/medications, including but not limited to: St. John’s wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng; participants should stop using these herbal medications 7 days prior to planned start of study treatment
Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior); all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4
Prior use of duvelisib if discontinued due to toxicity
Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes.
Receiving medications that can effect clotting ability: warfarin, aspirin, (once-daily aspirin use- maximum dose 325 mg/day is permitted), nonsteroidal anti-inflammatory drugs (nonsteroidal antiinflammatory drug [NSAID]s, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents
Have a peripheral blast count of >30,000/mm3 (may use hydroxyurea as in #5 above)
Not willing to discontinue use of supplemental vitamin E
Are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).
Patients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medications
Patients who require the use of therapeutic anti-coagulation: except as required to maintain patency of preexisting permanent vascular catheter
Concomitant use of any enzyme inducing anticonvulsants is not allowed
Concurrent treatment or medications (must be off for at least 1 week) including:\r\n* Interferon (e.g. Intron-A)\r\n* Allergy desensitization injections \r\n* Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n* Interleukins (e.g. Proleukin)\r\n* Any investigational therapeutic medication
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Prior use of gossypol or AT-101
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of lenalidomide.
Current use of illicit drugs, glucocorticoids other than those necessary for concurrent radiotherapy, adrenal failure or septic shock, or other immune-suppressing or immune-modulating drugs. Glucocorticoids for anti-emetic prophylaxis and therapy should only be used as a last resort.
Use of iron chelators
Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
Concomitant medications:
Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
Any other prohibited or restricted medication as described in the study protocol.
Use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants within 1 week of enrollment
Therapeutic anti-coagulative or long-term anti-platelet treatment. Use of low dose acetylsalicylic acid (ASA) up to 81 mg/day and non-ASA nonsteroidal anti-inflammatory drugs (NSAID) is allowed.
Current use of antibiotic rinses or troches
Known sensitivity to any study medication
Current use of prohibited medications
Any prohibited concomitant medication as per protocol within 28 days of Screening
Use of immunosuppressant medications within 4 weeks of MCLA-117 administration;
The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
Use of any medications known to affect the serum androgen level
Prior use of any experimental or approved C-C chemokine receptor type 5 (CCR5) modulators including maraviroc and PRO 140
Recent use of photosensitizing agents such as fluoroquinolones and retinoids or patients undergoing phototherapy.
A requirement for a calcium channel blocker for blood pressure control that cannot be switched to an antihypertensive with an alternative mechanism of action; permitted anti-hypertensive medications include: chlorothiazide, hydrochlorothiazide, atenolol, nadolol, enalapril, lisinopril, eprosartan, and irbesartan
Patients who are taking and cannot discontinue over-the-counter (OTC) medications and nutritional supplements, including herbal or \Chinese\ medications, are not eligible, except if using the following OTC medications that are allowed at labeled doses, acetaminophen, aspirin, diphenhydramine, calcium carbonate antacids, branded multiple vitamin supplements and pseudoephedrine; topical preparations and decongestant nasal sprays are allowed
Receiving any medications or substances with risk of torsades de pointes; Note: medications or substances on the list \Drugs with Risk of Torsades de Pointes\ are prohibited; medications or substances on the list \Drugs with Possible or Conditional Risk of Torsades de Pointes\ may be used while on study with extreme caution and careful monitoring
Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications.
Concomitant use of medications associated with a high incidence of QT prolongation
Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug; herbal medications include, but are not limited to St. John’s wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; fruits include the CYP3A inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
Inclusion Criteria:\n\n        Patients must meet all of the following inclusion criteria to be eligible for enrollment:\n\n          -  Ability to understand the risks, benefits, and alternative to participation and give\n             informed consent\n\n          -  Have biopsy proven skin cancer on the medial forehead that is amenable to Mohs\n             surgery. Medial forehead is defined as the area superiorly from the hairline,\n             inferiorly at the eyebrow, and laterally to the tip of the lateral brow (see diagram).\n\n          -  Undergoing elective reconstruction of biopsy proven skin cancer that is amenable to\n             Mohs surgery with defect size measuring 1.0 cm or greater\n\n          -  If female, not currently pregnant, no potential for pregnancy, or if of child-bearing\n             age, must agree to use adequate contraception (e.g., hormonal or barrier method of\n             birth control; abstinence) for 30 days after the last dose of study drug. A negative\n             urine pregnancy test is required at study entry for female subjects of childbearing\n             potential: a woman is considered to be of child bearing potential unless she has had a\n             tubal ligation, total hysterectomy, bilateral oopherectomy, or is postmenopausal\n             (without a menstrual period for at least one year)\n\n          -  Agrees to not use disallowed concomitant medications (retinoids)\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a patient from study enrollment.\n\n          -  Pregnant women, women who are breastfeeding, or women of child bearing age who are\n             unwilling to use adequate contraception (described above) during the study period\n\n          -  Current or past history of a neuromuscular disease (such as myasthenia gravis,\n             amyotrophic lateral sclerosis, Eaton-Lambert syndrome)\n\n          -  Currently taking aminoglycosides or other agents interfering with neuromuscular\n             transmission (e.g., curare-like agents)\n\n          -  History of radiation therapy or chemotherapy\n\n          -  History of keloid or other hypertrophic scar formation\n\n          -  Current or past history of scleroderma\n\n          -  Has used botulinum toxin in the forehead area within one year.\n\n          -  Has significant resting eyebrow ptosis\n\n          -  Has used any topical retinoids to the forehead area within the past 4 weeks\n\n          -  Undergo any scar revision procedure for the duration of the study including\n             intralesional kenalog, laser treatment, and/or scar revision surgeries\n\n          -  Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein) or\n             any previous hypersensitivity to any botulinum toxin A or related product.\n\n          -  Non-English speaking: These patients are excluded since translation of the informed\n             consent into other languages is time-consuming and expensive as it requires a bona\n             fide translator for the particular language of interest and this type of person may be\n             difficult to locate.\n\n          -  House staff and students, medical students on a clerkship, and employees related to\n             study personnel or who work for any study personnel, and members of the study team are\n             not eligible to participate in this study as a subject.\n\n          -  The investigator feels that for any reason the subject is not eligible to participate\n             in the study
Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Concurrent use of phenothiazine and atypical antipsychotics
Willingness to not use illicit drugs during study period including marijuana.
Contraindications to use of bupropion (i.e., concurrent use of other forms of bupropion, MAO inhibitors, anti-depressant medication, seizure disorder or any clinical situation that might increase risk for seizures, past head injury, current or prior diagnosis of bulimia or anorexia nervosa; bipolar disorder).
Contraindications to use of naltrexone (i.e., past history of opioid abuse or dependence or evidence of opioid use in the past 30 days; significant hepatocellular injury as evidenced by liver enzyme levels over 3 times normal limits).
Use of medications whose metabolism or effects may be adversely altered by bupropion or naltrexone. Medications that contraindicate the use of bupropion include theophylline, procarbazine, carbimazole, nialamide, pargyline, toloxatone, iproniazid, and systemic steroids. Medications that contraindicate the use of naltrexone include opioid analgesics and yohimbine.
Current use of anti-seizure medications, disulfiram, or any medications that significantly challenge liver functioning.
Self-reported use of illicit drugs in the past 90 days (including opioids, but excluding marijuana).
Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins
No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents (including intravenous immunoglobulin [IVIG]) within 8 weeks of study entry; note: use of topical, inhaled and intranasal steroid therapy is permitted
exclude use of acetaminophen or acetaminophen-containing medications from 1 day before to 1 day after completion of treatment. The active metabolite of acetaminophen, N-acetyl-p-benzoquinone imine (NAPQI), is known to block effects of cenersen & use of acetaminophen during treatment with study regimen has been associated with a failure to achieve a response in a past clinical trial of cenersen.
Note: Current or recent use of intra-articular, topical or inhaled glucocorticoid therapy is acceptable;
Herbal preparations are not allowed throughout the study; these herbal medications include but are not limited to: St. John's wort, kava, ephedra (ma hung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng; patients should stop using these herbal medications 7 days prior to first dose of study treatment
Provided written authorization for use and release of health and research study information.
Receipt of any vitamin K antagonists, systemic corticosteroids, live vaccines, or treatment with any anticancer medications or investigational drugs within the protocol-defined intervals.
Prior use of SERM
Women treated previously with 5-fluorouracil or imiquimod or other medications for high-grade squamous intraepithelial lesions will be excluded from the study
Use of anticoagulant medications
Prior use of androgen deprivation including enzalutamide
Sexually active males unless they are willing to use a condom during intercourse while taking the drug and for 15 days after stopping treatment and are willing to forego fathering a child in this period; a condom is required to be used also by vasectomized men
Significant co-morbid respiratory disease that contraindicates the use of bleomycin
Patients must not be receiving other medications known to prolong the QT interval at the time of study entry or while on protocol therapy
Herbal preparations are not allowed throughout the study. These herbal medications include but are not limited to: St. John's wort, kava, ephedra (mahung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng. Patients should stop using these herbal medications 7 days prior to first dose of study treatment.
Concomitant use of bisphosphonates, receptor activator of nuclear factor kappa-? ligand (RANKL) antibody, and ovarian suppression is allowed
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g. acyclovir), other than intermittent topical use; patients requiring anti-herpetic prophylaxis during chemotherapy are excluded
Concurrent therapy with any of the following (all must have been discontinued or substituted for at least 1 week prior to randomization, except for medications known to lower seizure threshold which must be discontinued or substituted at least 4 weeks prior to randomization)
Received > 24 hours of systemic antibacterial therapy within 72 hours of the initiation of inpatient IV study drug for treatment of suspected infection; antibiotic prophylaxis is allowed; prophylactic use of antiviral or antifungal medication is permitted
Exclusion criteria related to study medication:\r\n* Current or recent (within 10 days of study enrollment) use of acetylsalicylic acid (> 325 mg/day), clopidogrel (> 75 mg/day) or current or recent (within 10 days of first dose of bevacizumab) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose. Note: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or partial thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks at the time of cycle 1 day 1. Prophylactic use of anticoagulants is allowed\r\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\r\n* Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells, any components of binimetinib, pembrolizumab, or bevacizumab formulations or any premedications\r\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, anti-PD L1, anti-PD-L2 or MAPK pathway inhibitors (eg; BRAF, MEK, ERK inhibitors)\r\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization
Patients taking medications with known significant drug interactions
Patients on supraphysiologic doses of steroids or use of such =< 6weeks prior to registration
Use of any drug with histone deacetylase (HDAC) inhibiting activity.
Subject is receiving prohibited medications or treatments that cannot be discontinued/replaced by an alternative therapy
Concomitant use of drugs known to cause QT prolongation (Note: Ondansetron at doses ? 16 mg or less is allowed)
Unable or unwilling to stop the use of herbal supplements; the use of marijuana or its derivatives is allowed; the use of nutritional supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of ibrutinib or ability to adhere to the Revlimid REMS program will be determined following review of their case by the principal investigator
Use of treatments in the past 2 months that can affect VMS (e.g., use of oral or transdermal hormone therapy [HT] or contraceptives)
Current use of a prohibited medication
Receiving any medications that prolong the QTc and have a known risk for Torsades de pointes; providers should use caution with drugs with possible increased risk for Torsades de pointes; NOTE: patient will be eligible if they can be taken off these medications prior to initiation of therapy and no less than 4 half-lives of the medication
Current use of certain concomitant medications due to mechanistic-based platelet toxicities from navitoclax: clopidogrel, ibuprofen, tirofiban and other anticoagulants, drugs or herbal supplements that effect platelet function; NOTE: antiplatelet use is prohibited during the use of navitoclax; subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the principal investigator in conjunction with the medical monitor
Concurrent use of high dose aspirin (doses up to 81 mg oral dose daily allowed) and non-steroidal anti-inflammatory drugs (NSAIDS), except for where NSAIDs provide documented benefit over other analgesics, and then to be used with caution including concomitant use of proton pump inhibitors).
Subjects who have experienced a seizure or seizures within 6 months of study treatment or who are currently being treated with cytochrome P450 enzyme inducing anti-epileptic drugs for seizures (use of anti-epileptic drugs to control pain is allowed in subjects not suffering from seizures unless drug is excluded due to Cytochrome P450 3A4 induction - phenytoin, carbamazepine, Phenobarbital.
Patients may not use herbal or non-traditional medications while receiving AMG 232 therapy; all herbal medicines (e.g., St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 232 should be reviewed by the principal investigator
Treatment with medications known to cause QTc interval prolongation within 7 days of study day 1 is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Patients with a planned use of Novo-TTF (Optune) are ineligible
Current use of herbal preparations/medications, including but not limited to: St. John’s wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng. Participants should stop using these herbal medications 7 days prior to first dose of study drug
Viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use
Patients with current use of megestrol acetate (use within 10 days of day 1) will be excluded
Prior use of steroidal antiandrogens (megestrol acetate, cyproterone acetate), AR partial agonists, ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals within 3 months before registration and during administration of study treatment
All herbal medicines (e.g., St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 232, and continuing use, if applicable, will be reviewed by the principal investigator
Use of any known CYP3A4 substrates with narrow therapeutic window (such as alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, sirolimus, or terfanide) within the 14 days prior to receiving the first dose of AMG 232 is not permitted; other medications (such as fentanyl and oxycodone) may be allowed per investigator’s assessment/evaluation
Treatment with medications known to cause QTc interval prolongation within 7 days of study day 1 unless is not permitted unless approved by the sponsor; use of ondansetron is permitted for treatment of nausea and vomiting
Patients with BP combination treatment with more than two antihypertensive medications are ineligible
Concomitant systemic treatment with chronic use of anti-histamine or non-steroidal anti-inflammatory drugs and other platelet inhibitory agents and patients on oral anticoagulant (e.g. warfarin)
Viral infections requiring intermittent or chronic systemic (intravenous or oral) treatment with an anti-herpetic drug, other than intermittent topical use (e.g., acyclovir)
DOSE ESCALATION COHORT: Current or anticipated use of other investigational agents while participating in this study
DOSE EXPANSION COHORT: Current or anticipated use of other investigational agents while participating in this study
Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice; the topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed
Patients receiving medications for treatment of left ventricular systolic dysfunction
Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed
While there will be no restrictions on concurrent systemic medications, all subjects must be on a stable immunomodulatory medication regimen for 7 days prior to beginning the study without plans to adjust doses during the following four-week study period; dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) during the study intervention period are allowed and do not constitute a trial violation; changes in medications for non-cGVHD medical conditions will not affect eligibility
Any concomitant medications that are known to be associated with Torsades de Pointes or QT elongation
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Concomitant medications required on dosing days that increase risk of torsades de pointes
Subjects using certain medications
Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug; herbal medications include, but are not limited to St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; fruits include the cytochrome P450, family 3, subfamily A (CYP3A) inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
Patients must also be offered participation in banking for future use of specimens
Prior use of enzalutamide
Current or planned use of prohibited meds
Patients who are taking any of the prohibited medications; if a patient is willing to discontinue such a medication in order to participate in the study, then there must be an appropriate washout period, based on the half-life of the particular drug, prior to the start of the study treatment
Prior use of regorafenib
Patients receiving medications that have the potential to prolong the QT interval
Concurrent use of known cytochrome P450 3A4 (CYP 3A4) inhibiting or activating medications
Use of strong CYP inhibitors or drugs that carry a definite risk of torsades de pointes. Please consult the medication prescribing information prior to prescribing new medications to make sure that the new medication is not a strong CYP inhibitor. Moderate CYP inhibitors should be avoided if possible
Patients must not be planning to receive any concomitant medication known to prolong QT interval
Patients must also be offered participation in banking for future use of specimens
Patients must also be offered participation in banking for future use of specimens
Sexually active males unless they use a condom during intercourse while taking the drug and for 21 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited: the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
Patients who are currently receiving aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs or anti-platelet agents are not eligible
Concurrent use of enzyme-inducing anti-epileptic drugs (EIAED); patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs; patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of MLN0128
Concurrent use of herbal supplements and other non-traditional medications; all herbal supplements and other non-traditional medications must be stopped before time of registration
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug; if an alternative medication that does not risk QT prolongation can safely be used in the opinion of the treating physician and the treatment is changed to that medication, the patient may be enrolled
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to enrollment; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Drugs that potently inhibit or induce CYP3A4 should be administered with caution; below are a few examples of the agents:\r\n* Drugs that may increase exposure of trametinib (CYP3A4 inhibitors):\r\n** Antivirals: amprenavir, atazanavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir\r\n** Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin\r\n** Antifungals: fluconazole, itraconazole, ketoconazole, voriconazole\r\n** Antidepressants: nefazodone\r\n** Calcium channel blockers: mibefradil, diltiazem, verapamil\r\n** Miscellaneous: aprepitant\r\n* Drugs that may decrease exposure of trametinib (CYP3A4 inducers)\r\n** Antivirals: efavirenz, nevirapine\r\n** Antibiotic: rifampin\r\n** Anticonvulsants: carbamazepine, phenobarbital, phenytoin\r\n* Caution should be exercised when dosing trametinib concurrently with medications with narrow therapeutic windows that are substrates of CYP2C8; below are a few examples of the agents\r\n** Drug metabolism potentially affected by trametinib resulting in increased exposure of these substrates\r\n*** 3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA)-reductase inhibitors: cerivastatin\r\n*** Thiazolidinediones: rosiglitazone, pioglitazone\r\n*** Miscellaneous: chloroquine, zopiclone, repaglinide\r\n* As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of BMN 673 will be determined following review by the principal investigator
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s Wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
No systemic steroid use within 2 weeks prior to initiation of experimental therapy; limited doses of systemic steroids to prevent intravenous (IV) contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed
Concomitant use of these drugs at baseline and for the duration of digoxin administration (if randomized to receive it):\r\n* The calcium channel blockers diltiazem or verapamil\r\n* Cardiac arrhythmic agents (such as quinidine, amiodarone)\r\n* Other cytochrome P450 (P450) inducer/inhibitors\r\n* NOTE: patients already receiving digoxin are also excluded; patients who take calcium carbonate antacids (e.g., Maalox, Tums, Rolaids) or antidiarrheal adsorbents (kaolin and pectin) should avoid taking these at the same time as the digoxin dose
Eligibility of patients receiving any medications or substances known to affect or with potential to affect the activity or pharmacokinetics of temsirolimus and/or sorafenib will be determined following review of the case by the study chair; efforts should be made to switch patients who are taking enzyme-inducing anti-convulsant agents to other medications
Patients chronically receiving medications known to be metabolized by cytochrome P 450, family 3, subfamily A, polypeptide 4 (CYP3A4) and with narrow therapeutic indices including pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; the topical use of these medications (if applicable) is allowed
Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, miconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed
Current use of more than one antihypertensive medication.
Active autoimmune disease, chronic inflammatory condition, conditions requiring concurrent use of any systemic immunosuppressants or steroids; mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded
Use of clobetasol ointment intra-orally at any time during the last 6 weeks period
Patient must not be taking any herbal supplements during the study (including but not limited to St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng); if a potential patient is taking any herbal supplements, s/he must discontinue prior to beginning study treatment
Current use of a prohibited medication
Receiving a medication with known risk of torsades de pointes; the following medications are specifically prohibited: amiodarone, arsenic trioxide, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, dolasetron, droperidol, erythromycin, halofantrine, haloperidol, ibutilide levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, quinidine, sotalol, sparfloxacin, and thioridazine; patients should be watched carefully for indications of torsades de pointes, such as syncope; performing additional electrocardiograms (EKGs) on subjects who must take one or more of these medications is not required; however, additional investigations, including EKGs, may be performed as per the treating physician’s judgment
Must not have retinal or visual field changes from prior 4-aminoquinoline compound use
Certain medications that are associated with a risk for QTc prolongation and/or torsades de pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
Participants on an antiretroviral regimen should be receiving treatment that is in accordance with the current International acquired immune deficiency syndrome (AIDS) Society guidelines; the specific agents are at the discretion of the investigator and use of agents currently available on an expanded access basis is allowed but use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) are prohibited; changes to highly active anti-retroviral therapy (HAART) therapy may be made if medically necessary (toxicity, failure of regimen, etc.); antiretroviral naïve participants: participants who are not on HAART at study entry MUST begin therapy (utilizing the above guidelines) AFTER one cycle of chemotherapy has been completed under protocol; changes to HAART therapy may be made if medically necessary (toxicity, failure of regimen, etc.); concurrent therapy with zidovudine or a zidovudine-containing regimen (including Combivir and Trizivir) will be prohibited until 2 months following the participant’s completion of chemotherapy as part of this protocol; the use of cobicistat (e.g., Tybost), or cobicistat containing single tablet regimens (e.g., Stribild) is prohibited during concurrent chemotherapy under this protocol; participants taking cobicistat or cobicistat-containing single table regimens must switch to a different agent or regimen prior to enrollment, and will remain on the regimen until at least 2 months following treatment discontinuation; Cobicistat is a pure and potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor and has the potential to increase the area under the curve (AUC) of CYP3A4 substrates; therefore, both vincristine and doxorubicin would have the potential for drug drug interaction (DDI) with cobicistat since they are CYP3A4 substrates
Use of zidovudine or cobicistat as part of the HAART regimen (a drug substitution at the time of study entry is allowed)
Institutions must seek additional patient consent for the banking and future use of specimens
Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to, ketoconazole, itraconazole, miconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed
Use of alemtuzumab
Use of T-cell depleting agents
Use of alemtuzumab
Patients must also be offered participation in banking for future use of specimens
Is currently taking any prohibited medication(s)
Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted
Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is permitted.
Patients taking medications that are known to prolong the QT interval
Receipt of anticancer medications or investigational drugs within protocol-specified intervals
Current anthracycline use
Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use
Patients taking medications that are known to prolong the QT interval unless they can be transferred to other medications within ?5 half-lives prior to dosing, or unless the medications can be properly monitored during the study.
Willing to discontinue all herbal preparations/medications at least 7 days prior to the first dose of study drug and throughout the study; these include, but not limited to, St. John's wort, Kava, ephedra (ma huang), ginkgo biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng
Any significant ophthalmologic abnormality. The use of contact lenses is not recommended during the study.
PRIOR/CONCURRENT THERAPY CRITERIA: The concurrent use of all herbal supplements is prohibited during the study (including but not limited to St. John’s Wort, kava, ephedra [ma huang], ginko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti-inflammatory drugs and aspirin permitted) or conditions such as common variable hypogamma-globulinemia or exposures such as large field radiotherapy
Subject is currently using or use within 6 months of illicit drugs.
Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks prior); all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects of CYP3A4
Excessive alcohol intake should be avoided (occasional use is permitted)
Required use of medications predominantly cleared by hepatobiliary transporters within 48 hours of study drug infusion
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Patients may not be receiving any other anti-cancer or investigational agents\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Patients who require use of a concomitant medication that can prolong the QT interval
Taking any drugs associated with torsades de pointes or known to moderately or severely prolong the QTc(F) interval
Patients must also be offered participation in banking for future use of specimens
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ?1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Sites must seek additional patient consent for the future use of specimens
Is able to take medications orally (ie, no feeding tube).
Subject is currently receiving treatment with any agent listed on the prohibited medication list
Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti- inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy
Uncontrolled glaucoma (topical medications allowed)
The use of concomitant antioxidants, such as vitamin C or E, is not allowed
Clinical history, current alcohol (ethanol), or illicit drug use which, in the judgment of the investigator, will interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.
Taking any medication known to moderately or severely inhibit the CYP3A4 isozyme or any drugs that are CYP3A4 inducers (including anti-epileptic agents such as phenytoin). A stable regimen (? 4 weeks) of antidepressants of the SSRI class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline, and fluoxetine)
Taking any drugs associated with torsades de pointes or known to moderately or severely prolong the QTc(F) interval
Use of anti-coagulant agents or history a significant bleeding diathesis. (If a superficial lymph node or subcutaneous mass is to be injected, patients on agents such as non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or clopidogrel are eligible and these agents do not have to be withheld. For procedures with moderate or significant risk of bleeding, long-acting agents such as aspirin or clopidogrel should be discussed with the Medical Monitor and may need to be discontinued before G100 therapy. For patients enrolled in Part 2 with the potential to receive pembrolizumab:
Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
Use of systemic corticosteroid.
Be willing to use dexamethasone mouthwash as directed
Prior eribulin use
Patients are excluded if they have current or recent (within 10 days of enrollment) use of aspirin (> 325 mg/day) or chronic use of other non-steroidal anti-inflammatory drugs (NSAID)
Patients are excluded if they use medications that inhibit platelet function (e.g., dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and ibuprofen and related compounds) unless subject has been off treatment for at least 2 weeks prior to randomization
Written authorization for use and release of health and research study information has been obtained
Current use of a prohibited medication or requires any of these medications during treatment with the investigational drugs (details will be available in the protocol). This includes excluding current medications known or suspected to be associated QT prolongation. In addition, any subject who may require a QT prolonging medication while on trial should not be enrolled.
Patients are ineligible if they plan on regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required
Is currently taking any prohibited medication(s)
Use of any vascular endothelial growth factor (VEGF) targeted therapy or previous use of regorafenib.
Require treatment with any of the exclusionary medications listed in Appendix D.
Use of the following medications within 6 months prior to EC1169 administration: amiodarone, disopyramide, dofetilide, dronedarone, flecanamide, ibutilide, quinidine, or sotalol
Use of medications that have been linked to the occurrence of torsades de pointes
Patients receiving QT prolonging medications (such as ondansetron)
Treatment with medications that are known to carry a risk of Torsades de Pointes.
Currently receiving any prohibited medications including vitamins and herbal supplements
Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval
Requirement for concomitant medications that strongly induce or inhibit CYP3A4/5
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Any prior use of lenalidomide
Current or recent (within 10 calendar days prior to cycle 1, day 1) use of dipyramidole, ticlopidine, clopidogrel, or cilostazol
Absolute neutrophils count inferior to 1000 per ?L (1 x 10E9/L). The use of G-CSF is not allowed to reach this level.
Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ?28 days before study treatment
Prior use of lenalidomide
Participants requiring daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug.
Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication
Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
Medications that have a known risk to prolong the QT interval or induce Torsades de Pointes
Herbal preparations/medications, dietary supplements.
Herbal preparations/ medications
Discretionary use of growth factors allowed
Prior use of regorafenib.
Use of any medications that induce, inhibit, or are substrates of CYP450 3A4
Current use of any drugs with a known risk of causing torsades de pointes
Herbal preparations/medications, dietary supplements.
The use of dietary supplements or herbal medications within 7 days of starting study therapy
Patients must not be concurrently taking other medications or supplements with known hormonal effects (other than LHRH agonists or non-steroidal antiandrogen), including prostate cancer (PC)-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or saw palmetto; all other medications with possible anti-cancer effects must be discussed with the protocol principal investigator prior to study entry
Concomitant medications causing prolonged QT which cannot be discontinued or changed to a different medication prior to initiating study
Sexually active males, unless they use a condom during intercourse while taking the drug and for 15 days after stopping treatment; they should not father a child in this period; a condom is required to be used also by vasectomized men
Patients that are on enzyme-inducing anti-epileptic medications
Patient must be able to take p.o. medications.
Current use of a prohibited medication including anticoagulants or platelet inhibitors or expected to require any of these medications during treatment with the investigational drug.
Not currently be taking tomato carotenoid dietary supplements or “alternative” products (e.g., lycopene supplements, Lyc-O-Mato, saw palmetto); vitamin A and beta-carotene supplements are allowed
Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
Are planning to start certain medications after the trial enrollment; no new finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing new prescription medications for urinary outlet obstructive symptoms will result in discontinuing participation in this study; the use of new non-prescription substances to improve urinary tract symptoms will also result in discontinuing participation (i.e. saw palmetto, other herbal, alternative products); men who are currently taking finasteride or medications (meds) for urinary outlet obstructive symptoms may enroll in the study as long as there is no plan to change the dose in the weeks prior to surgery
Current or anticipated use of enzyme-inducing anti-epileptic drugs (EIAED)
Is able to take medications orally
Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 6 months.
Prior use of lenalidomide.
Patients currently taking medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug)
Not currently taking steroids
Current use of steroids
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
The following agents are not permitted while patients are taking MLN8237, and should be discontinued at prior to registration if patients are taking them:\r\n* Patients must stop using the proton pump inhibitor (PPI) for at least 4 days prior to the first dose of MLN8237; administration of PPI while on study is not permitted\r\n* Histamine-2 (H2) receptor antagonists are not permitted from the day prior through to the end of MLN8237 dosing, except as required for premedication for rituximab; constant dosing of H2 blockers is not permitted\r\n* Antacid preparations are not permitted for 2 hours before or 2 hours after administration of MLN8237\r\n* Administration of pancreatic enzymes is not permitted at any time while on study\r\n* Co-administration of enzyme-inducing antiepileptic drugs, rifampin, rifabutin, rifapentine or St. John's wort is not permitted\r\n* Concurrent bisphosphonate therapy is allowed if it was started before study entry and is maintained at recommended dosing intervals; if bisphosphonate therapy is initiated after study entry, bone lesions will not be considered evaluable for disease response\r\n* Patients must be willing not drive, operate dangerous tools or machinery, or engage in any other potentially hazardous activity that requires full alertness and coordination if they experience excessive sedation; if a patient experiences excessive sedation believed to be related to MLN8237, treatment with MLN8237 should be interrupted\r\n* Patients must be willing to limit alcohol consumption to no more than 1 standard unit of alcohol (12 oz beer [350 mL], 1.5 oz [45 mL] of 80-proof alcohol, or one 6-oz [175 mL] glass of wine) per day during the study and for 30 days from the last dose of MLN8237; minimize the use of agents with central nervous system (CNS) effects\r\n* Benzodiazepine use is discouraged but not prohibited
Chronic or planned acute alcohol use of 3 or more drinks per day
Sensitivity to any of the study medications or any of the ingredients or excipients of these medications
Due to the potential interaction between nilotinib and enzyme-inducing anti-epileptic drugs (EIAED - phenytoin, fosphenytonin, carbamazepine, oxcarbazepine, phenobarbital, primidone, felbamate), only patients on non-enzyme inducing anti-epileptic drugs (NEIAED) or on no anti-epileptic drugs are eligible
Patient currently receiving treatment with any medications that have the potential to prolong the QT interval and cannot be either discontinued or switched to a different medication prior to starting study drug
Patients receiving any of the following medications are not eligible for study:\r\n* Anti-cancer therapy or investigational agents\r\n* Anti-coagulants (except for heparin to maintain the patency of central venous catheters)\r\n* Growth factors for white blood cell, red blood cell or platelet support\r\n* Aspirin (> 81 mg/day)\r\n* Non-steroidal anti-inflammatory drugs\r\n* Clopidogrel (Plavix), dipyridamole (Persantine), or any other drug that inhibits platelet functions\r\n* Anti-convulsants: patients on any anti-convulsant with the exception of VPA are eligible for study entry; it is STRONGLY RECCOMMENED that a neurology consult be obtained to enable discontinuation of all anticonvulsant other than VPA, whenever possible
Current use of or =< 4 weeks prior to registration of anti-androgens such as flutamide, estrogens, ketoconazole, finasteride, or megestrol acetate
All herbal medicines (e.g., St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 232, and continuing use, if applicable, will be reviewed by the principal investigator
Use of any known CYP2C8 substrates with a narrow therapeutic window is not allowed during the study and patients must come off 14 days prior to receiving the first dose of AMG 232
Use of any known CYP3A4 substrates with narrow therapeutic window (such as alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, sirolimus, or terfanide) within the 14 days prior to receiving the first dose of AMG 232; other medications (such as fentanyl and oxycodone) may be allowed per investigator’s assessment/evaluation
Patients requiring medications that are sensitive CYP2D6 substrates areCYP2D6 substrates with a narrow therapeutic index or are anti-arrhythmic drugs/drugs with QT-prolongation risks
Taking medications with QT prolongation risk or interval or inducing Torsade de pointes Additional exclusion criteria for PDR001/QBM076-
Patients requiring medications with narrow therapeutic index CYP3A4 substrates
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting treatment; granisetron may be administered, but antiemetics associated with QT prolongation (e.g., ondansetron) are not allowed
Prior medication:
No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years
Sexually active males unless they use a condom during intercourse while taking the drug and for 3 months after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
If a potential study patient is taking any of the medications in the categories described below, the investigator will assess and document the use of medications known or suspected to fall in the following medication categories:\r\n* Moderate/weak CYP3A inducers such as efavirenz and oxcarbazepine\r\n* CYP2C8 substrates such as thiazolidinediones (glitazones) and select statins (because of expected inhibition of the metabolism of CYP2C8 substrates) by venetoclax\r\n* CYP2C9 substrates such as tolbutamide (because of expected inhibition of the metabolism of CYP2C9 substrates by venetoclax; it is recommended to exclude CYP2C9 substrates with a narrow therapeutic index such as phenytoin
Patients requiring concomitant medications that are not able to be switched to a reasonable alternative
Current or recent (=< 10 days prior to randomization) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes, unless the patient has been on a stable dose of anticoagulants for at least 2 weeks at the time of randomization; Note: the use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or activated partial thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard of the institution) and the patient has been on a stable dose of anticoagulants >= 14 days at the time of randomization; prophylactic use of anticoagulants is allowed
Has neutropenia (IBD and steroid use not excluded)
Concomitant use of QT prolonging agents strongly associated with torsades de pointes is not permitted
Prior use of lenvatinib
The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also, treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication
Inclusion Criteria:\n\n          1. Has a diagnosis of secondary leg lymphedema, based on a positive lymphoscintigraphy\n             (LSG) study of the affected leg OR has a diagnosis of primary lymphedema not of\n             congenital onset affecting one or both lower limbs, based on positive LSG.\n\n          2. Swelling of at least 1 leg not completely reversed by leg elevation or compression.\n\n          3. Stage II or greater lymphedema, based on the International Society of Lymphology (ISL)\n             staging system.\n\n          4. Completion of a full course of complete decongestive therapy (CDT).\n\n          5. Stable limb volume (within 10% during screening for worse/affected leg) .\n\n          6. If patient has had a lymphatic vascularization procedure (lymphovenous bypass or lymph\n             node transfer) or liposuction for lymphedema in the affected limb, then procedure must\n             have been performed at least 1 year (12 months) prior to Screening AND affected limb\n             must be clinically stable over the 3 months prior to Screening AND significant\n             residual disease must be present.\n\n          7. Ambulatory status (use of a walking aid is permitted).\n\n          8. Agree to use a medically acceptable method of contraception, if the possibility of\n             conception exists.\n\n        Exclusion Criteria:\n\n        Exclusions Based on Lymphedema:\n\n          1. A diagnosis of primary lymphedema with congenital onset. Primary lymphedema is defined\n             as lymphedema with onset prior to or without an inciting event (e.g, surgery, trauma,\n             radiation)\n\n          2. Occurrence of significant lymphedema of another body part that is not the lower limb\n             (e.g, upper extremity, trunk, head and neck, genitalia).\n\n          3. Lymphedema involving all four limbs\n\n          4. Recent initiation of, or intention to initiate CDT or maintenance physiotherapy for\n             lymphedema.\n\n             Exclusions Based on Other Medical Conditions\n\n          5. Deep venous thrombosis in either lower limb or systemic anticoagulation within 6\n             months\n\n          6. Other medical condition that could lead to acute or chronic leg edema.\n\n          7. Other medical condition that could result in symptoms overlapping those of lymphedema\n             in the affected leg.\n\n          8. History of clotting disorder (hypercoagulable state).\n\n          9. Chronic (persistent) infection in either lower limb.\n\n         10. Cellulitis or other infection in either lower limb or use of antibiotics for\n             cellulitis within 3 months prior to screening.\n\n         11. Other unstable or severe medical condition requiring active management and/or likely\n             to decompensate/require active management within the next year\n\n         12. Current evidence of malignancy.\n\n         13. History of malignancy within the previous 3 years, except for nonmelanoma skin cancer\n             or cervical carcinoma in situ treated with curative intent.\n\n         14. Currently receiving chemotherapy or radiation therapy.\n\n         15. Life expectancy < 2 years for any reason.\n\n         16. Pregnancy or nursing.\n\n         17. Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening.\n\n             Exclusions Based on Concurrent Medication Use\n\n         18. Regular concurrent use or regular use within 6 months before screening of another\n             leukotriene pathway inhibitor.\n\n         19. Concurrent antibiotic use.\n\n         20. Concurrent use of any agent active on the sphingosine-1-phosphate (S1P) pathway.\n\n         21. Concurrent use of unapproved (including herbal) treatments for lymphedema.\n\n             Exclusions Based on Laboratory Values\n\n         22. Significant or chronic renal insufficiency or requires dialytic support.\n\n         23. Hepatic dysfunction.\n\n         24. Absolute neutrophil count <1500 mm3 at screening.\n\n         25. Hemoglobin concentration <9 g/dL at screening.
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
Patients currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug; NOTE: prohibited medications contains drugs that should be used with caution due to possible or conditional risk of Torsades de Pointes
Current use of a prohibited medication or planned use of any forbidden medications during treatment with GSK2820151.
Self-report Timeline Follow-Back (TLFB) indicating current marijuana use >= 4 days/week for >= 1 year
Motivated to change their marijuana use (>= 1 on a 10-point Likert-type scale)
Regular or sporadic use of nicotine cigarettes (> 1 cigarettes in the past 30 days)
Current use of exogenous hormones
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs
Throughout the study, male subject must use a condom if having sex with a pregnant woman.
Chronic use of steroid therapy.
Current use of drugs that are known to prolong the QT interval
Other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or anagrelide). Aspirin use at doses up to 325 milligrams (mg)/day is permitted.
Active alcoholism or use of recreational drug (evaluated by history taking)
Patients who are currently receiving treatment with agents that are known to cause QTc prolongation or inducing Torsade de Pointes in humans and are unable to discontinue or switch to an alternate medication
Patients requiring chronic use of nonsteroidal anti-inflammatory drugs (NSAIDS)
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited: a) other anti-cancer therapy while on study treatment, b) the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Willingness and ability to use an electronic diary.
Current use of clobetasol propionate
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
Previous exposure to either fluorouracil (5-FU) or capecitabine at a systemic dose except for use in concurrent chemoradiation
Patient may not be taking any drugs that prolong the QT/QTc interval; if patient is on any of these drugs, patient may enroll in the study if the drugs can be discontinued for at least 5 half-lives prior to the first dose of tosedostat and capecitabine
Any drugs or supplements that interfere with blood clotting can raise the risk of bleeding during treatment with bevacizumab. These drugs include vitamin E, non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), and naproxen (Aleve, Naprosyn), warfarin (Coumadin), ticlopidine (Ticlid), and clopidogrel (Plavix).These agents should be used with caution.
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment\r\n* Prophylactic use of bisphosphonates in patients without bone disease, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, cannabis, St. John’s wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\n* Raloxifene is allowed for patients taking it for bone health
The development of erythema multiforme if characterized by a desquamating rash while taking thalidomide or similar drugs
Prior use of lenalidomide if discontinued due to toxicity
Concomitant use of significant CYP3A4 inhibitors unless able to be switched to a non-CYP3A4 inhibiting medication\r\n* Caution should be used when administering study drugs to patients taking medications significantly metabolized by these enzymes; particular attention should be paid to patients receiving warfarin; patients should have coagulation parameters monitored regularly, and warfarin dose adjusted accordingly; if these drugs cannot be discontinued or replaced, enrollment may be allowed after discussion with MSK principle investigator (PI)
Subjects who are using prescription or OTC medications (including, for example, proton pump inhibitors, H2 antagonists or calcium carbonate) that reduce or neutralize gastric acidity within 5 half lives before the first dose of study drug. Use of these medications for supportive care after cycle 1 is permitted.
Concurrent use of agents that strongly inhibit or induce cytochrome P450 family 3, subfamily A (CYP3A) unless use is approved by the medical monitor
Concomitant use of additional anti-neoplastic agents will not be allowed in this study
Be non-smokers (no nicotine use within the last 5 years)
Current major depression or another major psychiatric disorder as described in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (use of central nervous system [CNS] active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months)
Use of any drugs with pro-cholinergic properties (e.g. donepezil)
Patients may not have the following co-morbid disease or concurrent illness:\r\n* Chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients may not use chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to first dose of investigational drug (exception: anti-diarrheal medications used to control symptoms from a medication that will be discontinued prior to study are allowed with a 7 day washout before study therapy, for example loperamide for erlotinib-associated diarrhea)\r\n* Known cirrhosis, defined as Child Pugh class A or higher liver disease\r\n* Other malignancy undergoing active treatment\r\n* Any other severe/uncontrolled inter-current illness or significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation
Patients may not be receiving the following medications at the time of first dose of investigational drug:\r\n* Pharmacotherapy for known hepatitis B or C, tuberculosis, or human immunodeficiency virus (HIV) \r\n* Any of the following enzyme inducing anti-epileptic medications (EIAEDs): phenytoin, carbamazepine, oxcarbazepine, phenobarbital\r\n* Other chemotherapy, hormonal therapy, immunotherapy, other investigational agents, or biologic agents for the treatment of cancer except for bisphosphonates or denosumab
Patient is taking a drug with known risk to promote QT prolongation and torsades de pointes
Patient is currently using herbal preparations or medications; participants should stop using herbal medications 7 days prior to the first dose of the study drug
Concurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken) of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogens)
Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting study drug)
Sexually active males must use a condom during intercourse while taking the drugs and for 16 weeks after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Participants may not be receiving any other investigational agents for 30 days prior to baseline evaluation and during the study intervention (which will be captured on the Concomitant Medications CRFs)
Any omega-3 fatty acids should not be taken for 30 days prior to baseline evaluation and during the study intervention; if participants are consuming any of these items and would like to participate in this study, then a 30-day washout period will be required; participants will be encouraged to limit their use of nonsteroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase 2 (COX-2) inhibitors (which will be captured on the Concomitant Medications CRFs) in favor of alternatives, such as acetaminophen; for those who take these medications on a regular basis, they will be suggested to maintain a constant dose
Patients that are on anticonvulsant medications should be switched, when possible, to a non-enzyme-inducing antiepileptic drug (non-EIAED); however, if that is not possible, they will not be excluded from the study
Patients are ineligible if they plan on regular use of nonsteroidal anti-inflammatory agents (NSAIDs) at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDS or higher dose aspirin are eligible and no wash out period is required
Pre-existing condition that warrants long-term corticosteroid use; physiologic replacement is not permitted
Concomitant use of medications that may alter pharmacokinetics of abiraterone (abiraterone acetate) or enzalutamide
Taking medications that are known to be associated with torsades de pointes
Use more than 3 g/day of acetaminophen
Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug; herbal medications include, but are not limited to St. John’s wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; fruits include the cytochrome P450 subfamily 3A (CYP3A) inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
Any prohibited medication
Women must not breast-feed while taking the study medications
Patients receiving certain medications and/or substances that are prohibited within stated wash-out periods
Other medications known to prolong QT interval should be discontinued and if not possible, patient is excluded from this study
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs
No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy; limited doses of systemic steroids to prevent intravenous (IV) contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed
Patients taking herbal supplements (St. John’s Wort, gingko balboa, etc.) should discontinue these supplements two weeks prior to study registration
Prior use of regorafenib or other anti VEGF drugs
Use of controlled schedule III controlled substances for cancer-related pain control
Concomitant therapy with immune-suppressants or chronic use of systemic corticosteroids
Prior use of regorafenib
Women taking medications for which interaction with simvastatin may result in increased levels of simvastatin are not eligible
Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
Subjects taking the following sensitive cytochrome P450 (CYP) 3A4 substrate medications are excluded from the study unless they can be transferred to other medications prior to enrolling: alfentanil, aprepitant, budesonide, buspirone, conivaptan, darifenacin, darunavir, dronedarone, eletriptan, eplerenone, felodipine, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, quetiapine, saquinavir, sildenafil, simvastatin, tolvaptan, tipranavir, triazolam, ticagrelor, vardenafil and/or the CYP2B6 substrates: bupropion, efavirenz.
Subjects taking the following P-glycoprotein (P-gp) transporter-sensitive substrate medications are excluded from the study unless they can be transferred to other medications prior to enrolling: aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, fexofenadine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, and tolvaptan.
Subjects taking medications that are known to prolong the QT interval (see Section 9.11.3).
The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
Prior or concomitant use of megestrol acetate for the treatment of hot flashes is allowed
Patients who are currently receiving treatment with medications with a known risk to prolong the QT interval or inducing torsades de pointes and the treatment cannot either be discontinued or switched to a different medication prior to study enrollment
Patients who have taken herbal medications and certain fruits within 7 days prior to study enrollment are not eligible; herbal medications include, but are not limited to, St John‘s wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, tangelos and ginseng; exclusionary fruits include the cytochrome P450 family 3, subfamily A (CYP3A) inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
No previous use of corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL; prior use of corticosteroids for reasons other than treatment of autoimmune complications is allowed
History of long-term use of corticosteroids or concurrent short-term use of corticosteroids is not allowed; short-term corticosteroid use must be discontinued at least 2 weeks prior to study treatment
Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization.
Current use of drugs that are known to prolong the QT interval
History of erythema nodosum, characterized by a desquamating rash while taking thalidomide or similar drugs
Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) AND are unable to discontinue this medication or switch to a different medication prior to beginning study treatment are not eligible for participation
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs in the past
Unwilling to use contraceptives while on study if relevant to patient
Need for any of the medications on the list of drugs to be used with caution or to be avoided
Use of herbal or alternative remedies that may affect hormonal status such as prostasol or PC-SPES
Written authorization for use and release of health and research study information (United States [US] sites only) has been obtained
Have a pre-existing condition that warrants long-term corticosteroid use; inhaled steroids are allowed
Receiving QT-prolonging drugs with a risk of causing torsades de pointes (TdP), unless ECG meets inclusion criteria on a stable dose of the drug and with discussion and agreement with the project clinician
COHORT A: Prior use of a 5 alpha reductase inhibitor is allowed (no limit on duration of use); however a two week washout is required
COHORT B: Prior use of a 5 alpha reductase inhibitor is allowed (no limit on duration of use); however a two week washout is required
Participants receiving a medication that has a known risk of QTc prolongation or is associated with torsades de pointes or any prohibited medications, concomitantly or within 14 days (28 days for levomethadyl) of enrollment
May be on cholesterol medications
Use of any of the following medications or procedures within the specified timeframe:
Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab General Medical Exclusion Criteria:
Male subject must use a condom, if having sex with a pregnant woman.
Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, and delavirdine)
Concomitant use of drugs that may cause a prolongation of the QT interval corrected by Fridericia's formula (QTcF) or inducing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug; if these drugs become medically necessary during study, they must be used with caution
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment (megestrol if used as an appetite stimulant is allowed)\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, yohimbe, saw palmetto, or ginseng)\r\n* Patients receiving strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Herbal preparations/medications
Throughout the study, patients must use a condom if having sex with a pregnant woman
Patients taking medications that may have adverse interactions with enzalutamide
Current use of prohibited medication(s) or requirement for prohibited medications during study as per the study protocol. Use of anticoagulants such as warfarin is permitted; however, international normalization ratio (INR) must be monitored according to local institutional practice.
Blood pressure < 150/90 at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to initiation of treatment
Use of any of the following medications or treatments within the noted time prior to leukapheresis:
Medications with a risk of causing Torsades de Pointes are not permitted; although concomitant treatment with corrected QT (QTc) prolonging agents is not strictly prohibited, these agents should be avoided whenever possible and an alternative non-QTc prolonging drug should be substituted if possible
Written Authorization for Use and Release of Health and Research Study Information (United States [US] sites only) has been obtained
Concomitant use of medications that may alter pharmacokinetics of enzalutamide
PART B: Concomitant use of medications known to be associated with torsades-de-pointes
Ongoing use of enzyme-inducing anti-epileptic agents (EIAEDs), unless 2 week washout has elapsed form last dose of EIAED
Patients must be at least 28 days from use of any mushroom supplements (examples: turkey tail, reishi, maitake, shiitake) and agree to withhold them for the entire study period (one year)
Subjects taking the following sensitive cytochrome P450 (CYP) substrate medications that have a narrow therapeutic range are excluded from the study unless they can be transferred to other medications within ?5 half-lives prior to dosing: paclitaxel (CYP2C8) warfarin, phenytoin (CYP2C9), S-mephenytoin (CYP2C19), thioridazine (CYP2D6), theophylline and tizanidine (CYP1A2).
Subjects taking the P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) transporter-sensitive substrates digoxin and rosuvastatin should be excluded from the study unless they can be transferred to other medications within ?5 half-lives prior to dosing.
Subjects taking medications that are known to prolong the QT interval unless they can be transferred to other medications within ?5 half-lives prior to dosing.
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
The use of the following medications are excluded:\r\n* Insulin or sulfonylureas within the past 3 months\r\n* Thyroid medication use unless on stable doses for at least the past 3 months\r\n* Medications that are approved for weight loss (e.g., lorcaserin, phentermine, orlistat) within the past 3 months\r\n* Medications that are likely to cause weight gain or prevent weight loss (e.g., selective serotonin reuptake inhibitors [SSRI's], serotonin-norepinephrine reuptake inhibitors [SNRI's], corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) unless on stable doses for the past 3 months; \r\n* Medications that may affect adipokine or inflammatory markers (e.g., metformin, glitazones, steroids, non-steroidal anti-inflammatory drug [NSAIDS], angiotensin-converting enzyme [ACE] inhibitors, beta blockers and statins) unless on stable doses >= 3 months prior to registration (if discontinued, a washout of 2 weeks from prior use is required); NOTE: No medication should be discontinued without the medical direction and guidance of the prescribing provider
Willing to discontinue all herbal preparations/medications at least 7 days prior to the first dose of study drug and throughout the study; these include, but are not limited to, St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng
Prior anthracycline use >=150 mg/m2
Excessive alcohol intake (more than 3 alcoholic beverages per day) should be avoided (occasional use is permitted)
Prior use of sorafenib
Current use of megestrol acetate (Use within 10 days of Day 1)
Prior use of any hypomethylating agent or cytarabine
Unwillingness to stop taking herbal supplements while on study
Initiation of strong antioxidant supplements during treatment, or ongoing use of supplements containing concentrated plant-derived polyphenols (pine bark, grape seed, green tea, milk thistle extracts; resveratrol; ellagic acid)
Use of any non-protocol vitamin D supplementation
Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug; herbal medications include, but are not limited to St. John’s wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; fruits include the cytochrome P450, family 3, subfamily A (CYP3A) inhibitors Seville oranges, grapefruit, pomelos, or exotic citrus fruits
Patients who have received herbal medications =< 2 weeks prior to study entry; herbal medications include, but are not limited to: St. John’s wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng
Current use of any of the drugs (prohibited concomitant medications)
Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 6 weeks prior to randomization
Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 6 weeks prior to randomization
Written Authorization for Use and Release of Health and Research Study Information has been obtained
Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Concomitant use of herbal medications (i.e. St. John’s wort, Kava, ephedra [ma huang], gingko biloba) at least 7 days prior to the first dose of study drug and throughout participation in the trial
Prior use of sorafenib, oxaliplatin, or fluorouracil (5FU)
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Prior use of lenalidomide if discontinued due to toxicity
Patients taking drugs leading to significant QTc prolongation unless able to be switched to non-QTc prolonging medication without risk of worsening underlying condition and meet all other inclusion criteria
Inability to withhold agents that may interact with hepatic cytochrome P450 enzymes (cytochrome P450 family 3, subfamily A, polypeptide 4 [CYP3A4]), or glutathione S-transferases involved in bortezomib and/or busulfan metabolism during day -5 through day +7; it is acceptable to use alternative non-interacting medications during this period, and then resume prior medications; importantly, no acetaminophen starting at HSCT admission, during conditioning chemotherapy and up to and including the stem cell infusion
Use of any prohibited concomitant medications within 30 days prior to cycle 1, day 1
Pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Any prior use of thalidomide or pomalidomide
Current use of a prohibited medication
Use of other prohibited medications within 5 half-lives or 14 days prior to the first dose of study drugs or requires any of these medications while receiving medication on this study
Subjects taking nucleoside analog medications such as those used as antiretroviral agents
Prior use of any chronic systemic glucocorticoids .
Use of any substance known to cause AME
Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either safely discontinued or switched to a different medication prior to study entry. (Please see www.azcert.org/medical-pros/drug-lists/printable-drug-list.cfm for a list of agents that prolong the QT interval.)
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
Prior use or participation in a clinical trial of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448), chemotherapy, or immunological agents (e.g., immune modulators, cytokines, vaccines, or antibody-delivered chemotherapy); the use of denosumab for bone metastasis is permitted
Current use of a prohibited medication while on dabrafenib
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Requiring any of the following concurrent treatment or medications:\r\n* Radiation therapy\r\n* Chemotherapy\r\n* Interferon (e.g. Intron-A®)\r\n* Allergy desensitization injections\r\n* Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)\r\n* Interleukins (e.g. Proleukin®)\r\n* Any investigational therapeutic medication
Willing and able to discontinue prohibited concomitant medications and/or treatments for CTCL during the study
Use more than 3 g/d of acetaminophen
Current or anticipated use of enzyme-inducing anti-epileptic drugs (EIAED)
Concomitant use of other anticancer (except for corticosteroids) or experimental agents
Use of enzyme-inducing anticonvulsants (EIACs); a minimum interval of 10 days between the last dose of EIAC and start of this therapy will be required for research participants who were previously receiving such medications
Dasatinib use prior to ASCT is allowed
Use of concomitant drugs that prolong QT/QTc interval are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient, but only if clinically indicated and must be fully documented.
Concomitant Medication and Treatment: \r\n* All allowed medications or treatments should be kept to a minimum and recorded; all questions regarding concomitant medications should be referred to the Investigator
Long term concurrent medications and/or treatments Not Allowed: \r\n* Corticosteroids, chemotherapy, cyclosporin A; short term (approximately 1 week) use of topical, low-dose or inhaled steroids may be allowed at the discretion of the investigator; injectables not allowed
Current use of a prohibited medication or requires any of these medications during treatment with lapatinib prior to study entry
History of erythema nodosum characterized by desquamating rash while taking thalidomide or similar drugs.
Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g. interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to study entry. NOTE: Recent or current use of inhaled steroids is not exclusionary. If subjects are prescribed a brief course of oral corticosteroids, the use should be limited to less than 7 days. Use of steroids before apheresis and immune assessment blood draws should be discouraged as it will affect white blood cell function.
Use of medications that are known to prolong cause QT prolongation
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol.
Current use of a prohibitive medication(s)
Current use of anticoagulants
Presence of active infection or systemic use of antimicrobials within 72 hours prior to the first injection
Concurrent use of known cytochrome P450 3A4 (CYP 3A4) inhibiting or activating medications
Regular use of vitamin D supplements >= 2,000 IU per day in the past year; use of supplemental vitamin D or supplements containing vitamin D beyond the protocol-prescribed study treatment is not allowed while enrolled on this clinical trial \r\n* In order to maintain blinding, vitamin D levels should not be routinely checked at screening or during the study by the treating investigator; vitamin D levels will be assayed only as part of the research blood samples collected during the study; if there are concerns related to a participant’s vitamin D status, the lead principal investigator should be contacted for further discussion
Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional ULN, corrected for albumin level if albumin is not within institutional limits of normal); the use of supplemental calcium is prohibited while on study
Regular use of thiazide diuretics (i.e., hydrochlorothiazide), which can lead to hypercalcemia, and unwillingness or inability to discontinue or switch to alternative anti-hypertensive agent
Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted
Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Any prior use of lenalidomide
Concomitant medications should be avoided (when possible) while on study
Patients requiring > 325 mg per day or non-steroidal anti-inflammatory medications known to inhibit platelet function; patients taking cyclooxygenase-2 (COX2) inhibitors are allowed to enroll
Willingness to forego concurrent use of supplements containing omega-3 fatty acids, corticosteroids, non-steroidal anti-inflammatory drugs or other FAP directed drug therapy.
Regular use of aspirin in excess of 700 mg per week.
Any prior use of lenalidomide.
Prior use of pazopanib or other agents targeting angiogenesis pathway (such as bevacizumab, sunitinib, or sorafenib) in the metastatic setting
Prior use of an investigational drug that targets VEGF or VEGF receptors
Any prohibited concomitant medications for therapy with afatinib or gefitinib
Concomitant use of drugs with a risk of prolonging the QT interval and/or causing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug; concomitant use of strong cytochrome P450 (CYP)3A4 inhibitors
Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol; concomitant use of corticosteroids is permitted as clinically indicated
Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of pazopanib will be determined following review of their cases by the Principal Investigator
Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin) are ineligible
Use of cord blood as the source of hematopoietic cells is not allowed.
Is on any specifically prohibited medication or requires any of these medications during treatment with pazopanib
Use of potassium wasting diuretics during study treatment
Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Current use of a prohibitive medication(s) as listed in Section 6.2. NOTE: Use of anticoagulants such as warfarin is permitted; however, the international normalization ratio (INR) must be monitored in accordance with local institutional practice.
Patients must not be concurrently taking other medications or supplements with known hormonal effects, including PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto; all other medications with possible anti-cancer effects must be discussed with the principal investigator (PI) prior to study entry
Current use of a prohibited medication or expected to require any of these medications during treatment with study treatment.
Concomitant use of bisphosphonates is allowed
E 18. Contraindications to the use of corticosteroid treatment.
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed; the use of denosumab [Xgeva] is permitted)
Intake of any herbal preparations or medications (e.g., including, but not limited to, Saint-Johns wort and ginkgo biloba) and dietary supplements within 7 days prior to first dose of study drug
Patients unable or unwilling to discontinue (and substitute if necessary) use of prohibited drugs for at least 30 days prior to day 1 of FOLFIRI initiation
Concomitant use of foscarnet, liposomal amphotericin B or aminoglycoside
Use of cidofovir for bladder instillation
Concurrent use of filgrastim (G-CSF) except for the short-term management of neutropenic infection; stable doses of erythropoietin stimulating agents or corticosteroids that were being administered prior to screening are allowed
Receiving, or planning to receive, any of the medications listed in the Prohibited Medications during conduct of the study
Able to take medications orally
Angina pectoris requiring antianginal medications
Patients require ongoing therapy with non-steroidal anti-inflammatory drugs (NSAIDs), intravenous (i.v.) vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less)
Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 3 months after stopping treatment
Using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
Patient developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Patient has any prior use of lenalidomide
Taking medications that are known to be associated with Torsades de Pointes
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or lenalidomide drugs
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Subject is receiving medication(s) that might affect immune function; use of H2 antagonists are prohibited as are all antihistamines five days before and five days after each injection of study vaccine; however, NSAIDS including COX-2 inhibitors, acetaminophen or aspirin are permitted
All subjects must agree to stop the use of all herbal medicines (e.g., St. John’s wort), and supplements, within the 10 days prior to receiving the first dose of AMG 232, and during the protocol AMG 232 treatment (weeks 1-5); subjects may renew the use of the above at week 6; standard adult multi-vitamin is allowed
All subjects must agree to stop the use of any known CYP3A4 substrates with narrow therapeutic window (such as alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, sirolimus, or terfanide; within the 14 days prior to receiving the first dose of AMG 232 and during protocol AMG 232 treatment (weeks 1-5); other medications (such as fentanyl and oxycodone) may be allowed per investigator’s assessment/evaluation
All subjects must agree to stop the use of any known CYP2C8 substrates with a narrow therapeutic window within the 14 days prior to receiving the first dose of AMG 232 and during protocol AMG 232 treatment (weeks 1-5)
All subjects are required to submit a list of medications consumed within 14 days prior to receiving the first dose of AMG232 and during the protocol AMG232 treatment (weeks 1-5)
Current use of drugs that are known to prolong the QT interval
Use of amifostine or pilocarpine before and during radiotherapy is not allowed
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Any prior use of lenalidomide
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity of pharmacokinetics (PK) of AZD2171 will be determined following review of their case by the principal investigator; efforts should be made to switch patients with brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications one week prior to starting therapy
Medications that inhibit platelet function and anticoagulants
Prior use of Herceptin (trastuzumab), and a taxane
More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped;
Patients receiving treatment with other antiepileptic medications will not be excluded. Vorinostat is not metabolized by cytochrome P450 3A4 (CYP 3A4). However, vorinostat may potentially suppress CYP 3A4 activity. Therefore, patients should preferably be treated with non-enzyme inducing anti-epileptic medications to avoid any potential interactions with vorinostat.
(8. continued) However, the use of non-enzyme inducing anti-epileptic medications is not mandatory. If enzyme-inducing antiepileptic drugs are used, monitoring of drug levels should be considered, as considered clinically appropriate by the treating physician.
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of E7389 Halichondrin analog will be determined following review of their case by the principal investigator
Patients will be excluded if there is a need to administer drugs that inhibit platelet function, such as aspirin or clopidogrel; for such medications a wash-out period of >= 7 days is required prior to starting dasatinib
Use of any experimental immunotherapy.
Undergoing stapled anastomosis with the use of an experimental or non-FDA approved stapler.
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (Note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\n** Note: for proliferative disease, hydroxyurea will be allowed during weeks 1 and 2 of cycle 1 of study; hydroxyurea may be started or the dose changed during that 2-week period if it is clinically indicated; if a subject not previously on a stable dose of hydroxyurea needs to begin hydroxyurea or a subject on a stable dose needs to have their dose increased during the first 2 weeks, the investigator will notify the clinical team that this has been initiated
Use of raloxifene for bone health is allowed
Patients must be at least 1 week from the last dose of complementary or alternative medications
Use of nasogastric or gastronomy (G)-tube administration
History of major psychiatric disorder including use of anti-depressive medications, mood stabilizers, or anti-psychotic drugs
Prior use of brentuximab vedotin
Use of prohibited medications:
Subjects currently receiving treatment with any medications that have the following potential properties and who cannot be either discontinued or switched to a different medication:
Current use of a prohibited medication or expected to require any of these medications during treatment with the investigational drug
Herbal preparations or over-the-counter supplements containing herbal ingredients (St. John’s wort, Estroven, blue cohosh) are prohibited during treatment and must be stopped within 24 hours (h) of first dose of dasatinib
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
Use of two forms of contraception with less than a 5% failure rate or abstinence by all transplanted participants for 18 months after the first dose of study therapy; for the first 60 days post-transplant, recipients should be encouraged to use nonhormonal contraceptives due to the potential adverse effect of hormones on bone\r\nmarrow engraftment
The need for treatment with medications with clinically relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422 (Appendix B).
Current use (or planned use during the treatment period) of other investigational agents, or biological, chemotherapy, radiation or other anti-tumor therapy
Receiving medication that prolongs QT interval ,with a risk of causing Torsades de Pointes (TdP), unless ECG meets inclusion criteria while on a stable dose of the medication
Previous use of interferon, ixazomib or bortezomib
Use of any antineoplastic treatment post-chemotherapy, including but not limited to aminoglutethimide, ketoconozole, abiraterone acetate, Rad-223, sipuleucel-T, or enzalutamide. Continuing steroids is permitted.
Patients taking other commercially available medications which may theoretically either stimulate or inhibit autophagy, which are calcitriol and chloroquine
Patients taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone
Patients must not have prior visual field changes from prior 4-aminoquinoline compound use
Current use of FWGE
Has a condition that requires the concomitant use of any of the protocol-excluded medications, supplements, or food products during the course of the study .
Use of any experimental immunotherapy.
Current use (within 10 days of day 1) of megestrol acetate.
Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug; herbal medications include, but are not limited to St. John’s Wort, Kava, and ephedra (ma huang), dehydroepiandrosterone (DHEA), gingko biloba, yohimbe, saw palmetto, and ginseng; fruits include the cytochrome P450, family 3, subfamily A (CYP3A) inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
Use of statin drugs or other medications known to associate with rhabdomyolysis; these drugs must be discontinued at enrollment
Prior use of regorafenib; subjects permanently withdrawn from study participation will not be allowed to re-enter study
Use of daily and/or chronic oral or ocular steroids. Individuals must be off daily steroids for at least 3 weeks prior to enrolling into the trial
Prior use of regorafenib
Sexually active males unless they use a condom during intercourse while taking the drug and for 3 months after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
A condition that is expected to require concomitant use of any medication listed as prohibited while on study.
Treatment with any medication that has a clinically relevant potential risk of prolonging the QT interval or inducing torsades de pointes that cannot be discontinued or switched to a different medication before starting study drug.
Treatment with any medication that has a clinically relevant potential risk of prolonging the QT interval or inducing torsades de pointes that cannot be discontinued or switched to a different medication before starting study drug.
Prior use of regorafenib
Participants requiring daily use of non-steroidal anti-inflammatory drugs (NSAIDs), with the exception of =< 81 mg aspirin per day; during study participation, acetaminophen is preferred for treatment of pain; the use of NSAIDs, as needed for pain, is discouraged
Taking any medication known to inhibit the CYP3A4 isozyme or any drugs that are CYP3A4 inducers (including phenytoin), or any drugs associated with torsades de pointes or known to prolong the QTc(f) interval within 2 weeks prior to Day 1 of treatment on study. A stable regimen of antidepressants of the SSRI class is allowed
Participants who take medications that are not recommended for concomitant use with their current antiretroviral regimen
Stage IIIB disease not amenable to surgery or curative intent. Note: It is permissible to use either AJCC Version 6.0 or the AJCC Version 7.0 staging system. For sites that use AJCC Version 7.0, T4M0 patients with other ipsilateral nodules and N0-N2 are still eligible.
Use of any prohibited concomitant medications (washout period of 1 week)
Current use of a prohibited medication per protocol or expected to require any of these medications during treatment with study drug.
have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000 mg daily).
Willing to refrain from the concurrent use of high-dose (200 mg or higher per day) of vitamins, antioxidants, Proscar, Avodart, and anti-inflammatory agents
Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization; or concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
Current use of drugs with known cardiotoxicity
Medications that are known to be associated with Torsades de Pointes
Receiving any medications or substances with risk of torsades de pointes; Note: medications or substances on the list “Drugs with Risk of Torsades de Pointes” are prohibited; medications or substances on the list “Drugs with Possible or Conditional Risk of Torsades de Pointes” may be used while on study with extreme caution and careful monitoring
History of allergies to sulfonamide, aspirin, any nonsteroidal anti-inflammatory drugs (NSAIDS), 5-FU or celecoxib
Use of aspirin is NOT an exclusion criterion as long as the daily dose does not exceed 325 mg daily; initiation of ADAPT therapy requires patient to discontinue aspirin for 18 months
Current use of systemic steroid medication
Patients taking any of the following drugs are excluded: inducers or inhibitors of CYP2C9, warfarin, aspirin, corticosteroids, or non-steroidal anti-inflammatory drugs (NSAIDs)
Use of drugs that have a risk of causing QT interval prolongation and/or have a known risk of causing Torsades de Pointes (TdP) before 14 days or the recommended 5 half-life.
Able to abstain from taking prohibited drugs, either prescription or non- prescription, during the treatment phase of the study
Planned use of any treatment for PTCL during the course of the study.
Caution should be used if patients are required to use a concomitant medication that can prolong the QT interval and efforts should be made to switch to a different medication before the patient begins treatment under an experimental arm
The eligibility of patients taking medications that are potent inducers or inhibitors of that enzyme will be determined following a review of their case by the principal investigator; every effort should be made to switch patients taking such agents or substances to other medications before they begin treatment with one of the experimental drug included in this protocol, particularly patients with gliomas or brain metastases who are taking enzyme-inducing anticonvulsant agents
For men receiving BCG: Agreement to remain abstinent (refrain from sexual intercourse) or use a condom
Drugs that are known to increase torsades de pointes should be avoided; patients must discontinue these medications prior to enrollment on study; selection of alternate concomitant medications with no or minimal torsades de pointes potential is recommended
Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs
Medicines with high probability to cause QT prolongation or torsades de pointes. Subjects on chronic medications in this category may enroll after discussion with the medical monitor if changing these medications are not in the best medical interest of the patient.
Eligibility of patients receiving any medications or substances known to affect or have the potential to affect the activity or pharmacokinetics of temsirolimus will be determined following review of their case by the Principal Investigator
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
Treatment with medications that are known to carry a risk of Torsades de Pointes
The participant is receiving chronic therapy with nonsteroidal anti-inflammatory drugs or other antiplatelet agents. Aspirin use at doses up to 325 mg/day is permitted.
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
Patient is taking a drug with a risk to promote QT prolongation and Torsades de Pointes.
Patient is currently using herbal preparations or medications. Patient should stop using herbal medications 7 days prior to the first dose of the study drug.
Previous use of mitoxantrone and etoposide combination therapy within the preceding 180 days of screening
Any active infection requiring the use of parenteral anti-microbial agents or that is > Grade 2;
Subjects must not have been taking any lithium or lithium containing medications within 90 days prior to study enrollment
Unable to receive medications by mouth
Concurrent medications associated with a risk of corrected QT (QTc) prolongation and/or torsades de pointes are not allowed; those medications listed as reported but lacking substantial evidence for causing QTc prolongation and torsades de pointes will be allowed, although if an alternative medication can be substituted, that would be preferable; for this study, a baseline electrocardiogram (EKG) will be performed and will be repeated during cycle 1 and then every 3 cycles while on treatment
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug.
Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM
Concurrent treatment with protocol-defined prohibited medications (refer to protocol for details)
Prior use of hydroxyurea or isolated doses of cytarabine for palliation (i.e., control of WBC) are allowed but should be discontinued at least 24 hrs prior to enrollment.
Patients currently taking medications with known rosuvastatin interactions including cyclosporine, gemfibrozil, lopinavir/ritonavir, atazanavir/ritonavir, coumarin anticoagulants, colchicine, fenofibrates, and niacin
Contraindications to the use of corticosteroid treatment.
Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), clopidogrel or any other drug whose goal is to inhibit platelet function
Subjects taking the following sensitive cytochrome P450 (CYP) substrate medications that have a narrow therapeutic range are excluded from the study unless they can be transferred to other medications prior to enrolling: paclitaxel (CYP2C8), warfarin, phenytoin (CYP2C9), S-mephenytoin (CYP2C19), thioridazine (CYP2D6), theophylline and tizanidine (CYP1A2)
Subjects taking the P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) transporter-sensitive substrates digoxin and rosuvastatin should be excluded from the study, unless they can be transferred to other medications prior to enrolling. study unless they can be transferred to other medications prior to enrolling
Subjects taking medications that are known to prolong the QT interval
Patients currently receiving any medication that has the potential to prolong the QT interval or induce Torsades de Pointes
Chemotherapy or other investigational anticancer therapeutic drugs within 1 week prior to study entry unless AEs have resolved and there is no interference with the assessment of efficacy or safety; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 12 hours before study entry. Patients with prior bone marrow or stem cell transplant, considered for inclusion, should be discussed with the medical monitor first.
A medical condition requiring use of pancreatic enzymes; daily, chronic, or regular use of proton pump inhibitors (PPIs); or histamine 2 (H2) receptor antagonists. Participants who intermittently use these medications, must meet the following criteria:
No use of PPIs within 5 days before the first dose of alisertib.
No use of H2 antagonist or pancreatic enzymes within 24 hours before the first dose of alisertib.
Requiring treatment with any of the prohibited concomitant medications
Male patients not willing to use a condom
Chronic daily treatment with NSAID (occasional use for the symptomatic relief of medical conditions, for example headache or fever is allowed)
Ongoing treatment with any drugs known to prolong the QTc interval, including anti-arrhythmic medications (stable regimen of antidepressants of the selective serotonin reuptake inhibitor (SSRI) class is allowed))
No concurrent use of statins (except for pravastatin, if absolutely necessary)
Any prohibited medication(s) or herbal preparation as described in the protocol or requires any of these medications during the study.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Unable to receive medications by mouth
Current use of a prohibited medication as described in the protocol.
Use of medications that have been linked to the occurrence of torsades de pointes\r\n* Patients will be eligible for the study if they discontinue any of the listed medications two weeks prior to registration and study enrollment\r\n* Stable regimen of antidepressants of the selective serotonin reuptake inhibitor (SSRI) class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline and fluoxetine)
Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
Sexually active males unless they use a condom during intercourse while taking the drug and for 60 days after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Patients taking the following medications may experience QT/QTc interval prolongation and are not eligible for the trial - most anti-arrhythmia drugs (incl. amiodarone), erythromycin, quinolone antibiotics, ketoconazole, Zithromax, and phenothiazine and will be denied enrollment in the study. The possible interactions of these drugs and DM-CHOC-PEN have not been established. Patients receiving these drug will only be eligible if they discontinue the drugs and have an acceptable ECG.
Concomitant use of biological agents including growth factors. Exception: 3- to 6-patient breast cancer cohort enrolled to explore the use of prophylactic growth-factor support of a 1.4 mg/m2 dose of eribulin.
Current use of a prohibited medication
Current or expected use of a prohibited medication, including enzyme-inducing antiepileptic drugs (EIAEDs) during treatment with GSK2118436.
Subjects who are not currently taking prohibited medication
Use of medications that increase serum levels of phosphorus and/or calcium
Is able to take medications orally
Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Inclusion Criteria:\n\n        18 years;\n\n          -  Clinical confirmation of adrenocortical carcinoma that is locally advanced or\n             metastatic and not amendable to surgical resection;\n\n          -  Failed or declined mitotane (adjuvant or therapeutic) therapy or a platinum-based\n             chemotherapy regimen;\n\n          -  Able to understand and comply with the protocol requirements;\n\n          -  Willing and able to provide informed consent.\n\n        Exclusion Criteria:\n\n          -  Mitotane level > 5\n\n          -  Use of contraindicated concomitant medications\n\n          -  Unstable medical condition that, in the judgment of the investigator, could interfere\n             with study procedures or data interpretation.
The need for treatment with medications with clinically relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
Any prohibited medication(s) as described in protocol
Any known contraindications to the use of a required comedication (gemcitabine or nab-paclitaxel).
Written authorization for use and release of health and research study information has been obtained
Contraindications to steroid use
Patients who are on daily proton pump inhibitor therapy must be able to discontinue use or only require use of antacid or hydrogen (H2) antagonist intermittently; patients who require daily administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes are not eligible; intermittent uses of antacids or H2 antagonists are allowed
Use of a concomitant medication that can prolong the QT interval is strongly discouraged and patients should be advised to discontinue use of these medications during the study period and alternatives selected when indicated
Patients on medications with the potential for significant interaction with orteronel; patients may be rescreened and considered eligible for this protocol 7 days after they discontinue these medications; specific considerations include:\r\n* Medications with a known risk for causing torsades des pointes\r\n* Medications with a potential for increasing the QTc\r\n* Medications should be reviewed with attention to:\r\n** Beta-blockers \r\n** Diuretics \r\n** Anti-coagulants\r\n** These medications will not exclude patients from study, but should be brought to the attention of both the treating physician and PI with consideration for closer monitoring, to be determined clinically
Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) or antiandrogen (i.e. flutamide, bicalutamide) within 6 weeks of day 1 of protocol therapy
Use of medications or herbal supplements which are known to potentially lower serum PSA within 6 weeks of day 1 of protocol therapy
Use of other medications that may potentially interact with itraconazole within 1 week of study entry
Any prohibited medication
Concomitant use of prohibited therapy (specified in protocol)
Current or recent (within 6-months) use of lipid-lowering medication
Written authorization for use and release of health and research study information has been obtained
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the principal investigator
Participants taking medications known to have a significant risk of causing QTc prolongation and Torsades de Pointes
Taking other excluded medications
Taking herbal medications and certain fruits and juices within 7 days prior to starting study drug; herbal medications include, but are not limited to St. John’s wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; fruits and juice include the cytochrome P450 3A4 (CYP3A) inhibitors: Seville oranges, grapefruit, and pomelos
Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved or returned to baseline
No known sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs)
Active use of an epidural catheter
Subjects taking medications known to increase risk of Torsades de Pointes
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
Willing to discontinue use of medications that inhibit platelet function >= 10 days prior to registration; aspirin at doses greater than 325 mg/day must be discontinued >= 10 days prior to registration and avoided through the study; note: nonsteroidal anti-inflammatory drug (NSAID) medications are recommended in place of aspirin; if NSAIDs or aspirin are used, histamine (H)-2 blockers and proton pump inhibitor (PPI) medications are recommended
The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
Patients must not be receiving other investigational medications (covered under another IND) while on study.
Patients must not be receiving anti-hypertensive medications at time of study entry.
Current use of or anticipated requirement during the study of prohibited medication(s) (any investigational drug(s), Other anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormone therapy other than for replacement), AR antagonists (e.g., bicalutamide, flutamide, nilutamide), 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), Androgens (e.g., testosterone, dihydroepiandrosterone), Herbal medication(s) that may affect PSA levels (e.g., saw palmetto), Other herbal medications including, but not limited to: St. John's wort, kava, ephedra (ma huang), gingko biloba, yohimbe and ginseng)
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Anti-platelet drugs within 4 weeks prior to the first dose of study drug. Anti-platelet drugs are defined as any agent or combination of agents with clinically proven anti-thrombotic activity administered by any route with the purpose of affecting blood clotting ability of the subject.
Any prohibited medication(s), currently used or expected to be required.
Any medications for treatment of left ventricular systolic dysfunction.
Prior use of regorafenib
Prior use of sorafenib
Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of cabozantinib will be determined following review of their cases by the principal investigator; patients who are taking enzyme-inducing anticonvulsant agents are not eligible
Current use of a prohibited medication or herbal preparation or requires any of these medications during the study.
While not an exclusion criterion, unless considered clinically indicated, patients should avoid taking other additional non-study medications that may interfere with the study medication; in particular, patients should avoid medications that are known to either induce or inhibit the activity of hepatic microsomal isoenzymes CYP1A2, CYP2C19 and CYP3A4
Current use of alpha-adrenergic receptor blockers For Combination Arm only:
Current use of medications with smoking cessation efficacy
Written authorization for use and release of health and research study information has been obtained
Patients with a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Receiving any medication that has documented data or is generally accepted as having increased risk of QT prolongation and/or Torsades de Pointes
Concomitant medications that are known inducers of CYP.
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Use more than 3 g/d of acetaminophen
Regular use of anti-inflammatory agents, with the exception of a baby aspirin regimen per principal investigator's (PI's) discretion
Taking medications known to increase risk of Torsades De Pointes (an abnormal heart rhythm)
Concurrent use of antiarrhythmics or contraindicated medications (including, but not limited to, cisapride, mesoridazine, pimozide, posaconazole, sparfloxacin, thioridazine)
Patients receiving herbal preparations/medications
Must not be on any prohibited medications.
Taking medications known to increase risk of Torsades De Pointes
As ketoconazole may inhibit paclitaxel metabolism, patients receiving ketoconazole for any treatment indication are ineligible; patients receiving any other medications or substances that are inhibitors or inducers of cytochrome P450 (CYP450) enzymes will be eligible; however, use all such medications or substances must be documented in the Case Report Forms
Concurrent medication that may cause QTc prolongation or induce Torsades de Pointes
Subjects who are known or suspected to be hypersensitive to any component of the study medications.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
Patients taking medications known to cause prolongation of the QT interval and associated with torsades de points; patients receiving drugs that are “possibly” or have a “conditional” risk may be entered
Use of any prohibited medications within 14 days of the first dose of study medication
patients receiving therapy with any medications with a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
Current use of a prohibited medication or requires any of these medications during treatment with study drug.
Receiving concurrent treatment with prohibited medications (refer to Table 1 for details on prohibited medications); Examples include: ampicillin, antacids, cimetidine, cyclosporine, kaolin, magnesium trisilicate, coumarin-type anticoagulants, macrolide antibiotics (e.g., clarithromycin, isoniazid, and erythromycin), anti-HIV agents (e.g., ritonavir and delavirdine), antidepressants (e.g. fluoxetine and fluvoxamine), calcium channel blockers (e.g. verapamil and diltiazem), steroids and their modulators (e.g., gestodene, raloxifene, and mifepristone), and several herbal and dietary components (e.g. bergamottin and glabridin).
Patients must not have retinal or visual field changes from prior 4-aminoquinoline compound use
The subject is unable or unwilling to stop taking vitamins, herbal remedy, or nonprescription medications
Participants must not receive concomitant medications known to inhibit platelet function or known to selectively inhibit cyclooxygenase-2 (COX-2) activity (i.e., all antipyretic and anti-inflammatory medications except acetaminophen)
Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several days
Currently receiving treatment with any medications listed on the prohibited medication listed in the protocol
Must not be receiving tacrolimus or cyclosporine; use of H2 antagonists such as ranitidine, cimetidine and proton pump blockers such as omeprazole are permissible only in conjunction with corticosteroids in the setting of increased intracranial pressure or for spinal cord compression, as these drugs interfere with cytochrome P450 3A4 (CYP3A4); if patients are given such drugs, they must be taken at least 4 hours after intake of everolimus
Use of H2 antagonists such as ranitidine, cimetidine and proton pump blockers such as omeprazole are permissible only in conjunction with corticosteroids in the setting of increased intracranial pressure or for spinal cord compression, as these drugs interfere with CYP3A4; if patients are given such drugs, they must be taken at least 4 hours after intake of everolimus
Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial
Patients using medications that have a relative risk of prolonging the QT interval
Chemotherapy or other investigational anticancer therapeutic drugs within 1 week prior to study entry. AEs from prior therapy must have resolved or stabilized so that there is no interference with the assessment of efficacy or safety; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 12 hours before study entry. Patients with prior bone marrow or stem cell transplant, considered for inclusion, should be discussed with the medical monitor first.
Docetaxel is a CYP3A4 substrate and caution should be taken with its use and any drugs known to interact with it; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
Patients may not be receiving any medications that are known to prolong QT interval unless reviewed and approved by the principal investigator (PI)
Patients currently taking drugs that are generally accepted to have a risk of causing torsades de pointes (unless these can be changed to acceptable alternatives)
The intermittent use of proton-pump inhibitors (PPI), H2-antagonists and antacids (including carafate) is only allowed within these guidelines:\r\n* PPI until day (D)-5 prior to the first dose of alisertib and prohibited for the duration of the study,\r\n* H2 antagonists until D-1 and after the dosing of alisertib is done,\r\n* Antacid formulations until 2 hours before dosing and after 2 hours following dosing
Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
Known history of QT/QTc prolongation or torsades de pointes (TdP); patients who are currently receiving treatment with medication with a known risk to prolong the QT interval or inducing torsades de pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drugs
Unable or unwilling to discontinue use of prohibited medications for at least 28 days prior to the first dose of topotecan/pazopanib and for the duration of the study
Prior use of regorafenib
Receiving any medications that prolong the corrected QT (QTc) and have a known risk for Torsades de pointes; note: providers should use caution with drugs with possible increased risk for Torsades de pointes; patient will be eligible if they can be taken off these medications prior to initiation of therapy and no less than 4 half-life of the medication
Sexually active males unless they use a condom during intercourse while taking the drug and for 8 weeks after stopping treatment and should not father a child in this period; a condom is required to be used also by vasectomized men
Patients taking prohibited medication listed in the protocol
Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug; herbal medications include, but are not limited to St. John’s wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; fruits include the cytochrome P450, family 3, subfamily A (CYP3A) inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
Patients must not be currently taking (or have taken in the past 6 months) medication for active, chronic conditions, including rheumatoid arthritis, carpal tunnel syndrome, tenosynovitis, systemic lupus erythematosus, gout, fibromyalgia, or severe osteoarthritis involving the hands, wrists, hips, knees, feet or ankles; this includes analgesic medications or medications being taken with the purpose of treating pain or that may have an effect on pain (e.g. anti-depressants for help with pain or neuropathy, corticosteroid shots for arthritis); (Note: patients taking daily low dose aspirin are allowed to participate in this trial)
No past or current use of mixed opioid agonist/opioid antagonists or other opioid antagonists
Patients must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration; current use of opioids (at the time of registration) and/or later during the course of the study is permitted but not required
Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (< 7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study
Use of drugs metabolized by CYP2D6; these are called CYP2D6 substrates
Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs after chronic use
Be taking anticholinergic medications
Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks
Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs are not allowed; for patients who have used these medications they must not have used them within 4 weeks prior to registration
Any change in psychotropic medications within the last 30 days
Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
Parent/caregiver and patient (if 12 years and older) must be willing to use a cellular telephone to receive medication reminders via text messaging during study period
Patients must not be currently taking or planning to take during study treatment the following medications:\r\n* B2 agonists\r\n* Bosutinib\r\n* Ceritinib\r\n* Floctafenine\r\n* Methacholine\r\n* Pazopanib\r\n* Rivastigmine\r\n* Vincristine\r\n* Silodosin
Sites must seek additional patient consent for the future use of specimens
Current use (previous 30 days) of a tobacco dependence treatment including bupropion, varenicline, and nicotine replacement because the person is trying to quit; use of bupropion for depression does not exclude the patient from participating; the occasional use of tobacco dependence treatment (e.g., nicotine replacement therapy [NRT]) to avoid using tobacco in public spaces is not considered to be an exclusion criteria
Individuals who use e-cigarettes and who are not smoking cigarettes; dual users (those who use both e-cigarettes and cigarettes) will be included in the trial
Current use of tobacco cessation medications
Use of bolus is permitted, but not required
Any change in psychotropic medications in past 30 days
Able to use and read a smartphone (iPhone or Android)
Patients who take long acting opioid medication use
Use of any of the following medications within the past 6 months: clarithromycin, telithromycin, chloramphenicol, itraconazole, nefazodone, cobicistat
Participants receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 are ineligible; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Use of toremifene
The use of growth factors other than erythropoiesis stimulating agents or G-CSF (filgrastim) (Neupogen or Neulasta) during the study period
Have basic proficiency in the use of a computer, including word processing and email
Caregiver is deaf or has significant hearing impairment and thus cannot use the telephone
Megestrol use at the time of study enrollment.
Any expected corticosteroid use during study enrollment at higher doses than will be used in this study.
If taking anti-neuropathy medications, they are on a stable regimen (no change in 3 months)
Previous use of light therapy to alleviate fatigue or depressive symptoms
If taking anti-neuropathy medications, they are on a stable regimen (no change in 3 months)
Must use a condom if having sex with a pregnant woman
Must use a condom if having sex with a pregnant woman
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Current treatment with medications known to prolong the QT interval Stage I:
Exogenous sex steroid use within 4 weeks prior to core needle biopsy
Current users of potent inhibitors of tamoxifen metabolism must be able to discontinue their use and switch to an alternative medication for the duration of participation, under the advice of their physician; if the physician feels that an alternative medication is not appropriate for the subject and the current medication is medically necessary, the subject will not be eligible; the drugs are listed below; many of these are not in clinical use at the moment; bupropion, celecoxib, chlorpheniramine, chlorpromazine, cimetidine, citalopram, clemastine, clomipramine, clozapine, cocaine, delavirdine, desipramine, diphenhydramine, doxepin, duloxetine, escitalopram, fluoxetine, haloperidol, halofantrine, hydroxyzine, imipramine, isoniazid, ketoconazole, methadone, methimazole, mibefradil, miconazole, nicardipine, paroxetine, pergolide, perphenazine, pioglitazone, pyrimethamine, quinidine, quinine, ranitidine, ritonavir, ropinirole, sertraline, terbinafine, thioridazine, ticlopidine, tranylcypromine, trazodone, tripelennamine
Medications or supplements that are known to be moderate reversible inhibitors of CYP3A within 5 times the inhibitor half-life (if a reasonable half-life estimate is known) or within 7 days (if a reasonable half-life estimate is unknown) before the first dose of study drugs. In general, the use of these agents is not permitted during the study for this combination except in cases in which an AE must be managed. See a list of nonexhaustive moderate CYP3A reversible inhibitors based on the US FDA Draft DDI Guidance.
Active and current use of illegal recreational drugs
Patients may not use natural herbal products or other “folk remedies” while participating in this study; herbal medications include, but are not limited to St. John’s wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng
Concomitant use of medications that may alter pharmacokinetics of abiraterone or apalutamide
Planned use of post-HCT cyclophosphamide for GVHD prophylaxis
In the critical care unit, or use of mechanical ventilation or use of renal replacement therapy at any time post HCT and prior to administration of ibrutinib
Patients with previous pain disorders or drug abuse requiring chronic narcotic use
Patients currently receiving anti-convulsants (such as gabapentinoids, e.g. gabapentin (Neurontin) or pregabalin (Lyrica) will be tapered off these medications over 7 days; the study team will provide instructions on how to do this
Concurrent use of monoamine oxidase inhibiting (MAOI) medication.
May use adjuvant endocrine therapy if use will be continued for duration of study intervention
Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter (e.g., Benadryl, Unisom) medications that can affect sleep during the study period
Current (weekly) use of cannabis
Subjects with a history of substance use disorder other than nicotine, such an opiate use disorder
Patients must not use topical steroids (e.g., hydrocortisone). Topical over-the-counter antibiotics (e.g., Neosporin) and skin protectants (e.g., Vaseline, Aquaphor) for local skin fissures on hands and feet.\r\n* Note: Patients are allowed to use topical medications on other body parts, besides the hands and feet, but must use qtips or gloves for application.
History of chronic narcotic use, defined as 30 days or more of preoperative daily narcotic use, measured from the date of surgery
PHASE 1 & 2: Own and use a smartphone or be willing to use a smartphone
Previous use of light therapy to alleviate fatigue or depressive symptoms
Use of non-steroidal anti-inflammatory drugs and aspirin is allowed but must be tracked
Other exclusion criteria include: illicit drug use, shift work, current dieting, excessive regular use of alcohol (more than two 5 ounce glasses of wine or equivalents/day) or a history of binge drinking (more than 7 drinks/24 hour period) within the last 6 months
Baseline erectile dysfunction, as defined by the use of medications or devices to assist erection, lack of baseline erections, or a SHIM/IIEF-2 21 or lower, which is collected as part of routine care.
Use of the following medications for seven days prior to and during study participation:\r\n* Stimulant medications\r\n* Sleep medications\r\n* Carbamazepine/Tegratol\r\n* Cough/cold medicines (e.g. Dextromethorphan, Triaminic, Robitussin, Vics Formula 44)\r\n* Flunarizine/Sibelium\r\n* Propnolol/Inderal\r\n* Sulpiride\r\n* Pergolide\r\n* Rivastigmine/Exelon\r\n* Carbidopa/levodopa or levodopa\r\n* Ropinirole/Requip\r\n* Nicotine patch
Use of narcotic pain medication, benzodiazepines, or illicit drugs for seven days prior to and during study participation
Candidate for use of laryngeal mask airway (LMA)
Subjects who have had emesis or required antiemetics in the 48 hours prior to starting the BEAM conditioning regimen; also patients required to take antipsychotics, appetite stimulants, or other medications with antiemetic effects will be excluded if those medications cannot be replaced by therapeutic equivalents
Pre-existing pain in the axilla affecting ability to use extremity for activities of daily living or requiring medication for treatment
Patient is being treated with oxymetazoline for allergic rhinitis or has a disorder or current medication use likely to adversely affect normal functioning of the nasal mucosa
Self ambulatory and without use of assistive walking devices
Is not self ambulatory and relies on the use of assistive walking devices
Expected to use other 5HT3 antagonists or NK1 antagonists during the study
Patients on drugs that may prolong the PR or QRS interval durations, such as any of the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided (e.g. flecainide, procainamide, propafenone, quinidine)
Do not have cognitive or visual impairments that would preclude use of the app
Patients who have a history of gastrointestinal dysmotility or functional gastroparesis, including diabetic gastroparesis, central and peripheral nervous system disorders, renal failure, medication side effects, including chronic dependence of promotility agents, anticholinergic antispasmodic agents, or daily narcotic use
Prior tamoxifen use is allowed
Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
Subjects receiving antidepressants, mood stabilizers, antipsychotic medications or benzodiazepines or drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded or at the PI’s discretion
Any use of an assisted walking device
EXCLUSION - STUDY 1: Taking medications unrelated to cancer treatment that may affect balance and gait
Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep (e.g., Benadryl, Unisom) during the study period
Patients on chronic pain medications (ie. chronic = more than once every two days for greater than 2 weeks) excluding aspirin, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs)
Patient has taken the anti-emetic agents within the last 48 hours prior to the start of treatment with study drug: (1) 5-hydroxytryptamine (HT)3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.); palonosetron is not permitted within 7 days prior to administration of investigational product; (2) phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.); (3) benzamides (metoclopramide, alizapride, etc.); (4) domperidone; (5) cannabinoids; (6) neurokinin (NK)1 antagonist (aprepitant); (7) benzodiazepines (lorazepam, alprazolam, etc); (8) herbal medications or preparations in doses designed to ameliorate nausea or emesis
Are willing and able to use a smartphone or tablet comfortably
As per self-report, is a regular smoker (daily use)
Consumption of dietary supplements or medications such as steroids that could affect metabolism
Regular use of narcotics
Knowledge of the internet and how to use web-based programs
Patients who are taking any antipsychotic medications
Patients with a history of documented anaphylaxis or contraindication to any of the study medications or standardized intra-operative medications; these include Dilaudid, fentanyl, and bupivacaine
Evidence of accessory respiratory muscle use with breathing
Airway or facial trauma that would hinder the use of a NIPPV mask
Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists
Medication exclusions will include steroids as well as statins and other medications with anti-inflammatory actions
Chronic excessive use of psycho-pharmaceuticals, alcohol, illicit drugs, or narcotics
Use of systemic steroids, or other pharmacological agents such as methylphenidate for cancer-related fatigue
Taking daily nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, for chronic conditions
Has another painful condition requiring chronic use of opioid analgesic, gabapentin, or pregabalin
Use of homeopathic medications or probiotics that may impact gut microbiota
Non-compliant to medications
Patients must agree not to use any additional estrogen during the five year study period; however, use of non-estrogen containing lubricants prior to sexual intercourse, or otherwise, is allowed
Use of any exogenous estrogen within the preceding four weeks
Planning on starting or stopping any chronic supplements or medications within six weeks prior to or throughout the study period
Use of concomitant medications that substantially increase seizure risk; such drugs could include neuroleptics (ex. haloperidol, droperidol), clozapine, tricyclic antidepressants (ex. amoxapine, clomipramine), bupropion (particularly the immediate release -IR- formulation) donepezil, psychostimulants (ex. methylphenidate), theophylline and/or other drugs that reduce the seizure threshold; for individuals on any of these medicines, a study clinician will evaluate the drugs and doses to determine the risks and benefits; these will then be discussed with the individual's Primary Care Physician to determine if the individual should be excluded from the study
Patients with history of epilepsy, brain damage, use of anti-convulsants for seizure prevention, concurrently using ketamine, symptomatic brain metastases; note: anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable dose
Currently on gabapentin or pregabalin; note: (all patients on these medications will be weaned off of them prior to study initiation; the study team will provide instructions on how to do this)
Current use of insulin or sulfonylureads for glycemic control, or history of ketoacidosis
Use of Erbitux
Smoking cessation treatment use in past 30 days
Non-cigarette tobacco use in the past 30 days
Concomitant use of aspirin or non-steroidal anti-inflammatory drugs
Refusing to use contraception up to 90 days post-HCT
Patients who are taking any antipsychotic medications.
Chronic oral or intravenous systemic steroid use (defined as being used on a regular basis or who have a problem that has required ongoing use of steroids in the last 180 days for greater than 7 days)
Use of full anticoagulant doses of coumadin or heparin (exception: 1 mg/day of coumadin for preventing catheter clots is allowed)
Patients who are on medications for chronic pain
Pre-existing active or untreated immunodeficiency disorder and/or chronic use of systemic steroids
Patients with chronic pain syndrome or requiring/using chronic pain medications
Current use of antipsychotics
Use of type III antiarrhythmics (e.g. amiodarone)
Participants receiving any medications or antibiotics to treat Clostridium difficile infection prior to the initiation of the study will be ineligible for this study
Planned medications from the time of HCT to day 70 post-HCT:\r\n* Live attenuated vaccines\r\n* Medically indicated subunit (Engerix-B for HBV; Gardasil for human papilloma virus [HPV]) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections)\r\n* Allergy treatment with antigens injections\r\n* Alemtuzumab or any equivalent in vivo T-cell depleting agent; this includes anti-thymocyte globulin (ATG) and post-transplant cyclophosphamide\r\n* Antiviral medications with known therapeutic effects against CMV such as ganciclovir (GCV)/valine (VAL), foscarnet (FOS), cidofovir, hexadecyloxypropyl-cidofovir (CMX-001) and maribavir; acyclovir has no therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV)\r\n* Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment\r\n* Other investigational product - concurrent enrollment in other clinical trials using an investigational product is prohibited\r\n* Other medications that might interfere with the evaluation of the investigational product
Use of over the counter steroid hormonal supplements
Use of n-3 fatty acids or high dose antioxidant supplements other than what is provided in the trial
Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours prior to day 1 of the study
Patients on medications that prolong QT interval, per principal investigator (PI) discretion
Use the internet on a regular basis
Glucocorticoid use is allowed
Change in pain medications/sleeping medications/anxiety medications/antiemetics during the trial
Use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of randomization
Use of select cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6) inhibitor medications
Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
Current or planned use of cyclosporine, anticoagulants, insulin, oral or injectable vitamin D doses over 4,000 IU/day, or tamoxifen
Current use of (other N-methyl D-aspartate [NMDA] antagonists) amantadine, ketamine, or dextromethorphan
Caregivers may or may not be receiving pharmacotherapy for depressive symptoms (type, use, and length of use will be treated as a potential confounding variable)
Currently receiving gabapentin or pregabalin and not willing to be weaned off of these medications prior to Scrambler therapy initiation\r\n* Note: it is OK to continue these medications in patients who are receiving TENS
Currently receiving anti-convulsants (such as gabapentinoids, e.g. gabapentin [Neurontin] or pregabalin [Lyrica]); all patients on these medications will be weaned off them prior to study initiation
History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization; mild depression or stable anti-depressants, and anti-seizure medications are acceptable; anti-anxiety medications may be acceptable
Current alcohol over-use as defined by currently consuming 4 drinks or more per day or binge drinking (6 or more drinks in one night) within the past week
Prior use of oxybutynin during the period in which patient has had hot flashes
Patients on pain medications (non-opioids), including nonsteroidal anti-inflammatory drugs (NSAIDS) and acetaminophen, may be enrolled as long as they have been using it chronically, at least more than 2 weeks
Prior use of regorafenib
Current use of a statin
Diagnosis of cardiovascular disease (CVD) with or without current statin use
Current use of a wearable PAM device as defined by use of PAM device in the last 6 months
Currently on 2 or more antidepressant or anti-anxiety therapies for mood disturbance of any kind; past use is allowed, just not current use
Individuals with a current substance use disorder will also be excluded
Patients who are on regular medications which will induce xerostomia (tricyclic antidepressants, antihistamines with anticholinergic effects)
Illicit drug use (excluding recreational marijuana)
Chronic gabapentin, or the similar drug pregabalin, use
Chronic narcotic use (daily or near daily use for > 90 days)
Anti-inflammatory medications (e.g. statins, cholesterol medication)
Currently on stimulants or other medications intended to treat cognitive impairment
Patient requires regular use of beta blockers or calcium channel blockers
Use of any medication that would interfere with the study's initial blood tests, including insulin or insulin secretagogues, corticosteroids, daily use of nonsteroidal antiinflammatory drugs (NSAIDs) (except aspirin at no more than 81 mg/day) within 7 days of the initial study blood test
Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids
If taking more than 1000 mg/day of elemental calcium, must be willing and able to discontinue or reduce their calcium use and/or use non-calcium based therapies for the duration of the study
No use of any anti-arrhythmic medication (except for beta-blockers and calcium channel blockers) including intravenous lidocaine, linezolid, ipratropium, or medications with anti-cholinergic potency (including neostigmine, a tricyclic antidepressant or a monoamine oxidase inhibitor) within 2 weeks prior to registration
No current use of glutamine or sucralfate powders at the time of registration (no washout required)
Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
Need for postoperative medications that could interfere with bone healing of the implant, such as steroids, (but not including low-dose aspirin or routine perioperative antiinflammatory drugs)
Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.
Patients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medications
Patients concurrently taking the following drugs are excluded: antioxidants, herbal or other alternative therapy medications, vitamin supplements (especially vitamins A, C, and E) other than at standard multivitamin doses, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, and amiodarone. If the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study (screening visit) one week or 5-half lives of the drug in question, whichever is the longer, after the discontinuation. For patients requiring any of these medications, entry is permissible only with permission from the medical monitor.
Ongoing use of anticoagulant therapy other than aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) that cannot be stopped for surgical procedures
Chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. Aspirin at doses up to 100 milligrams/day is permitted.
Participants who have used opioid-containing medications (including cough/cold medications containing codeine and/or antidiarrheals containing loperamide) in the past 2 weeks, or who are expected to require opioid-containing medications within the duration of the treatment period
Participants using other contraindicated medications (thioridazine, yohimbine)
Patients who are currently on stable prescription medications or dietary supplements for CIPN and still symptomatic as defined above will be allowed to participate in the study; related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12
Patient-reported cigarette use within the past 30 days
Anticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after receiving auranofin
No restrictions regarding use of other investigational agents
Patients who are taking medications (including minocycline) or have conditions that potentially preclude use of the study medication or intervention as determined by the treating physician
Caregivers: Willingness to use a smartphone
Caregivers : No steroid medications
Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire, use of antipsychotic medications, and suicidal ideations
Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, dementia, use of antipsychotic medications, suicidal ideations)
Prior use of brentuximab vedotin for GVHD is not allowed; prior use of brentuximab vedotin for the treatment of malignancy is allowed
PHASE II: If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study principal investigator (Pl)/co-PI or confirmed by reports in the medical record at MSKCC, by serf-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
Minocycline trial only: patients who are taking medication or have conditions that potentially preclude use of minocycline, as determined by the treating physician
Patients receiving maintenance therapy with myelosuppressive medications such as lenalidomide will be excluded
Megestrol use at the time of study enrollment
For patients taking medications known to have a significant interaction with lithium carbonate, these medications should be discontinued at least 1 week prior to and during lithium treatment
Patients must not have received topical analgesics (e.g., capsaicin preparations) or any other analgesics (e.g., opiates, tramadol, with the exception of nonsteroidal anti-inflammatory drugs [NSAIDs], combination NSAIDs, and acetaminophen) within 14 days prior to registration
Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)
Patients must not be planning to receive any of the following concomitant medications that can cause skin rash or other dermatologic reactions that could interfere with the EGFRI-induced skin toxicity assessments, for the duration of the study: allopurinol, systemic corticosteroids, topical retinoids (Retin-A, Tretinoin), oral retinoids (Amnesteem, Claravis, Sotret)
Current acknowledged use of amifostine trihydrate, cholinergic agonist medications (pilocarpine hydrochloride, cevimeline hydrochloride), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function
Able to walk 15 minutes at a time (use of a cane is acceptable)
Current use or use within past two weeks of an monoamine oxidase inhibitor (MAOI)
Concomitant use of medications known to induce a disulfiram-like reaction to alcohol
Initiation of sleep aids, including over-the-counter or prescription medications taken for insomnia (melatonin, benzodiazepines, antihistamines, etc.) for < 4 weeks prior to enrollment in the study
Use of medication for treatment of another sleep disorder, such as restless leg syndrome or narcolepsy
Patients with any condition that precludes use of the study medication as determined by the treating physician
Willing and able to use a computer to complete study questionnaires
Current use of anti-cancer cytotoxic chemotherapeutic agents
No blood?thinning medications, including anti?inflammatory medications, herbs and supplements for at least 1 week prior to surgery
Patients must have neuropathy greater or equal to 2 according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale, clinically evaluated within 30 days of consent, despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica for at least 30 days; patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed; patients are allowed to stop medications but not replace them with other medications
Concurrent use of other alternative medicines such as herbal agents and high dose vitamins
Planned or actual changes in type of medications that could affect symptoms related to CIPN; new medications for the treatment of CIPN are not allowed during the study; Note: subjects need to be on stable doses for 4 weeks
No aspirin (ASA) or non-steroidal anti-inflammatory drugs (non-steroidal anti-inflammatory drugs [NSAIDS]) administration
All patients who currently use a urinary drainage bag for a period of at least 7 days prior to signing consent for the study and who are expected to use the urinary drainage bag for an additional period of 4 weeks or more based on the diagnosis
No exclusion is necessary based on the use of other concomitant medications; specifically there is no prohibition of concomitant antibiotic, antiviral or antifungal therapy; subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
Current oral steroid use or receiving daily therapeutic anticoagulation (e.g. Coumadin, Lovenox)
Baseline gabapentin use
Use of psychotropic medications within the past month or current use of medications that would interfere with autonomic nervous system measures
Patients take prescribed sedative hypnotics or sleep medications
Unwilling to use personal phone/tablet to test intervention
Subjects must agree to not use any other topical agents on skin in the radiation treatment area during the course of this trial; subjects should only use topical agents for the study (i.e., topical intervention or standard care agents) supplied by the study personnel and/or treating physician
Currently taking anti-hypertensive medications
Be taking anticoagulant medication (does not include aspirin)
Patients unable to tolerate discontinued use of anti-coagulants prior to and during the ablation procedure.
Sexually active males who are unwilling to use a condom during intercourse while taking the study drug and for 6 months after stopping investigational medications and agree not to father a child in this period
Rescue pain medications are allowed this may include the use of nonsteroidal anti-inflammatory drugs (NSAIDS) or Tylenol as well as morphine immediate release (IR)
Concurrent use of adjuvant medication such as but not limited to: gabapentin, pregabalin or duloxetine etc.; NOTE: patients on gabapentin or pregabalin can be considered if they can be tapered off before enrolling on the study
Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 +/- 2 days through day 28 +/- 2 days)
Use of non-steroidal anti-inflammatory drugs and aspirin is allowed but must be tracked
Other exclusion criteria include: illicit drug use, shift work, current dieting, excessive regular use of alcohol (more than two 5 ounce glasses of wine or equivalents/day) or a history of binge drinking (more than 7 drinks/24 hour period) within the last 6 months
Use of thyroid medication at the time of screening
Use of Coumadin or acenocoumarol at time of screening
Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
History of chronic pain, long-term narcotic use or being considered for chronic pain consultation postoperatively
Ongoing use or planned peri-operative use of anticoagulants (not including deep vein thrombosis [DVT] prophylaxis)
Patients who cannot be effectively reconstructed without the use of bioprosthetic mesh
Use of allopurinol within 72 hours of the study entry
Able to list all current medications and medical conditions
Participants taking illegal drugs
Chronic steroid use
Subject meets the following medication restriction requirements and agrees to follow medication restrictions during the study; the following concomitant medications are not allowed: cyclophosphamide, abatacept, etanercept, adalimumab infliximab, golimumab, tofacitinib, and alemtuzumab; these medications also cannot have been used for 5 half-lives prior to enrollment
Patients must have neuropathy greater or equal to 2 according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 scale despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica; patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed; patients will be removed from the study if a change in type of medication is necessary; patients are allowed to stop medications but not replace them with other medications
Concurrent use of other alternative medicines such as herbal agents and high dose vitamins and minerals
Planned or actual changes in type of medications that could affect symptoms related to peripheral neuropathy (PN); new medications for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) are not allowed during the study; Note: subjects need to be on stable doses of CIPN medications for 4 weeks
Planned use of leucovorin (because of the risk of secretory diarrhea)
Current or planned use of other agents for treating hot flashes
Current or planned use of any type of antidepressants
Pregnant women are not eligible as the self-collection device is not recommended for use in this group
Written authorization for use and release of health and research study information has been obtained
Current use of (1) medications/supplements to control blood pressure (e.g. beta-blockers, nitrates, calcium channel blockers, phosphodiesterase-5 [PGE5] inhibitors) or (2) the use of statins for cholesterol;
Currently prescribed anti-coagulation medications (ReoPro [abciximab], Aggrenox [aspirin plus dipryridamole], Persantine [dipyridamole], Integrillin [eptifibatide], Ticlid [ticlopidine], Aggrastat [terofiban], Heparin, Coumadin [warfarin], Pradaxa [dabigatran], Xarelto [rivaroxaban])
Patients must not be receiving or plan to receive concomitant oral or intravenous corticosteroids on a regular basis, nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular or predictable intermittent basis; (NSAID use may not exceed 10 days per month); patients may receive daily aspirin for cardiovascular prophylaxis as long as acetylsalicylic acid (ASA) is =< 100 mg per day or =< two 325 mg tablets per week; inhaled steroids (i.e. for asthma or related conditions) are allowed
Use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of enrollment
Use of any other blood pressure lowering medication for treatment of hypertension within 30 days of enrollment except calcium channel blockers and diuretics
For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and
Current use of thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) that will be continued on study
Current daily use of aspirin (> 81 mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g. ibuprofen > 800 mg daily or equivalent)
Willing to discontinue taking nonsteroidal anti-inflammatory drugs (NSAIDS) for 30 days prior to initiation of and during intervention; exception: use of =< 81 mg daily or =< 650 mg weekly aspirin is allowed
Regular (>= 2 times per week) use of drugs that alter the pH of the gastrointestinal tract (GI) tract, such as proton pump inhibitors (PPI) and antacids; exceptions: individuals who use prescription PPIs and have approval from their primary health care provider to replace the PPI with an H2 receptor agonist, i.e. ranitidine, for the duration of the trial will be eligible
Statin use or statin use is indicated based on guidelines
Use of systemic hormone replacement therapy (HRT) in the last 30 days prior to the randomization; the use of non-systemic estrogen (such as vaginal estrogen use) is allowed
Willingness to discontinue smoking during the study two weeks prior to beginning the study and willingness to not smoke while taking study medication
Participants who regularly (>= 2 times per week) use drugs that alter the pH of the gastrointestinal (GI) tract, such as proton pump inhibitors (PPI) and antacids; exceptions: individuals who use prescription PPIs and have approval from their primary health care provider to discontinue for the duration of clinical trial participation may be enrolled; an alternate drug to control gastroesophageal reflux disease (GERD)/peptic ulcer disease (PUD) symptoms will be suggested
Willingness to avoid excessive use of alcohol during the study; note: excessive use is defined as drinking >= 8 alcoholic drinks per week on average
Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism
Current tobacco smokers with >= 20 pack years of self-reported smoking exposure and an average use of >= 10 cigarettes/day
Not willing or are unable to refrain from use of any non-study ASA, NSAIDs and leukotriene antagonists during the study period
Chronic, current or recent (within the past three months) use of glucocorticoids (systemic, topical and/or nasal sprays or steroid topical creams to large body surface area); use of steroid topical creams for small body areas (=< 10% body surface) during study intervention is allowed
Prior or current use of statin medication
RECIPIENT: Planned medications from the time of HCT to day 70 post?HCT
RECIPIENT: Other medications that might interfere with the evaluation of the investigational product
Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.
SOCIAL MEDIA STUDY: Use of IT at least 10 times in the past year to be consistent with the proposed intervention criteria
SOCIAL MEDIA STUDY: Daily use of Facebook
Current use of tobacco cessation medications.
Current tobacco smokers with >= 20 pack years of self-reported smoking exposure and a current average use of >= 10 cigarettes/day
Current use of a retinol containing agent or any retinoid analogue drug within the last 30 days
Current or planned use of anticoagulants other than aspirin or non-steroidal anti-inflammatory agents
Use of any drugs or substances known to be CYP3A4 substrates with narrow therapeutic range within 1 week prior to Day 1, or planned to be used during the overall study period.
Psychosocial issues: no appropriate caregivers identified, or non-compliant to medications
Currently taking psychotropic or cardiovascular medication
Taking any smoking cessation medications (e.g. varenicline, bupropion, nicotine replacement therapies) at the start of the study
Currently taking psychotropic or cardiovascular medication
Current smoker (defined as any smoking in the past 30 days – this is the criteria our lung cancer screening programs will use to trigger tobacco treatment interventions)
Current use of certain medications: (1) Smoking cessation medications (meds) (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix.
Patient has taken the following agents within the last 48 hours prior to the start of treatment with study drug:\r\n* 5-hydroxytryptamine (HT3) antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.); palonosetron is not permitted within 7 days prior to administration of investigational product\r\n* Benzamides (metoclopramide, alizapride, etc.)\r\n* Domperidone\r\n* Cannabinoids\r\n* Neurokinin-1 (NK1) antagonist (aprepitant)\r\n* Benzodiazepines (lorazepam, alprazolam, etc.)\r\n* Herbal medications or preparations in doses designed to ameliorate nausea or emesis
Current (within three weeks of randomization) or planned use during the study intervention of the following:\r\n* Aspirin, other nonsteroidal antiinflammatory drugs (NSAIDs), or COX-2 inhibitors\r\n* Anticoagulants, antiplatelet agents, or corticosteroids\r\n* Gingko\r\n* Ethanol consumption > 1 standard drinks/day for women, or > 2 standard drinks/day for men\r\n* Methotrexate (MTX)\r\n* Study participants will be instructed to use Tylenol or some other non-excluded agent to treat common ailments (i.e. headache/minor aches and pains)
Use of investigational drugs within 3 weeks of signing consent or foreseen use during the study
Use of laxatives within the past 7 days
Use of chronic laxatives (>= 30 consecutive days)
Use of anti-diarrheal agents (including but not limited to loperamide, octreotide, bismuth, tincture of opium, atropine, probiotics in any form other than food) within the past 7 days
Willingness to avoid the use of curcumin or any over-the-counter or prescription medications containing curcumin or curcuminoids
Patients who have taken non-steroidal anti-inflammatory drugs (NSAIDs) in the past two weeks
Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic glucocorticoids within 28 days of the first planned dose of PROSTVAC-V/F; use of inhaled steroids, nasal sprays, and all topical preparations (creams, solutions, gels, ointments, etc.) for up to 5% of the body surface area is allowed
Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than tobacco use disorder) in the past month that may interfere with study performance based on principal investigator (PI) judgment
Current use of medications with smoking cessation efficacy
Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
Plan to use other nicotine substitutes (i.e., over-the-counter [OTC] or prescription medication for smoking cessation) or smoking cessation treatments in the next 6 months
Current use of certain medications: \r\n* Smoking cessation meds (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix\r\n* Certain medications to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), or \r\n* Other medications listed on the exclusionary medications list
Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., pipe, cigar) and unwilling to stop use for the study period
Patients currently using a smoking cessation medication – any medications prescribed to help with smoking cessation except short acting nicotine replacement therapy (NRT): gum, lozenges, spray, inhalers
Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition, dietary or alternative medications/supplements for the duration of the study
Are taking immunosuppressant medications, bisphosphonates or steroid medications
Are taking any medications that have known impact on immune responses (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] for chronic pain) or are actively being investigated for the prevention of tobacco related cancers will not be acceptable; a single 81 mg aspirin per day will be acceptable
Use of any non-aspirin non-steroidal anti-inflammatory drug (NSAID) at any dose at least three times a week during the two months prior to randomization
Inability or unwillingness to abstain from non-protocol use of aspirin or NSAIDs or to provide blood, urine, or stool samples or colon biopsies during the study
Concomitant non-steroidal anti-inflammatory drug (NSAIDS) or other anticoagulant/antiplatelet therapy, including acetylsalicylic acid (Aspirin) (ASA) > 81mg/day
Chronic use of omega-3 fatty acid concentrates or capsules within the 3 months prior to entry on the study or any other supplements that might interact with omega-3 fatty acid supplements
As iloprost inhibits platelet function, patients must not be taking anticoagulants, with the exception of aspirin or other non-steroidal anti-inflammatory medications
Regular use of any form of tobacco other than cigarettes;
Plan to use other nicotine substitutes (i.e., over-the-counter [OTC] or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months
Current use of certain medications: (1) smoking cessation medications (meds) (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT, Chantix, (2) certain medications used to treat depression (last 14 days), i.e. monoamine oxidase inhibitors (MAOIs) and Elavil (amitriptyline), (3) a case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however as needed (PRN) use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month’s duration)
Use anti-diabetic medication (including insulin)
Prior tamoxifen or raloxifene use in the past 1 year.
For Zyban:\r\n* Pregnant or breast feeding or planning to become pregnant in the next 6 months\r\n* History of seizure disorder or head trauma\r\n* History of severe allergic reaction to Zyban (also known as Wellbutrin, Bupropion)\r\n* History of eating disorder, such as anorexia or bulimia, which is overeating and throwing up\r\n* Currently taking Wellbutrin, Zyban or any other medications that contain bupropion\r\n* History of alcohol or substance abuse in the past year\r\n* Current excessive alcohol consumption defined as 14 or more alcoholic drinks per week and/or binge drinking (5 or more drinks on one occasion) 2 or more times in the past month\r\n* Use of monoamine oxidase (MAO) inhibitors, such as Nardil, tranylcypromine, phenelzine, or Parnate\r\n* Reported use of illegal drugs (opiates, cocaine, narcotics, or other stimulants such as diet pills)\r\n* Use of psychoactive medications, such as fluoxetine, doxepin, clonidine, or buspirone\r\n* Use of benzodiazepines, such as Xanax, Valium, Ativan, Klonopin in the past 2 weeks
Current use of statin medication or statin use within 12 months of screen 1 visit
Current systemic use of medications known to interact with statins and potentially increase toxicity, including (e.g., gemfibrozil, cyclosporine, clarithromycin, colchicine, niacin and fibrates)
A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted)
Current or anticipated need for daily aspirin or NSAID use including aspirin for cardiovascular protection
use of hair dyes
Daily use of Facebook
Use of digoxin and licorice
Current use of blood anticoagulant drugs such as dicumarol (Warfarin), clopidogrel (Plavix), prasugrel hydrochloride (HCl) (Effient), ticlopidine (Ticlid), Lovenox (Enoxaparin), Fragmin (Dalteparin), Innohep (Tinzaparin), eptifibatide (Integrilin), tirofiban (Aggrastat), and abciximab (ReoPro)
Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders) or substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview [MINI])\r\n* Alcohol use disorder: current mild disorder is eligible; moderate disorder is eligible if in early remission (3-12 months); severe disorder, current or early remission, is not eligible\r\n* Substance use disorder is as follows: current disorder is not eligible; mild or moderate in early remission is eligible; severe disorder in early remission is not eligible
Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 7 days prior to starting naproxen or placebo on this study; consultation with the participant’s primary care provider may be obtained but is not required; the use of the following drugs or drug classes is prohibited during naproxen/placebo treatment:\r\n* Investigational agents\r\n* NSAIDs: such as aspirin, ketorolac and others NSAIDs\r\n* COX-2 inhibitors: such as celecoxib, rofecoxib and other COX-2\r\n* Antiplatelet agents: such as aspirin, clopidogrel, ticlopidine, dipyridamole, abciximab, tirofiban, eptifibatide and prasugrel\r\n* Anticoagulants:\r\n** Heparin\r\n** Heparinoids: such as fondaparinux, danaparoid and other heparinoids\r\n** Low-molecular weight heparins: such as enoxaparin, dalteparin, parnaparin, reviparin, tinzaparin, ardeparin, certoparin, lepirudin, bivalirudin\r\n** Other anticoagulants: argatroban, apixaban, dabigatran, rivaroxaban, warfarin, acenocoumarol, dicumarol, phenindione and other anticoagulants\r\n* Lithium\r\n* Selective serotonin and norepinephrine reuptake inhibitors: milnacipran, fluoxetine, paroxetine, nefazodone, citalopram, clovoxamine, escitalopram, flesinoxan, femoxetine, duloxetine, venlafaxine, vilazodone, sibutramine, desvenlafaxine\r\n* Anticonvulsants: phenytoin, paraldehyde, valproic acid, carbamazepine, trimethadione, phenobarbital, diazepam, chlormethiazole, mephenytoin, ethotoin, paramethadione, phenacemide, mephobarbital, oxcarbazepine, zonisamide, piracetam, vigabatrin, felbamate, gabapentin, beclamide, fosphenytoin, stiripentol, tiagabine, topiramate, pregabalin, lacosamide, rufinamide, caramiphen\r\n* Antibiotics and antifungals:\r\n** Fluoroquinolones : such as ofloxacin, norfloxacin, levofloxacin\r\n* Other agents: teriflunomide, cyclosporine, tacrolimus, ginkgo, gossypol, meadowsweet, feverfew, beta glucan, pentosan, pentoxifylline, cilostazol, erlotinib, pemetrexed, methotrexate, pralatrexate
Chronic proton pump inhibitor (PPI) use or histamine (H2) blocker use that cannot be temporarily discontinued (at least 48 hours)
Any acetaminophen, aspirin, non-steroidal anti-inflammatory drugs (NSAID), or statin use within 2 days of testing (known to affect mitochondrial function)
Chronic use of systemic antibiotics; topical lotions which include antibiotics are permitted; occasional use of antibiotics is allowed, but must be stopped for 3 weeks prior to RPFNA and for 3 weeks prior to collecting blood or urine specimens for the pre-study (i.e., prior to dispensing/starting study agent) assessment of lignan levels
Regular consumption of non-prescription anticoagulants, such as aspirin, NSAIDS or fish oil during the 3 weeks prior to baseline RPFNA is strongly discouraged, but occasional use will not exclude subject from participation
Current use of statin therapy
Current use of rifampin and digoxin
Excessive use of acetaminophen or other potentially hepatotoxic drugs
Is receiving any prohibited drugs
Concurrent use of antacids, hydrogen (H2) antagonists, proton-pump inhibitors, or medications known to inhibit or induce hepatic enzyme cytochrome P450 (CYP) 3A4
Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the 3 months prior to entry on the study or any other supplements that might interact with NEC
No use of antibiotics in the previous 3 months; or current regular use of antibiotics
Not currently using immunosuppressant medications
Cleared to participate in moderate intensity exercise by:\r\n* Answering “no” to all questions of the physical activity readiness questionnaire (PAR-Q), with the exception of current use of prescription medications, which is permitted\r\n* Written clearance from primary care practitioner
Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab (bisphosphonate use for prevention of skeletal events allowed)
Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 1 month prior to starting aspirin or placebo on this study; consultation with the participant’s primary care provider will be obtained prior to stopping any agent; the use of the following drugs or drug classes is prohibited during aspirin/placebo treatment:\r\n* NSAIDs: such as aspirin, Naprosyn, ketorolac and others NSAIDs\r\n* COX-2 inhibitors: such as celecoxib, rofecoxib\r\n* Valproic acid\r\n* Sulfinpyrazone\r\n* Probenecid\r\n* Corticosteroids (other than short-term use defined as less than 2 weeks or pro re nata [prn (when necessary)] use of an inhaler less than twice per month)\r\n* Platelet aggregation inhibitors, except in a monitored antithrombotic regimen\r\n* Methotrexate (MTX)\r\n* Vaccines containing live viruses\r\n* Gingko
Subjects with pre-operative urinary incontinence defined as use of pads or adult diapers;
May use adjuvant endocrine therapy if use will be continued for duration of study period
Regular, necessary use of nonsteroidal anti-inflammatory drugs (NSAIDs) (will be asked to stop use during study period)
Subjects with chronic treatment (at least twice/week for more than 3 months) with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
Current or planned use of immunomodulators including: infliximab, 6?MP (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs
Treatment with medications that are known to carry a risk of Torsades de Pointes
Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is permitted perioperatively.
Use of medications that induce, inhibit or are substrates of CYP450 3A4 within 7 days prior to the first veledimex dosing
Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:\r\n* Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if used as an appetite stimulant is allowed)\r\n* Concurrent treatment with bisphosphonates is permitted; however, treatment must be initiated prior to the first dose of study therapy; prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis\r\n* Concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John’s wort, kava, ephedra [ma huang], gingko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Patients who need to continue treatment with any prohibited medications
Patients who have not completed the appropriate washout period for the prohibited medications
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of romidepsin will be determined following review of their case by the site principal investigator\r\n* Patients treated with any of the medications prohibited must discontinue their use at least 7 days prior to the first dose of romidepsin; certain other agents that interact with the CYP3A4 system may be used with caution
Use of systemic antibacterial, antifungal, or antiviral medications for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is allowed perioperatively
Use of medications that induce, inhibit, or are substrates of cytochrome p450 (CYP450) 3A4 within 7 days prior to veledimex
Use of heparin or acetylsalicylic acid (ASA)
Prior use of CC-122 (Arm B)
History of daily use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) in the week preceding study entry
Current use of anti-coagulants
Any concurrent medication with a known risk of inducing Torsades de Pointes, that in the investigator’s opinion cannot be discontinued
Current narcotic use
A current or ex-smoker with a >= 10 pack-year history of smoking; (an ex-smoker is defined as no tobacco use in the prior 6 months)
Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism
Willing to use double-barrier protection if sexually active
Psychotropic medications
Other types of tobacco, NRT, smoking cessation medications
Use of any other influenza vaccine for the 2015 to 2016 flu season
Current use of nicotine replacement therapy (NRT)
Current use of other smoking cessation medications (e.g., Chantix or Zyban)
Regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (i.e. regular use of non-steroidal anti-inflammatory medication, insulin therapy, steroid therapy, or antibiotics)
Planned use of anti-thymocyte globulin (ATG) or alemtuzumab in conditioning regimen.
Inability to withhold agents that may interact with hepatic cytochrome P450 enzymes (CYP3A4), or glutathione S-transferases involved in bortezomib and/or busulfan metabolism during day -5 through day +7. It is acceptable to use alternative non-interacting medications during this period, and then resume prior medications.
Male or female current tobacco smokers with >= 20 pack years of self-reported smoking exposure and an average use of >= 10 cigarettes/day
Not willing or are unable to refrain from use of any non-study ASA or NSAIDs during the study period
Willingness to abstain from grapefruit juice, alcohol, and concomitant medications during study
Use of laxatives more than 3 times per week
Current use of >= 5 cigarettes/day
Current use of >= 3 alcoholic drinks/day
Use anti?platelet agents within two weeks of anticipated sigmoidoscopy
Use of anti?coagulants within two weeks of anticipated sigmoidoscopy
Use of any illicit or illegal substances detected by urinary drug screen
Participants must agree to discontinue all vitamin supplements while taking study medication and for thirty days past the last dose of study medication
Participants may not be taking medications that might interact with 9cUAB30
Taking prescribed medication to control their lipids
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed.
Patients taking Vitamin D supplements during the study, unless they have been taking Vitamin D supplements for 30 days or more prior to the start of the study and that the dose of the Vitamin D supplement remain the same throughout the study.
Patients treated with medications that are known to affect calcium levels within 4 weeks of initiation of topical therapy (>500 IU vitamin A, calcium supplements, fluoride, antiepileptics).with the exception of subjects on stable therapy for more than six months
Current or prior use of bone active medication (bisphosphonates, teriparatide, selective estrogen receptor modulators, or denosumab)
There will be no restrictions regarding use of other investigational agents
There will be no restrictions regarding use of other investigational agents
Use of medications known to interfere with 123I-mIBG uptake (principal considerations are phenylephrine and pseudoephedrine containing compounds which need to be discontinued for 48 hours, and labetalol which needs to be discontinued for 6 weeks)
Have CT scans within 30 days suitable for use with the virtual bronchoscopic system
For non-smokers, no significant lifetime exposure to any nicotine-containing product, where significant exposure is defined as daily use of any nicotine-containing product for more than one week or once monthly use for more than 6 months
Patients taking retinoid medications by mouth (such as acitretin, isotretinoin), strontium ranelate may not take demeclocycline because of toxic interactions
HEALTHY VOLUNTEER: Evidence of current ongoing illicit drug use or average alcohol use of greater than 2 drinks a day
HEALTHY VOLUNTEER: Use of more than 5 cigarettes/day
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto) cannot be taken while patients are receiving enzalutamide
Current use of cholinesterase inhibitors, other cognitive enhancers, antipsychotics, antidepressants, or anticonvulsant medications
Current use of gabapentin or venlafaxine for hot flashes
Requirement for medications, which interfere with platelet function, such as aspirin, which cannot be stopped within 1 week prior to the biopsy (applicable only to patients undergoing biopsy)
Urinary incontinence requiring condom catheter use or >= 1 pad/day
Use of neoadjuvant hormonal manipulation
Concomitant medications for treatment of the target lesion
Patient must not be taking non-steroidal anti-inflammatory drugs (NSAIDS), clopidogrel, dipyridamole, or aspirin therapy > 81 mg/day
Prior use of radiosensitizers, Gliadel wafers, or other interstitial intracranial treatments
Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > upper limit of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy; patients who are receiving denosumab must discontinue denosumab use and replace it with a bisphosphonate instead while on study; patients receiving a bisphosphonate for skeletal metastases are not excluded and can continue treatment
the use of a male condom during each act of sexual intercourse.
Patients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not a prohibited medication
Is able to take medications orally (e.g., no feeding tube).
Is a regular user (including recreational use) of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse
Prior use of lorlatinib (PF-06463922)
Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices such as astemizole, terfenadine, cisapride, pimozide, quinidine, tacrolimus, cyclosporine, sirolimus, (alfentanil and fentanyl, including transdermal patch) or ergot alkaloids (ergotamine, dihydroergotamine) should be used with caution
Concurrent use of drugs that are CYP2C9 substrates with narrow therapeutic indices, such as warfarin, phenytoin or a sensitive substrate such as celecoxib should be used with caution
Concurrent use of drugs that are sensitive CYP2B6 substrates, such as bupropion, efavirenz should be used with caution
Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
Use of anticoagulants that cannot be discontinued in order to guarantee an INR below 1.5
Concomitant medications for treatment of the target lesion
Be taking metformin, aminoglycosides, other nephrotoxic medications, or daily use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Prior diagnosis of asthma, OR use of an inhaler in past three years to treat or prevent bronchospasm
Current use of medications to control blood pressure or improve cardiac output
Routine daily use of duloxetine and/or milnacipran
Patient is taking any photosensitizing drugs
Use of concomitant medications with evidence for an association with drug-induced mitochondrial optic neuropathy including systemic administration of ethambutol, chloramphenicol, linezolid, erythromycin, streptomycin, and zidovudine.
Women must not breast-feed while taking the study medications
Herbal preparations are not allowed throughout the study; these herbal medications include, but are not limited to: St. John’s wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, Seville oranges, pummelos, and exotic citrus fruits from 14 days prior to the dose of study medication and during the entire study due to potential CYP3A4 interaction with the study medication; orange juice is allowed
The use of statins including atorvastatin are prohibited and patients should be moved on to non-breast cancer resistance protein (BCRP) alternatives
Regular use of supplemental vitamin D totaling >= 2,000 IU/day in the past year\r\n* Use of supplemental vitamin D or supplements containing vitamin D beyond the protocol-prescribed study treatment is not allowed during the treatment period of this clinical trial\r\n* In order to maintain blinding, vitamin D levels should not be routinely checked at screening or during the study by the treating investigator; vitamin D levels will be assayed only as part of the research blood samples collected during the study; if there are concerns related to a participant’s vitamin D status, the lead principal investigator should be contacted for further discussion
Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted
Regular use of thiazide diuretics (i.e., hydrochlorothiazide), which can lead to hypercalcemia, and unwillingness or inability to discontinue or switch to an alternative anti-hypertensive agent
Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional ULN, corrected for albumin level if albumin is not within institutional limits of normal)\r\n* The use of supplemental calcium or supplements containing calcium is prohibited during the treatment period of this clinical trial
Patients currently taking other sedative hypnotic medications
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed
Willing to use electronic (e)-cigarettes
No contraindications for e-cigarette use
Chronic proton pump inhibitor, H2-blocker (i.e., ranitidine, famotidine), and/or calcium carbonate use
Use of metronidazole or antabuse during the study
Taking ibuprofen, naproxen, other non-steroid anti-inflammatory drugs (NSAIDs), steroids (except inhaled steroids) within 14 days of study registration
Concomitant cyclosporine, gemfibrozil, telaprevir, or tipranavir/ritonavir use
Regular use of laxatives (e.g. Ex-lax, Dulcolax, Miralax) that may affect the microbiome >= 2 days a week
Aim 2 only: Smokeless tobacco users who use ST daily (>= 6 dips or pouches/day) for at least 6 months and no other tobacco use or e-cig use for at least 1 year (ST use will be confirmed by salivary cotinine), and in good physical and mental health; no serious quit attempts in the last three months particularly for those randomized to the control condition
Use of inhalant medications
Allergies to study medications, such as, lidocaine, Versed, or Cetacaine
Other tobacco use within the past year for 7 consecutive days or 14 times
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
Participants must be willing to discontinue any use of nonsteroidal antiinflammatory drugs (NSAIDs) like aspirin or ibuprofen until the tumor is removed
Use within the last month of nicotine replacement or other tobacco cessation products for purpose of quitting; situational use of nicotine replacement is not a reason for exclusion (to prevent undermining of cessation efforts)
Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements
Use of thyroid replacement medication (Synthroid or similar) for < 1 year
Willing to abstain from procreative sex or partake in appropriate form of contraception; for the purpose of this study, condom use or abstinence will be required
Prior use of degarelix, enzalutamide, trametinib, or dasatinib in any context
Use of any medications known to affect the serum androgen levels or the PSA
Current usage of VPA or Dex, if patient has been on these medications in the past but is not currently taking them she is still a candidate for the study; prior use must be greater than one month for VPA; there is no “wash out” period required for DEX
Women must not breast-feed while taking the study medications
Subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study. Inhaled steroids and intra-articular steroid injections are permitted in this study.
Has history or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
Ability and willingness to abstain from all medications and dietary supplements for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration; topical medications and inhaled medications that do not contain steroids are permitted
Chronic medication use that cannot be safely stopped
Patients who will require anticoagulant medications other than routine deep vein thrombosis (DVT) prophylaxis within 8 days postoperatively
Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited to dihydroergotamine, ergotamine, and pimozide.
Current use of a prohibited medication or requires any of these medications during treatment with GSK1120212
Any major radiotherapy, or immunotherapy within the last four weeks; use of erythropoietin replacement or bisphosphonates is considered supportive care and their use is permitted
Concurrent administration of warfarin, full dose aspirin, clopidogrel, apixaban or other medications known to increase the risk of bleeding or with antiplatelet activities
Report tobacco use within the past 7 days
Patients must be willing to meet four times in person or on the phone to discuss tobacco use
Use internet on average at-least once a week (RCT)
Ability to understand and the willingness to use the PMSA on the patient’s personal smartphone
Patients who do not own smartphones or who do not use them for more than email, texting and calling
Current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report (e-cigarette users will be excluded if their average monthly use exceeds half of their average monthly use of conventional tobacco cigarettes)
Current use of medications such as chantix (varenicline), zyban, wellbutrin, or bupropion for any purpose, including stopping smoking
Use of any other medication that could impact dietary intake, such as prednisone
Participants requires the use of warfarin (use in prophylactic doses [example, deep vein thrombosis prophylaxis]) is allowed.
Use or consumption of:
Concomitant medications:
Anti-platelet agents: if currently receiving aspirin, ibuprofen or other non-steroidal anti-inflammatory or anti-platelet agents, not eligible
Requires intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
current use of any smoking cessation medications
Use of any ongoing medications which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin®, and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix.
no FDA contraindications for use of NRT:
Willingness and ability to use the telemonitoring device
Currently taking anticoagulant medications or clopidogrel
Is receiving any medication prohibited in combination with study chemotherapies as described in the respective product labels, unless medication was stopped within 7 days prior to randomization.
Concomitant systemic use of anticancer herbal medications. These should be stopped prior to study entry.
Requires intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
Currently taking a concomitant medication
Require therapeutic use of anticoagulation medications
Patients required to be on any of the concomitant medications are excluded
For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs