Participants must discontinue use of the following agents within 7 days prior to therapy\r\n* Strong CYP3A4 inhibitors that treat HIV\r\n* Other strong CYP3A inhibitors\r\n* Moderate CYP3A4 inhibitors should be used with caution but are not excluded; if 2 moderate CYP3A4 inhibitors are used concurrently, one must be discontinued at least 7 days (1 week) prior to the initiation of chemotherapy\r\n* P-glycoprotein inhibitors\r\n* If patients are taking any of these excluded medications, they must be discontinued at least 7 days (1 week) prior to the initiation of chemotherapy\r\nAll concomitant medications must be reviewed by the study chair or co-chair prior to enrollment by email; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of
Patients must not be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipravavir/RIT, or voriconazole); strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); potent inhibitors of CYP1A2 (e.g. ciprofloxacin); and/or drugs known to be CYP3A4 substrates with a narrow therapeutic range (e.g., diergotamine, ergotamine) within 14 days prior to randomization; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution
Concomitant medications\r\n* Chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors is not allowed; patients must discontinue the drug at least 14 days prior to study registration\r\n* Chronic concomitant treatment with CYP1A2 substrate is not allowed; patients must discontinue the drug at least 14 days prior to study registration
Treatment with clinically significant metabolic CYP3A inducers within 14 days before the first dose of study drug; clinically significant CYP3A inducers are not permitted during the study
Current use or anticipated need for food or medications that are known strong CYP3A4 inhibitors/inducers, including their administration within 7-days prior to the first gedatolisib (PF-05212384) or palbociclib dose and during study treatment
Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19.
Strong CYP3A4 and CYP2C8 inhibitors or inducers or CYP3A4 substrate drugs with a narrow therapeutic range taken within 14 days or 5 drug half-lives before start of study drug.
Currently receiving medications known to be inhibitors of CYP3A4/5. Subjects currently receiving medications of known inducers of CYP3A4/5 or substrates of CYP2C8/9 and CYP1A2 may be excluded.
Inclusion Criteria for all Modules:\n\n          1. Metastatic MIBC\n\n          2. 2nd/3rd line\n\n          3. Failed adjuvant/neo-adjuvant chemotherapy <1 yr\n\n          4. 1 lesion ?10 mm at baseline in the longest diameter suitable for accurate repeated\n             measurement\n\n          5. WHO perf. status 0-1\n\n        For Module A:\n\n          1. M/F ?25\n\n          2. Confirmation of FGFR3 mutation or FGFR fusion\n\n        For Module B:\n\n          1. Hgb ?10 g/dL\n\n          2. Deleterious mutation, deletion or truncation in any HRR genes\n\n        For Module C:\n\n        1. Tumour harbours a deletion or inactivating mutation of the CDKN2A or RB1 genes and/or\n        amplification of CCNE1, MYC, MYCL or MYCN genes\n\n        For Module E:\n\n        1. Contraception must be sustained throughout treatment with vistusertib and 16 wks after\n        last dose\n\n        For Module F:\n\n          1. Adequate organ and marrow function, defined as Leukocytes ?3.0x10(exp9)/L; ANC\n             ?1.5x10(exp9)/L; platelets ?100x10(exp9)/L\n\n          2. Contraceptive measures must be sustained throughout treatment with AZD9150 and for 180\n             days after the last dose.\n\n        Exclusion Criteria for all Modules:\n\n          1. Immunotherapy, chemotherapy, anticancer agents, radiotherapy <4 wks, or radiotherapy\n             for palliation <2 wks, any study drugs <30 days.\n\n          2. Major surgery <4 wk\n\n          3. Unresolved toxicities from prior therapy\n\n          4. Concurrent chemotherapy, immunotherapy, biologic or hormonal therapy\n\n          5. Immunosuppressive drugs <28 days\n\n          6. Any of the following: Autoimmune disease ?2 yr; IBD; primary immunodeficiency; organ\n             transplant requiring immunosuppressives\n\n          7. Spinal cord compression or brain metastases, treated and stable & not requiring\n             steroids for at least 4 weeks\n\n          8. Severe or uncontrolled systemic disease\n\n          9. Any of the following: Mean QTc ?470 ms; abnormalities in resting ECG; factors that\n             increase the risk of QTc prolongation or arrhythmia; uncontrolled hyper/hypotension;\n             LVEF <55%; atrial fibrillation; NYHA Grade II-IV; severe valvular disease;\n             uncontrolled angina; stroke/TIA <6 months; acute coronary syndrome <6 months\n\n         10. Any of the following laboratory values: ANC <1.5x10(exp9)/L; Platelets\n             <100x10(exp9)/L; Hgb <9.0 g/dL; ALT >2.5xULN or >5xULN with liver mets; Total\n             bilirubin >1.5 times ULN or with Gilbert's disease ?2×ULN; Creatinine >1.5xULN\n             concurrent with creatinine clearance <50 mL/min; Corrected Ca >ULN, PO4 >ULN\n\n         11. Active infection including tuberculosis, hepatitis B (HBV), hepatitis C (HCV), or\n             human immunodeficiency virus. Patients with a past or resolved HBV infection are\n             eligible. Patients positive for HCV antibody are eligible only if polymerase chain\n             reaction is negative for HCV RNA.\n\n         12. Live attenuated vaccination <30 days\n\n        For Module A:\n\n          1. Prior exposure to: Nitrosourea or mitomycin C <6 weeks; any agent with FGFR inhibition\n             as its primary pharmacology; AZD4547; potent inhibitors/inducers of CYP3A4, inhibitors\n             of CYP2D6 or substrates of CYP3A4 <2 wks\n\n          2. Ophthalmological criteria: RPED; laser treatment or intraocular injection for macular\n             degeneration; age-related macular degeneration; retinal vein occlusion; retinal\n             degenerative disease; other clinically relevant chorioretinal defect\n\n          3. Refractory nausea/vomiting, chronic GI diseases, or previous bowel resection\n\n        For Module B:\n\n          1. Transfusion <120 days\n\n          2. Concurrent medications that are strong inhibitors of cytochrome P450 (CYP) 3A (CYP3A)\n             or strong inducers of CYP3A4.\n\n          3. Previous treatment with PARP inhibitor, including olaparib\n\n          4. Patients with history of MDS or AML\n\n        For Module C:\n\n          1. Prior exposure to any of the following: Nitrosourea or mitomycin C <6 wks; any agent\n             with Wee1 inhibition as its primary pharmacology; prior treatment with AZD1775\n\n          2. Any drugs or products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates\n             with narrow therapeutic index, or moderate to strong inhibitors/inducers of CYP3A4\n\n          3. Herbal preparations\n\n          4. Refractory nausea and vomiting or chronic GI diseases\n\n          5. Cardiac disease <6 months\n\n        For Module E:\n\n          1. Minor surgery <14 days of first dose\n\n          2. Exposure to specific substrates of OATP1B1, OATP1B3, MATE1 and MATE2K <5x half-life\n             before treatment. Exposure to strong/moderate inhibitors/inducers of CYP3A4/5, Pgp\n             (MDR1) and BRCP if taken within washout periods before the first dose\n\n          3. Haemopoietic growth factors (filgrastim, sargramostim, GM-CSF) <14 days prior to\n             treatment\n\n          4. Other mTOR inhibitors\n\n          5. Renal disease or renal tubular acidosis\n\n          6. Uncontrolled Type 1 or 2 diabetes\n\n        For Module F:\n\n        1. AST ? 2.5xULN or ?5xULN with liver mets
Co-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) or P-glycoprotein (PgP) is prohibited; co-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole) or PgP inhibitors may be used with caution and everolimus dosing must be discussed with principle investigator (PI) at the time of enrollment
The following medications are contraindicated or must be used with caution\r\n* Contraindicated:\r\n** Cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) strong and moderate inhibitors\r\n** CYP2C8 inducers\r\n** Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) strong and moderate inhibitors\r\n** CYP3A4 inducers\r\n** CYP3A4 sensitive substrates\r\n* Exclusions: the following supportive care medications will be allowed will be allowed as they are routinely administered with carboplatin and paclitaxel and have no potential interaction with talazoparib (BMN 673): dexamethasone, aprepitant, fosaprepitant, and ondansetron); oral pain medications such as hydrocodone, oxycodone taken on an as needed basis are also permitted\r\n* Transdermal products designed for systemic delivery must be assessed for interaction potential; topical products not designed to provide systemic delivery (including inhaled products, ophthalmologic products and transvaginal preparations) do not need to be considered\r\n* Other contraindicated medications (per above) are not allowed unless close monitoring with labs or drug levels or by symptoms with subsequent dose adjustments is feasible; patients taking these concurrent medications are ineligible unless they can discontinue or switched to alternative medications prior to initiation of the study drug (at least 5 half-lives)\r\n* Use with caution:\r\n** CYP2C8 sensitive substrates\r\n** CYP2C8 weak inhibitors\r\n** CYP3A4 non-sensitive substrates\r\n** CYP3A4 weak inhibitors\r\n* These agents may be permitted if discontinuation is not feasible and no acceptable alternatives are available as determined by the treating physician; however, caution should be used; consider monitoring with labs or drug levels or by symptoms and consider dose adjustments of the medication
Patients who are currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A4 including herbal medications; Note: if a medication is incorrectly documented as prohibited in this protocol, documentation from the site pharmacist to the contrary will be acceptable for the purposes of registration
Participant has received the following within 7 days prior to the first dose of study drug: corticosteroid therapy, CYP3A inhibitors, CYP3A inducers.
Subjects using agents known to inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 7 days prior to study start
Treatment with strong inhibitors and/or inducers of CYP3A4, CYP2C9, or CYP2C19 within 7 days preceding the first dose of the study drugs.
Patient receiving treatment with medications that either strong inducers or inhibitors of CYP2C8 or CYP3A4/5, or patients receiving medication that prohibits proton pump inhibitors and that cannot be discontinued at least 1 week prior to start of treatment and for the duration of the study.
Mifepristone can both inhibit CYP3A4 and induce CYP3A4; addition of mifepristone to a pre-existing drug regimen may cause a mild and temporary increase in plasma drug concentration of drugs with significant CYP3A4 metabolism; medications that are strong inducers of CYP3A4 such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's wort may decrease plasma mifepristone levels; strong CYP3A4 inhibitor medications are expected to cause the largest increases in plasma mifepristone concentrations\r\n* Mifepristone may increase the plasma drug concentration of concomitant medications with metabolism mediated by CYP2C9/CYP2C8; drugs with the largest increases will be those whose metabolism is largely or solely mediated by CYP2C9/2C8 and include: non-steroidal anti-inflammatory drugs (NSAIDs) and warfarin
Subject takes cytochrome P450, family 3, subfamily A (CYP3A) inhibitors within 3 days or inducers within 7 days prior to the study drug administration; any questions or clarifications of these determinations should be brought to the attention of the principal investigator (PI); the PI will make the final determination on when it is safe to initiate ABT-348 (ilorasertib) therapy under circumstances where the magnitude or relevance of possible CYP3A4 inhibitors/inducers is unclear in the protocol appendix
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
Cobimetinib is metabolized by the hepatic cytochrome P3A4 (CYP3A4) enzyme. Drugs CYP3A4/5 inhibitors and inducers should be avoided Atezolizumab-Specific Exclusion Criteria (Cohorts II and III Only)
Concomitant use of CYP3A4 inhibitors
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.
Other medications:\r\n* Patients receiving other anti-neoplastic agents are excluded\r\n* Patients on enzyme-inducing anticonvulsive agents are excluded\r\n* Patients requiring strong CYP3A4 or PGP inducers or inhibitors are excluded\r\n* Patients requiring anticoagulation or with uncontrolled bleeding are excluded\r\n* Patients on steroids for symptom management must be on a stable dose for 7 days prior to start of treatment
The following medications may significantly increase the level of pirfenidone and should not be taken concurrently including: fluvoxamine, ciprofloxacin > 500 mg twice daily, systemically administered aminolevulinic acid, vemurafenib and enoxacin, any other strong inhibitors of P450 isozymes CYP1A2, CYP2C9, 2C19, 2D6, and 2E1 should be avoided
Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib in patients with newly diagnosed only.
Mifepristone can both inhibit CYP3A4 and induce CYP3A4; addition of mifepristone to a pre-existing drug regimen may cause a mild and temporary increase in plasma drug concentration of drugs with significant CYP3A4 metabolism; medications that are strong inducers of CYP3A4 such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's wort may decrease plasma mifepristone levels; strong CYP3A4 inhibitor medications are expected to cause the largest increases in plasma mifepristone concentrations\r\n* Mifepristone may increase the plasma drug concentration of concomitant medications with metabolism mediated by CYP2C9/CYP2C8; drugs with the largest increases will be those whose metabolism is largely or solely mediated by CYP2C9/2C8 and include: non-steroidal anti-inflammatory drugs (NSAIDs) and warfarin
Cabozantinib is metabolized by CYP3A4; the metabolism and consequently overall pharmacokinetics of cabozantinib could be altered by inhibitors and/or inducers or other substrates of CYP3A4; it is recommended that chronic concomitant treatment with strong CYP3A4 inhibitors (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John’s wort) or inducers should be avoided; if patients are taking any strong CYP3A4 inhibitors, alternate medications with no or minimal CYP3A4 inhibitors should be sought prior to trial enrolment; while mild inhibitors/inducers of these cytochrome P450 isoenzymes are not specifically excluded, investigators should be aware that cabozantinib exposure may be altered by the concomitant administration of these drugs, and avoidance is also recommended
Concomitant use of CYP3A4 inhibitors
Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib.
Drugs that potently inhibit or induce CYP3A4 should be administered with caution
Concurrent use of CYP3A4 inhibiting or activating medications
Concomitant use of CYP3A4 inhibitors
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 strong inhibitor or inducers of hepatic microsomal isoenzymes CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4/5, UGT1A1, UGT1A3 and transporters BCRP and P-gp
Concomitant use of cytochrome P450 (CYP3A4) inhibitors or inducers is allowed but should be monitored closely for the use of strong inhibitors and/or inducers; patient is strongly advised to avoid grapefruit or grapefruit juice and herbal supplements with high risk of interaction with CYP3A4 or CYP2C8, such as St. John’s Wort while on study
Patient has had prescription or non-prescription drugs or other products (ie, grapefruit juice) known to be moderate to strong inhibitors or inducers of CYP3A4, which cannot be discontinued 14 days before day 1 of dosing and withheld throughout the study until 14 days after the last dose of AZD1775; co-administration of aprepitant and fosaprepitant during this study is prohibited; co-treatment with weak inhibitors of CYP3A4 is allowed
Use of CYP3A4 inhibitors or inducers and CYP2D6 substrates must be discontinued prior to study entry
Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment, for example:\r\n* Alpha 1-blockers\r\n* Vasodilators, such as nitrates\r\n* Other PDE5 inhibitors, eg, vardenafil, tadalafil\r\n* Therapeutic anticoagulation with vitamin K antagonists (eg, warfarin), heparins and heparinoids, or direct thrombin inhibitors (DTIs)\r\n** Note: prophylactic low-dose anticoagulation to maintain vascular access devices or low-dose daily aspirin for cardiac health is permitted\r\n* Immunosuppressants such as tacrolimus, leflunomide or tofacitinib, roflumilast, pimecrolimus\r\n** Note: administration of steroids as part of symptom management or for other supportive care purposes is permitted\r\n* STRONG CYP3A4 inhibitors and/or STRONG CYP3A4 inducers; \r\n** Note: if such medications have been used, patients must have discontinued these agents >= 2 weeks prior to initiating study treatment
On medications which are CYP3A inhibitors.
Inability to discontinue a prescription or non-prescription drugs or other products known to be metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), or to inhibit or induce CYP3A4 prior to day 1 of dosing and to withhold throughout the study until 2 weeks after the last dose of study medication; medications of particular concern are the following inhibitors of CYP3A4: azole antifungals (ketoconazole itraconazole, fluconazole and voriconazole), macrolide antibiotics (erythromycin, clarithromycin), cimetidine, aprepitant, human immunodeficiency virus (HIV) protease inhibitors, nefazodone and the following inducers of CYP3A4: phenytoin, barbiturates and rifampicin; substrates of CYP3A4 include statins (lovastatin, simvastatin, atorvastatin), midazolam, terfenadine, astemizole, and cisapride
Patients must not have received: cytochrome P450 3A4 (CYP3A4) inhibitors within seven (7) days prior to registration on protocol and for the duration of the study; however, amiodarone, another CYP3A4 inhibitor, should have been discontinued 6 months prior to registration and for the duration of the study
Patient must not have received: CYP3A4 inducers within fourteen (14) days prior to registration and for the duration of the study
Concurrent use of medications/food which may interfere with BMS-813160 including any strong inhibitors or inducers of CYP3A4 or P-gp is not allowed. These include but are not limited to class I antiarrhythmics (eg, quinidine, procainamide, disopyramide, lidocaine, phenytoin, mexiletine, tocainide, flecainide, propafenone, moricizine), grapefruit and seville oranges
Concomitant administration with strong inhibitors or inducers of CYP3A4 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
Current use of a prohibited medication or planned use of any forbidden medications during treatment with GSK525762 and abiraterone/enzalutamide. This includes medications with significant risk of Torsades de pointes as well as those that are potent inducers or inhibitors of CYP3A4 enzymes or strong inhibitors of CYP2C8.
Participants receiving any medications or substances that have antiviral activity against KSHV or that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 19 (2C19) are ineligible; each ART regimen must be reviewed by the PI before determining eligibility to receive nelfinavir mesylate (NFV); sensitive substrates should be avoided; of the antiretroviral drugs, only delaviridine, nevirapine, cobicistat-boosted antiretrovirals (strong CYP3A4 inhibitor), maraviroc (sensitive CYP3A4 substrate), and PIs (strong CYP3A4 inhibitor) are excluded; the following drugs are also prohibited:\r\nStrong Inhibitors of CYP3A4:\r\n* Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin\r\n* HIV: non-nucleoside reverse transcriptase inhibitors (delaviridine, nevirapine), protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir), cobicistat-boosted antiretrovirals (e.g., elvitegravir); NOTE: Clinical trials have demonstrated that there are no clinically significant drug-drug interactions between nelfinavir and the following antiretrovirals: efavirenz (strong CYP3A4 inhibitor), etravirine (strong CYP3A4 inhibitor); therefore, these antiretrovirals will not be excluded\r\n* Antifungals: itraconzaole, ketoconazole, voriconazole, fluconazole, posaconazole\r\n* Antidepressants: nefazodone\r\n* Antidiuretic: conivaptan\r\n* GI: cimetidine, aprepitant\r\n* Hepatitis C: boceprevir, telaprevir\r\n* Miscellaneous: seville oranges, grapefruit, or grapefruit juice and/or pummelos, star fruit, exotic citrus fruits, or grapefruit hybrids\r\nStrong Inducers of CYP3A4:\r\n* Glucocorticoids: cortisone (> 50 mg), hydrocortisone (> 40 mg), prednisone (> 10 mg), methylprednisolone (> 8 mg), dexamethasone (> 1.5 mg)\r\n* Anticonvulsants: phenytoin, carbamazepine, primidone, phenobarbital and other enzyme inducing anti-convulsant drugs (EIACD)\r\n* Antibiotics: rifampin (rifampicin), rifabutin, rifapentine\r\n* Miscellaneous: St. John’s Wort, modafinil\r\nStrong Inhibitors of CYP2C9:\r\n* Antifungals: fluconazole; lists including medications and substances known or with the potential to interact with the CYP3A or 2C19\r\nDrugs with KSHV antiviral activity:\r\n* Participants receiving any medications or substances that may interfere with KSHV replication are ineligible\r\nBecause the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the physicians’ desk reference may also provide this information; as part of the enrollment/informed consent procedures, the participant 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 participant is considering a new over-the-counter medicine or herbal product; lists include medications and substances known or with the potential to interfere with KSHV replication
Consumption of agents which strongly inhibit CYP3A4 enzyme, within 7 days prior to the first dose of study treatment and during the study.
Consumption of agents which strongly induce CYP3A4 enzyme, within 14 days prior to the first dose of study treatment and during the study.
Patients currently receiving medications or herbal supplements of the classes below are ineligible; patients are eligible if they stop use of these compounds at least 1 week prior to receiving any treatment on this protocol\r\n* Potent inhibitors or inducers of CYP3A4 /5 (CYP3A4 inhibitors such as ketoconazole and clarithromycin are not allowed 7 days prior to the first dose of navitoclax and during navitoclax administration)\r\n* Strong or moderate inhibitors of Pgp or BRCP1 \r\n* Sensitive substrates of CYP2C9 (i.e. phenytoin and warfarin)\r\n* Substrates of certain drug transporters (OATP1B1, OATP1B3, MATE1 or MATE2K)
The patient is receiving medications that are:\r\n* Drugs which are exclusively or primarily eliminated by cytochrome P-450 isozyme 3A4 (CYP3A4)\r\n* Drugs which are exclusively or primarily eliminated by UDP-glucuronyl transferase 1A1 (UGT1A1)\r\n* Drugs which are substrates for the drug transporter multidrug resistance protein 1 (MDR1) have a narrow therapeutic window; or which are strong inhibitors of drug transporter MDR1\r\n** Patients should have discontinued strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine) at least five half-lives before beginning study treatment
Concomitant administration with strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) should be avoided; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of; ongoing phenytoin should be either discontinued if clinically safe or transitioned to non-enzyme-inducing antiepileptics like levetiracetam with a 8-day washout period (half-life 18-22 hours, time to steady-state 4-8 days) prior to first dose of VX-970 (7-days prior to WBRT)
Concomitant administration with strong inhibitors or inducers of CYP3A4 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
Has current use (within 7 days of randomization) or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP3A4/5) inhibitors.
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)
Patients on medications known to alter cytochrome P450 3A4 (CYP3A4)
The MMAE component of glembatumumab vedotin is primarily metabolized by CYP3A. Patients taking strong CYP3A inhibitor and inducers are excluded in Phase I (the dose escalation portion), to minimize the effect of these modulators on exposure, tolerability and dose selection.
Patients who are currently receiving treatment (within 7 days prior to starting study treatment) with strong and moderate inhibitors or inducers of CYP3A4/5, substrates of CYP3A4/5 with a narrow therapeutic index or Herbal preparations/medications (Refer to Section 6.4 and Appendix 3) Inclusion Criteria Exceptions for Phase Ib Dose Expansion patients: Dose Expansion part of the study has 3 groups, following are the Inclusion Criteria exceptions for these 3 groups
Requirement for concomitant medications that strongly induce or inhibit CYP3A4/5
RP2D cohort subjects: contraindications to midazolam, any other midazolam within 7 days, or any medications or supplements known to be strong CYP3A inhibitors within 7 days or inducers within 12 days
Patients taking a known moderate to potent inhibitor of CYP1A2 are excluded; pomalidomide is primarily metabolized by CYP1A2 and CYP3A; pomalidomide is also a substrate for permeability (P)-glycoprotein (P-gp)
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)
Patients must not be taking medications that are inducers or inhibitors of CYP3A4; if previously on such an agent, the patient must be off of it for at least two weeks prior to study treatment
Unable or unwilling to discontinue use of strong inducers and inhibitors of CYP450 listed for at least 14 days prior to the first dose of study drug and for the duration of the study; CYP3A4 substrates can be administered, but investigators will need to be aware of possible increased or decreased effectiveness of the non-study drug and this should be recorded in concomitant medications; breast cancer resistance protein (BCRP) and p glycoprotein (PgP) inducers should be used with caution if another alternative drug is not able to be used\r\n* Note: If a medication is incorrectly documented as prohibited in this protocol, documentation from the site pharmacist to the contrary will be acceptable for the purposes of registration
Unable or unwilling to discontinue use of inducers and inhibitors of cytochrome P450 (CYP450) and breast cancer resistance protein (BCRP) and permeability glycoprotein (PgP) inducers and inhibitors listed in the protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study; cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates can be administered, but investigators will need to be aware of possible increased or decreased effectiveness of the non-study drug and this should be recorded in concomitant medications; dexamethasone is acceptable although listed as a CYP3A4 inducers/inhibitors as long as the dose is 16 mg/day or lesser
Patients who previously received CYP3A4 inducers or inhibitors must have discontinued these medications within at least 1 week prior to study entry and can re-start them 1 week post-operatively (or earlier if determined to be of clinical benefit, as determined by the treating physician)
Concomitant use of significant CYP3A4 inhibitors unless able to be switched to a non-CYP3A4 inhibiting medication without risk of worsening underlying condition and able to meet all other inclusion criteria
Patients taking substrates, inhibitors, or inducers of CYP3A4 should be encouraged to switch to alternative drugs whenever possible
Currently taking medication that is substantially metabolized by cytochrome P450 (CYP) 1A2 or CYP3A4 or taking medication known to be strong inhibitors or inducers of CYP3A4
Current (including their administration within 3 days prior to study entry) use or anticipated need for food or drugs that are strong CYP3A4 inhibitors.
Subject uses medication known to be strong inducers of CYP3A4 and CYP2C8 (Section 9.2).
Patients receiving treatment with medications that are known to be 1) strong inhibitors or inducers of CYP3A4/5; 2) CYP2C9 substrate with narrow therapeutic index; 3) QT prolonging agents; 4) proton pump inhibitors unless these medications can be discontinued at least a week prior to start of treatment.
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
Patients must discontinue any medication that causes a strong CYP3A4 inhibition 1 week prior to treatment initiation; patients who are not able to discontinue these drugs are considered ineligible
Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1
Current treatment with medications or consuming foods that are strong inhibitors or inducers of CYP3A4/5 or herbal medications and that cannot be discontinued at least one week prior to the start of treatment.
Contraindicated treatments noted in the product labelling for doxorubicin, including trastuzumab and inhibitors and inducers of CYP3A4, CYP2D6, or P-gp.
Treatment with inducers of cytochrome P450 3A4 (CYP3A4) within 7 days prior to first dose of study treatment
Patients taking CYP3A4 inducers or inhibitors are not eligible since it is not known whether the study drug is metabolized through this pathway. The following CYP3A4 inhibitors/inducers are not permitted during the trial - the azole antifungal - fluconazole, erythromycin, phenobarbital, verapamil.
Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before day 1 and during the study
Treatment with CYP3A inducers within 14 days before the first dose of MLN4924. Treatment with CYP3A inhibitors within 14 days before the first dose of MLN4924; however, voriconazole and fluconazole need only be stopped for 3 days before MLN4924. Patients must have no history of amiodarone use in the 6 months before the first dose of MLN4924
Treatment with strong inducers or inhibitors (medications and herbal supplements) of cytochrome P450 3A4/5 (CYP3A4/5), or CYP3A4/5 substrates with a QT prolongation risk that cannot be discontinued at least 7 half-lives (or if the half-life is unknown,14 days) prior to study drug treatment.
Treatment with CYP3A inducers within 14 days before the first dose of MLN4924
Current or recent (within 6-months) use of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine or strong CYP3A4 inhibitors (i.e. clarithromycin, HIV protease inhibitors, and itraconazole)
Patients receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 or are metabolized by CYP2B6 and CYP2C9, that have narrow therapeutic indices that cannot be discontinued at least 2 weeks before first dose of study treatment and for the duration of the study
Unable or unwilling to discontinue use of strong inducers and inhibitors of CYP450 for at least 14 days prior to the first dose of study treatment and for the duration of the study; CYP3A4 substrates can be administered, but investigators will need to be aware of possible increased or decreased effectiveness of the non-study drug and this should be recorded in concomitant medications; BCRP and PgP inducers and inhibitors should be used with caution if another alternative drug is not able to be used; Note: as this list is constantly evolving, if a medication is incorrectly documented as prohibited in this protocol, documentation from the site pharmacist to the contrary will be acceptable for the purposes of registration
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
Contraindicated: \r\n* CYP2C19 sensitive substrates (unless close monitoring with labs or drug levels with dose adjustments is feasible), inducers, and moderate/strong inhibitors of CYP2C19; patients taking these concurrent medications are ineligible unless they can be switched to alternative medications prior to initiation of the study\r\n* CYP3A4/5 inducers and moderate/strong inhibitors of CYP3A4/5; patients taking these concurrent medications are ineligible unless they can be switched to alternative medications prior to initiation of the study
Concomitant medications that are strong inhibitors of cytochrome P450 and CYP3A up to 14 days before Cycle 1 Day 1 (pimozide, diltiazem, erythromycin, clarithromycin, and quinidine, and amiodarone up to 90 days before)
Crolibulin is a substrate of cytochrome P450 (CYP)2C8, CYP2C9, CYP2C19 and CYP3A4; strong inducers and inhibitors of these enzymes will constitute concomitant medications that are prohibited during the study; these medications include but are not limited to: for CYP2C8, montelukast and trimethoprim, for CYP2C9, lovastatin and sertraline, for CYP2C19, fluoxetine, ketoconazole, pantoprazole, omeprazole, rabeprazole, and ticlopidine, for CYP3A4, itraconazole, clarithromycin, erythromycin, telithromycin, and verapamil
Patients may not be receiving agents thought to inhibit or induce the cytochrome p450 isoenzyme cytochrome P450 3A4 (CYP3A4)
Concomitant use of CYP3A4 inhibitors or inducers;
Require treatment with any known inducers and inhibitors of isoenzyme CYP3A
Patient currently using, or has previously used CYP3A4 inducers or inhibitors within 2 to 14 days prior to the initiation of oral therapy.
Concomitant use of CYP3A4 inhibitors
Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib
Patients taking substrates, inhibitors and inducers of CYP3A4 should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with irinotecan
Patients who need to take CYP3A4 inducers, such as phenobarbital, dexamethasone, carbamazepine, phenytoin, rifampicin, or non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, nevirapine, etravirine) will be excluded; prior use of these agents is acceptable, as long as they are stopped at least a week prior to study entry
Current or anticipated need for drugs that are known cytochrome P450 isozyme CYP3A4 or CYP2C8 inducers or inhibitors; only exception is oral glucocorticoids, which are a required premedication for docetaxel
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.
Clinical requirement for medications that are concurrent inducers or inhibitors of CYP3A4; CYP3A4 substrates are allowed
Use of any drugs or substances known to be inducers of CYP3A4 enzymes within 4 weeks prior to Day 1 or planned to be used during the overall study period.
Women currently taking strong cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inducers or inhibitors; drugs that cannot be coadministered with rapamycin include but are not limited to: calcium channel blockers: nicardipine, antifungal agents: clotrimazole, fluconazole, antibiotics: troleandomycin, gastrointestinal prokinetic agents: cisapride, metoclopramide; other drugs: bromocriptine, cimetidine, danazol, human immunodeficiency virus (HIV)-protease inhibitors (e.g., ritonavir, indinavir), anticonvulsants: carbamazepine, phenobarbital, phenytoin, antibiotics: rifapentine
Current use of: Finasteroid (propecia), Efavirenz, Red Clover, Ketoconazole, CYP3A4 Inhibitors
Exposure to strong inhibitors or inducers of CYP3A4/5, P-glycoprotein (Pgp) (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment; treatment with moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP should be used only if necessary and when alternatives are unavailable; cases should be discussed with the principal investigator
Use of concomitant medications that are known to be strong inhibitors or inducers of CYP3A4 enzyme unless participant can discontinue or switch medications.
Treatment with strong cytochrome P3A (CYP3A) inducers within 14 days before the first dose of pevonedistat. Participants must have no history of amiodarone use within 6 months before the first dose of pevonedistat nor require the use of these medications during the study.
Use of strong cytochrome P3A (CYP3A) inhibitors and CYP3A inducers or inhibitors or modulators of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 1 week before the first dose of study drug.
Subjects taking strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C19 or CYP2C9 within 1 week preceding the first dose of MLN0128 (TAK-228); if a subject requires treatment with strong inhibitors and/or inducers of CYP3A4, CYP2C19 and/or CYP2C9, alternative treatment must be considered; if no alternative is available, one such medication may be allowed after discussing with the study principle investigator
NO treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, or CYP2C19 within 1 week preceding the first dose of study drug
Patients who are currently receiving drugs that are inhibitors or inducers of p-glycoprotein (P-gp) or adenosine triphosphate (ATP)-binding cassette, subfamily G, member 2 (ABCG2 [BCRP]) are not eligible
Treatment with clinically significant enzyme-inducing drugs, including known P-glycoprotein inducers (including St. John’s Wort and rifampicin) should be used only if absolutely necessary and considered to be the best available choice for the patient; if possible, it is recommended that alternatives to known substrates, inhibitors or inducers of P-glycoprotein be considered; cases should be discussed with the principal investigator, and may be allowed as per his/her discretion
For enrollment to the phase 1 portion of the trial: Administration of any cytochrome P450 (CYP)3A inhibitors or inducers within 14 days prior to the first dose of alectinib and from cycle 1 day 1 – cycle 2 day 8 of the phase 1 portion of the trial; following completion of this period, strong/potent cytochrome P450 (CYP)3A inhibitors or inducers are prohibited while on study
Strong P-gp inhibitors or inducers. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ?1 week before dosing and remain off that medication through the end of PK sampling after the administration of the second study treatment
Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C19 or CYP2C9 within 7 days prior to study registration
Taking strong inducers or inhibitors of CYP450s for subjects receiving everolimus
Treatment with any of the strong CYP2C inducers within 14 days before the first dose of TAK-580
Known strong inducers or inhibitors of cytochrome (CYP)3A4 or P-glycoprotein (P-gp);
Administration of strong/potent cytochrome P3A4 (CYP3A4) inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib
Taking a medication known to be clinically significant P-gp inhibitors or inducers within 14 days of treatment with Oratecan.
Taking a medication known to be a clinically significant cytochrome (CYP) 3A4 strong inhibitor (eg, ketoconazole within 14 days) or strong inducers (eg, rifampin and St. John's Wort within 14 days) of starting treatment with Oratecan. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteracti onsLabeling/ucm080499.htm
Concomitant use of strong cytochrome (CYP) inducers or inhibitors including nutraceutical preparations, e.g., grapefruit juice and St John’s wort
Any P-glycoprotein (P-gp) inducers/inhibitors or strong cytochrome P4503A (CYP3A) inhibitors within 14 days prior to the first dose of study drug
Taking known strong cytochrome P450 (CYP) 3A4 inducers, unless they can be transferred to other medications prior to enrolling. For subjects taking AG-120, systemic administration of a moderate or strong CYP3A4 inhibitor requires careful monitoring of the heart rate-corrected QT interval (QTc) using Fridericia's formula (QTcF)
Required use of strong inhibitors and inducers of CYP enzymes and transporters.
Warfarin or other Vitamin K antagonists treatment, strong inhibitors or inducers of cytochrome P450 (CYP)3A4, and drugs with a narrow therapeutic index, which are predominantly metabolized by CYP3A4 and drugs known to have a high risk to prolong QTc as per label.
Subject has used strong cytochrome P450 (CYP) 3A4 inhibitors or inducers such as ketoconazole, rifampin/rifampicin, long acting barbiturates, carbamazepine and St. John's wort in the 5 days prior to the first administration of study drug.
Patients who are currently receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with cyclophosphamide and sirolimus:\r\n* Strong inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp)
Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C9 or CYP2C19 within 1 week preceding the first dose of study drug
Medications known to be clinically significant inhibitors (eg. gemfibrozil) or inducers (eg. rifampin) of CYP2C8 or medications known to be strong cytochrome P450 (CYP) 3A4 inhibitors (eg. ketoconazole) or inducers (eg. rifampin or St. John's Wort). Subjects who are currently taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication 1 week before dosing and remain off that medication during treatment with Oraxol.
Patients who are receiving drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped at least 7 days or 5 half-lives (whichever is longer) before starting treatment with ABC294640 and either replaced with another appropriate medication or not given for the duration of the clinical study
Strong inhibitors or inducers of hepatic microsomal isoenzymes
Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C19 or CYP2C19 within 1 week preceding the first dose of study drug
Systemic treatment with inducers or strong inhibitors of cytochrome P450 within four days before enrollment or planned treatment during the time period of the study.
known to be inducers or inhibitors of P-gp
Medications or supplements that are known to be inhibitors of P-glycoprotein (P-gp) or strong inhibitors or inducers of Cytochrome (CY) P3A 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 drug. In general, the use of these agents is not permitted during the study except for AE management.
**continued from above: Atrial fibrillation documented within 2 weeks prior to first dose of study drug; Patients who require treatment with concomitant drugs that prolong QT/QTc interval or strong CYP3A4 inhibitors or inducers with the exception of antibiotics, antifungals, and antivirals 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 subject.
concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein; Standard criteria:
Subjects to receive duvelisib: Administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A within 2 weeks of starting duvelisib
Concomitant use of P gp inhibitors or inducers or BCRP inhibitors
Strong inhibitors or inducers of cytochrome P450 3A (washout from prior use of such agents before C1D1 must exceed 21 days)
Received the following within 14 days prior to the initiation of study treatment: * Strong CYP2C8 inducers
P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days before the first dose of drug, with the exception of the antibiotics/ antifungals used as prophylaxis and/or supportive care
Treatment with drugs or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 3A4 or cytochrome P450 2C8 within 2 weeks prior to Day 1
Clinically significant drug interactions have been reported when using vincristine with strong cytochrome P450 (CYP450) family 3 subfamily A member 4 (3A4) inhibitors and inducers; selected strong inhibitors of cytochrome P450 3A4 include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John’s wort; the use of these drugs should be avoided with vincristine
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
Patients must not be taking, nor plan to take while on protocol treatment strong P-glycoprotein (P-gp) inhibitors, P-gp inducers, or breast cancer resistance protein (BCRP) inhibitors
Patients who were receiving drugs that were sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that could not have been stopped at least 7 days or 5 half-lives (whichever was longer) before starting treatment with ABC294640, could not have been replaced with another appropriate medication or not given for the duration of the clinical study. (A list of commonly used drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes with the half-life of each drug identified, is included in Appendix 3)
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
Treatment with medications that are known to be strong inhibitors or inducers of CYP450 enzymes.
Treatment with strong cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days before the first dose of study drug.
Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-gp with the exception of drugs that are considered absolutely essential for the care of the subject.
Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on 1 these treatments)
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
Has plans to use, or is using, any herbal medications/supplements or any medications or foods that are strong inhibitors or inducers of cytochrome P450 3A 4/5 ?1 week prior to the start of study treatment
Participants chronically receiving strong cytochrome P450 3A4 (CYP3A4)/P-glycoprotein (P-gp) inhibitors or inducers within 7 days prior to study enrollment
HIV-positive patients requiring antivirals which are cytochrome P450 (CYP) interactive with the investigational agents (CYP3A4/5 strong inducers and inhibitors)
Administration of the cytochrome P450 (CYP)3A4 inducers or inhibitors, as they may induce or inhibit irinotecan or SN38 metabolism within 14 days prior to cycle 1 and throughout study treatment
Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in participants receiving ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) with and without dasabuvir (DSV), strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2-direct-acting antiviral agent (2-DAA) and 3-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.
Concomitant treatment with strong inhibitors or inducers of P-glycoprotein (P-gp)
Treatment with drugs or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 3A4 or 2C8 within 2 weeks prior to Day 1
Receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP450 3A4); \r\n* NOTE: oxidative metabolism of MK-2206 in human liver microsomes is catalyzed primarily by CYP3A4, although direct glucuronidation also occurs; at least 7 days washout period is required in patients who were previously taking strong inhibitors or inducers of CYP.450 3A4; patients who are currently taking moderate inhibitors or inducers of CYP450 3A4 are encouraged to switch to other medications that do not interact with CYP450 3A4
No concurrent cytochrome P450 3A4 inducers
No concurrent strong cytochrome P450 3A4 inhibitors
Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C19 or CYP2C19 within 1 week preceding the first dose of study drug
Treatment with medications that are known to be strong inhibitors or inducers of CYP450 enzymes
Subject who has received strong or moderate inhibitors (e.g., ketoconazole or fluconazole) or inducers (e.g., rifampin or phenytoin) of cytochrome P450 (CYP)3A4 or of P-glycoprotein (P-gp), or substrates of multidrug and toxin extrusion (MATE)1 with the exception of antibiotics, antifungals, and antivirals that are used as standard of care post transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject within 2 weeks prior to start of study treatment and while on study.
Strong Inhibitors of CYP2D6
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of Cytochrome P450-isozyme3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject
Patients who have been exposed to medications, herbal preparations, or foods known to be predominant Cytochrome P450 2C9, 2C19, 2D6, 3A4/5 substrates, strong inhibitors or inducers within 7 days of planned first study treatment day
Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) family 3A4, CYP2C9 or CYP2C19 within 1 week preceding the first dose of study drug
Received medications, supplements, or food/beverages that are P-glycoprotein (P-gp) inhibitors or inducers or strong cytochrome P450 (CYP) 3A inhibitors or inducers within a certain timeframe prior to the first dose of study drug. Depending on the substance, the washout period for P-gp inhibitors or inducers or strong CYP3A inhibitors or inducers will be either 7 days or 5 times the half-life (half-life is related to the time required for elimination from the body). The washout period for grapefruit containing food or beverages is 5 days.
Medications or supplements that are known to be inhibitors of P-glycoprotein (P-gp) and/or strong reversible inhibitors of cytochrome P450 (CYP) 3A 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 drug. In general, the use of these agents is not permitted during the study except in cases in which an AE must be managed. See a nonexhaustive list of prohibited strong CYP3A reversible inhibitors and/or P-gp inhibitors based on the US Food and Drug Administration (FDA) Draft Drug-Drug Interactions (DDI) Guidance.
Condition requiring treatment with strong inhibitors/inducers of cytochrome p450 (CYP) 3C4 within 7 days prior to first dose of chemotherapy (requirement applies to subjects enrolled to Part 2 chemotherapy combination with docetaxel).
DONOR: Concurrent treatment with strong inhibitors of hepatic cytochrome P450 (CYP) 3A4 (i.e. clarithromycin, erythromycin, protease inhibitors, azole antifungals)
DONOR: Concurrent treatment with strong inhibitors of hepatic CYP 3A4 (i.e. clarithromycin, erythromycin, protease inhibitors, azole antifungals)
Treatment with medications that are known to be strong inhibitors or inducers of CYP450 enzymes
Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
Patients who are receiving strong CYP450 inducers or inhibitors are ineligible
Require treatment with inducers or inhibitors of cytochrome P450 (CYP)1A2, CYP2C9, CYP2D6, and CYP3A within 14 days before the first dose of study drug through the end of Period 2
Medications or supplements that are known to be inhibitors of P-glycoprotein (P-gp) and/or strong reversible inhibitors of cytochrome P450 (CYP) 3A within 5*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 drug.
Medications or supplements that are known to be inhibitors of P-glycoprotein (P-gp) and/or strong reversible inhibitors of cytochrome P450 (CYP) 3A 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 drug. In general, the use of these agents is not permitted during the study.
No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined
Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or CYP3A4 inducers
Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study
Patients who have taken medications that are known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) within 28 days prior to registration are NOT eligible for participation
Of the five major cytochrome P450 (CYP) isoforms, 3A4 (BFC) may be involved in Phase I metabolism of PLX3397, with possibly cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) playing a minor role; until information regarding exposure toxicity and exposure-response relationships are available with PLX3397, concomitant strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and inducers are not permitted in the event they alter the systemic exposure to PLX3397; these include anticonvulsants, mycin antimicrobials, and antiretrovirals; some common examples include inhibitors such as erythromycin, fluoxetine, gemfibrozil, and inducers such as rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine; concomitant treatment is permitted if the medication is not expected to interfere with the evaluation of safety or efficacy of the study drug; during the study, if the use of any concomitant treatment becomes necessary (e.g., for treatment of an adverse event), the treatment must be recorded on the electronic case report form (eCRF), including the reason for treatment, generic name of the drug, dosage, route, and start and stop dates of administration; sirolimus undergoes extensive hepatic and intestinal metabolism via CYP3A4 and cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A5), as well as excretion by permeability (P)-glycoprotein; strong CYP3A inhibitors such as ketoconazole or grapefruit juice are not permitted; patients should be monitored for supratherapeutic toxic levels of sirolimus and PLX3397; as bone marrow suppression including anemia, neutropenia, and thrombocytopenia have been reported in patients receiving sirolimus monotherapy, these adverse effects may be exacerbated in combination with PLX3397 for which patients will be closely monitored
Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (3A4/5); (a one-week wash-out period is necessary for patients who are already on these treatments)
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers unless able to stop medication(s) prior to starting study treatment
EXCLUSION CRITERIA FOR REGISTRATION: Currently taking medications and herbal or dietary supplements that are strong cytochrome P450 (CYP) family 3, subfamily A, polypeptide 4 (3A4) inducers or inhibitors; a washout period of at least 5 days is required and must have been completed prior to the start of neratinib if the patient was taking any of these agents; if unavoidable, patients taking CYP3A4 inhibitors should be monitored closely
Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with INC280 and for the duration of the study:\r\n* Strong and moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)\r\n* Strong inducers of CYP3A4\r\n* Proton pump inhibitors (PPI)
Is chronically taking a strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A) inhibitor or inducer and cannot be switched to an alternative agent at least 7 days prior to idelalisib or ibrutinib initiation that in the opinion of investigator/treating physicians precludes utilization of either Ibrutinib or Idelalisib; caution is recommended for patients taking moderate inhibitors of CYP3A
Patients who are taking medications that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or phosphoglycolate phosphatase (PgP) and need to remain on these medications
As ibrutinib is extensively metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), and patients must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5
Patients who are receiving drugs that are strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers unless able to stop medication(s) prior to starting study therapies
Current use or anticipated need for food or drugs that are known moderate/strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers, with the exception of azole antifungals, which are permitted
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers are not permitted
Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; investigator can change to a similar agent that is a non-CYP3A4 inhibitor/inducer with a washout period of 1 week
Patients receiving any medications or substances that are potent inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) isoenzymes within 7 days of randomization for list of CYP3A inhibitors and inducers
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
Requires chronic treatment with strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Use of strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers
Require treatment with strong cytochrome P450 family 3 subfamily A (CYP3A) inhibitors
Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) are prohibited
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Requires treatment with a strong cytochrome P450 modulators (cytochrome P450, family 3, subfamily A [CYP3A] inhibitor and/or CYP3A inducers)
Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Patients receiving any medications or substances that are strong inhibitors of cytochrome (CY)P450 family 3 subfamily A polypeptide 4 (3A4) isoenzyme
Patients who would be required to concurrently take ruxolitinib in conjunction with a strong cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and have a platelet count less than 100,000 are ineligible for the study
PHASE I: Concomitant use of known potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Administration of strong/potent cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib except for oral corticosteroids up to 20 mg of prednisone equivalent per day
Need for concurrent treatment with medications that strongly interact with everolimus (cytochrome P450 family 3 subfamily A member 4 [CYP3A4] inducers or inhibitors)
Subject takes cytochrome P450, family 3, subfamily A (CYP3A) inhibitors/inducers within 7 days prior to the study drug administration
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; strong inhibitors and inducers of UGT/PgP should be used with caution
Requires treatment with strong cytochrome P450, family 3, subfamily A (3A) (CYP3A) inhibitors
Patients requiring strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Inducers and Inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4): patients required to be on any CYP3A4/5 inhibitors or inducers will be excluded (with the exception of dexamethasone, but all efforts should be made to reduce the dose of dexamethasone); patients must discontinue drug at least 7 days prior to starting dasatinib
Planned ongoing administration of STRONG cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
Concomitant use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
Patients taking medications or herbal supplements that are known to be strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors within at least 14 days prior to registration are excluded
Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Use of a strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor less than 14 days prior to initiation of study treatment
Patients taking any medications or substances that are inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A)
Patients who are receiving treatment with medications known to be strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5 or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting study treatment with sonidegib\r\n* Note: if patients can stop receiving these medications, strong CYP3A4/5 inhibitors should be discontinued at least 7 days prior to starting study treatment with sonidegib and strong CYP3A/5 inducers should be discontinued at least 2 weeks prior to starting study treatment with sonidegib
Relapsed/refractory MCL: Requires treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) inhibitors
Exclude persons who require ongoing administration of STRONG cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or STRONG CYP3A4 inducers and/or STRONG cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) inhibitors
Unable to discontinue use of potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors/inducers
Patients that are taking cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and/or inhibitors; if a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the protocol, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on protocol
Taking any medications or herbal supplements that are known to be strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) within at least 14 days before the first dose of ponatinib
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); use of the strong or moderate inhibitors are prohibited =< 7 days prior to registration
Chronic concomitant treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors is not allowed; patients must discontinue the drug >= 14 days prior to registration
Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
Concomitant medications:\r\n* Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098\r\n* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment for patients with NF2 mutation enrolled to GSK2256098
VX-970 is primarily metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); therefore, concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided
Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (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
Requiring potent cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors
Patients on cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CPY450 3A4); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration:\r\n* Strong inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4): indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin\r\n* Moderate inhibitors of CYP3A4: aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP450 CYP2C8); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration\r\n* Strong or moderate inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8): gemfibrozil, trimethoprim
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP450 CYP2C9); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration\r\n* Strong or moderate inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9): fluconazole, amiodarone
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A) isoenzymes should be ineligible
Use of strong cytochrome P450 family 3 subfamily A member 4 (3A4) (CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the start of study treatment
Subjects must be willing and able to come off any proton pump inhibitor (PPI)/other strong cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inhibitors or inducers/simvastatin
Patients must NOT be taking current medications or substances that are inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4)
Subjects taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) and cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) inhibitors and/or inducers should be considered with caution; alternative treatments that are less likely to affect MLN0128 metabolism, if available, should be considered; if a subject requires treatment with 1 or more of the strong CYP3A4 and CYP2C19 inhibitors and/or inducers, the principal investigator should be consulted
Patients who are on concomitant medications that are STRONG inducers or inhibitors of the cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) enzyme should stop 2 weeks prior to first dose of dasatinib, if all other eligibility has been confirmed
Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (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 who are taking concomitant medications that in the investigator’s opinion are strong inducers of the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) enzymes and therefore likely to interact with the study agents, will not be eligible
Patient currently receiving any drugs considered to be strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors which cannot be discontinued or changed to an alternative drug prior to enrolling on the trial
Patients on potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and inhibitors
Co-administration with strong inhibitors of cytochrome P450, family 3, sub family A, polypeptide 4 (CYP3A4) (e.g., ketoconazole, itraconazole, ritonavir) or P-glycoprotein (PgP)
Patients taking medications known to be strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Subjects who require therapy with a strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor prior to enrollment to this study
Patients who are currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzymes cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP34A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8); the patient must have discontinued moderate and strong inducers of both enzymes for at least one week and must have discontinued strong and moderate inhibitors before the start of treatment; switching to a different medication prior to start of treatment is allowed
Use of a strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor less than 14 days prior to initiation of study treatment
Chronic concomitant treatment of strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or CYP3A4 inhibitors
Not receiving any medications or substances that are strong inhibitors of cytochrome P450 family 2, subfamily D, polypeptide 6 (CYP2D6)
Concomitant use with strong or moderate cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/P-glycoprotein (PgP) inhibitors and CYP3A4/PgP inducers
SUB-PROTOCOL AIM A: Receiving any concomitant antitumor therapy or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Patients who require treatment with strong cytochrome P450 family 3, subfamily A (CYP3A) inducers
Requirement for chronic use of medications known to be strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) iso-enzymes; Note: if patients can stop receiving these medications, CYP3A4 inhibitors should be discontinued at least 7 days prior to starting treatment with G-202
Any medications which are strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers
Concurrent use of drugs that are known to be moderate or strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or inducers or drugs that are known to prolong the QT interval
Concomitant use of strong inhibitors of the cytochrome p450, family 3, subfamily a, polypeptide 4 (CYP3A4) isoenzyme is not permitted; must have wash-out period of 5 times the half-life of the compound before first dasatinib dose
Patients on strong cytochrome p450 family 3 superfamily A (CYP3A) inducers or inhibitors that are unable to be discontinued
Inability or unwillingness to abstain from taking any medications or herbal supplements that are moderate or strong inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) at least 1 week prior dosing with AZD1775 and while on study treatment
Patients who are currently receiving treatment (within 5 days prior to starting study drug) with agents that are known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A polypeptide 5 (5), or that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or moderate inhibitors of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
Patients requiring any medications or substances that are strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or clinically significant enzyme inducers of CYP3A4 are ineligible
Requires treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Requires treatment with strong cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) inhibitors
Taking any medications or herbal supplements that are known to be strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) =< 14 days prior to registration
Patients who are taking strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors, and/or CYP3A4 inducers
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); use of strong or moderate inhibitors are prohibited =< 7 days to registration
Foods or medications that are strong or moderate inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) taken within 1 week prior to study treatment and for the duration of the study
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) or drugs metabolized by cytochrome P450 family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 5 (5) or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A4/5 inducers for at least 2 weeks prior to starting treatment with LDE225; NOTE: patients who are already on or require initiation of azoles other than fluconazole will be excluded from the phase I dose escalation portion of the study
Women currently taking drugs which are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are not eligible
Use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
PHASE I: Participants receiving any medications or substances that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A) isoenzymes are ineligible
Concurrent use with strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors/inducers is prohibited; moderate CYP3A4 inhibitors/inducers should be used with caution
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Concomitant use of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors at time of screening; if use of CYP3A4 inhibitors becomes medically necessary during study, they must be used with caution
Required, chronic, use of drugs that are strong inhibitors or inducers of cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Patients receiving any medications or substances that are strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) are ineligible
PART B: Ponatinib is a substrate for cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), concurrent use with potent CYP3A4/5 inhibitors or inducers should be undertaken with caution
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)\r\n* Use of strong or moderate inhibitors is prohibited =< 7 days prior to registration
Patients may not be receiving concurrent therapy with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or strong inhibitors or inducers of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8); please note that concurrent use of trimethoprim, a component of Bactrim, is prohibited per protocol; patients who require pneumocystis carinii pneumonia (PCP) prophylaxis will need to switch to an alternative antibiotic (e.g. Mepron)
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible\r\n* For patients on intermediate inducers or inhibitors, attempts should be made to switch to an alternative agent or delay enrollment until treatment course with concomitant agent completed; if not possible, patient may be enrolled if it is felt to be in the patients best interest as decided by the investigator\r\n* Weak inhibitors of CYP3A or CYP2C8 should be used with caution and attempts made to limit their use or find alternative agents, if possible
At the time of registration, patients must not be receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8); patients must not be planning to use herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1)
Concurrent administration or received cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors within 2 weeks prior to the first day of study drug treatment
Patients unwilling or unable to refrain from use of moderate or strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A)
Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this trial; patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to the start of study treatment
Patients receiving any medications or substances that are strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; moderate inducers of CYP3A4 should be used with caution
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) complex are ineligible
Concomitant use of any drug which is a moderate or strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor or strong CYP3A4 inducer
Concurrent therapy with strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) due to concerning possible drug-drug interactions with abiraterone
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Individuals receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) enzyme(s) are eligible only if principal investigator approves subject enrollment prior to registration; participants who have received a medication or substance listed may be enrolled on study as long as they have discontinued its use at least 48 hours prior to registration
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450, family 3, sub family A polypeptide 4/5 (CYP3A4/5) or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with erismodegib; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with erismodegib
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A5) or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with sonidegib; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with sonidegib
Concomitant medications listed are prohibited; inhibitors or inducers of cytochrome P450, family 3, subfamily, polypeptide 4 (CYP3A4) not listed can be used with caution
Patients taking medications known to be strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Concomitant use of strong or moderate cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Participants receiving any medications or substances that are strong/intermediate inhibitors or inducers of cytochrome P450 (CYP450) cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) are ineligible
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
Patients requiring chronic treatment with strong cytochrome P450 family 3, subfamily A (CYP3A) inhibitors cannot be treated with ibrutinib but idelalisib would be an option
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) are ineligible
Planned use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or CYP3A4 inducers while on study treatment unless deemed clinically necessary with no reasonable alternatives and with expressed permission from the principal investigator
Patients who are currently on or have used potent or moderate inhibitors or strong inducers cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or p-glycoprotein (PgP) inhibitors in the past 2 weeks
Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this trial; patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to the start of study treatment
Subjects have received potent cytochrome P450, family 3, subfamily A (CYP3A) inhibitors within 7 days prior to the initiation of study treatment
Cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) strong or moderate inhibitors/inducers in the past 7 days
Use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors within 2 weeks of starting study medication
Strong inducers and inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), and therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids is not allowed on the study
Systemic exposure to ketoconazole or other strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) isoenzyme inhibitors or inducers within 14 days prior to the start of study treatment; systemic exposure to aminodarone is not allowed within 1 year prior to the start of study treatment
Patients taking concomitant medications (chronically or within 1 week of study drug administration) which are strong inhibitors of hepatic metabolism via cytochrome P450 (P450)/cytochrome P450, family 3, subfamily A, polypeptide 4 (CY3PA4) isoenzyme will be excluded
Concurrent use of moderate to strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors is not allowed
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
Patients taking moderate/strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) or drugs metabolized by cytochrome P450 family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225
Concomitant use of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Patients currently receiving strong or moderate cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers; patients should not begin study drugs until at least 72 hours after the last dose (or longer) of the inhibitor or inducer
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) or with drugs metabolized by cytochrome 450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome 450 family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers should be discontinued for at least 14 days prior to starting treatment with LDE225
Taking any of the following agents:\r\n* Chronic treatment with systemic steroids or another immunosuppressive agent\r\n* Live vaccines \r\n* Drugs or substances known to be inhibitors or inducers of the isoenzyme cytochrome P450 family 3, subfamily A (CYP3A)
Receiving treatment with any potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors within 7 days of the first dose of study drug
Receiving any medications or substances that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5)
Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A)
Patient is taking a drug known to be a moderate and strong inhibitor or inducers of the P450 isoenzyme cytochrome P450, family 3, subfamily A (CYP3A); participants must be off P450/CYP3A inhibitors and inducers for at least two weeks prior to starting the study drug
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Patients who are receiving treatment with medications known to be strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have a narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225; note that patients who require anti-fungal prophylaxis are preferred to be on fluconazole, and, patients taking voriconazole or posaconazole who must continue are excluded from the dose escalation phase of the study; once the maximum tolerated dose (MTD) is established, patients taking voriconazole or posaconazole will be allowed to enroll but at a dose adjustment to be determined before the expansion phase opens
Concurrent use of medications that are strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors within 14 days prior to registration for protocol therapy; NOTE: concurrent use of other CYP3A4 inhibitors may be allowed at the discretion of the treating physician or principal investigator
Concomitant use of dual strong inhibitors or inducers (cytochrome P450, family 3, subfamily A, polypeptide 4 [CYP3A4], P-glycoprotein [P-gp])
Drugs with potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and inducers should be avoided during the course of treatment
Patients who are taking medications that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or permeability (P)-glycoprotein (PgP) and need to remain on these medications
Required administration of concomitant moderate or strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) for 14 days prior to the first dose of study drug; prior amiodarone for up to 6 months prior to day 1 of study treatment
Participants are to discontinue the use of the following classes of inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); patients who are on these drugs are eligible if a washout period of a minimum of 7 days occurs before start of olaparib and temozolomide:\r\n* Azole antifungals\r\n* Macrolide antibiotics\r\n* Protease inhibitors
Patients taking substrates, inhibitors, or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with irinotecan
Concurrent therapy with strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) due to concerning possible drug-drug interactions
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
Caution should be exercised when dosing navitoclax concurrently with cytochrome P450, family 2, subfamily C, peptide 8 (CYP2C8) and cytochrome P450, family 2, subfamily C, peptide 9 (CYP2C9) substrates; common CYP2C8 substrates include paclitaxel, statins, and glitazones, whereas CYP2C9 substrates include phenytoin; when possible, investigators should switch to alternative medications or monitor the patients closely; cytochrome P450, family 3, subfamily A (CYP3A) inhibitors such as ketoconazole and clarithromycin are not allowed 7 days prior to the first dose of navitoclax or during navitoclax administration
Treatment with strong cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19), cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), and cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) inhibitors and/or inducers must be discontinued at least 1 week before administration of the first dose of study drug
Patients receiving any medications that are known to be strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), or sensitive substrates of CYP3A4, cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2), cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) or permeability glycoprotein (P-gp) with a narrow therapeutic index
Patients currently receiving (or unable to stop use at least 1 week prior to receiving the 1st dose of AZD9291) medications or herbal supplements known to be potent inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; patients are eligible if they stop use of these compounds at least 1 week prior to receiving any treatment on this protocol
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2), CYP1A3, cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), CYP2C19, cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), UDP glycosyltransferase 1 family, polypeptide A1 (UGT1A1), P-glycoprotein, or breakpoint cluster region pseudogene (BCRP) 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
Concomitant therapy with any drugs shown to have major interactions with nortriptyline (i.e. known inhibitors of cytochrome P450 family 2 subfamily D member 6 [CYP2D6]) and use during the 30-day period prior to study start
Drugs that affect the cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) systems are allowed but should be used with caution depending on specific kinase inhibitor used
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with ceritinib and for the duration of participation:\r\n* Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes\r\n* Strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5)\r\n* Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, and/or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9)\r\n* Therapeutic doses of warfarin sodium (Coumadin) or any other Coumadin-derived anti-coagulant; anticoagulants not derived from warfarin are allowed (e.g., dabigatran, rivaroxaban, apixaban)\r\n* Unstable or increasing doses of corticosteroids; if patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms (non-central nervous system [CNS]), dose must have been stabilized (or decreasing) for at least 5 days before first dose of study treatment\r\n* Enzyme-inducing anticonvulsive agents\r\n* Herbal supplements
Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) subfamily IIIA, polypeptide 4 (3A4), cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) or cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) within 1 week preceding the first dose of study drug
Concomitant use of medications that are known cytochrome p450 family 3 subfamily A member 4 (CYP3A4) substrates
Nonclinical studies indicate that DS-3032b is metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5; drugs that are strong inhibitors or inducers of these enzymes may alter the PK of DS-3032b and should therefore be avoided; St. John’s wort (hypericin) will not be permitted for 30 days before and during participation in the study; foods or beverages containing grapefruit should not be taken within 48 hours before initial dose of study drug and throughout the duration of the study
Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin) are ineligible; patients on strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors will also be excluded
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with ceritinib and for the duration of participation:\r\n* Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes\r\n* Strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 4 (5)\r\n* Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and/or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) \r\n* Therapeutic doses of warfarin sodium (Coumadin) or any other Coumadin-derived anti-coagulant\r\n* Anticoagulants not derived from warfarin are allowed (eg, dabigatran, rivaroxaban, apixaban)\r\n* Unstable or increasing doses of corticosteroids; if patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms (non-central nervous system [CNS]), dose must have been stabilized (or decreasing) for at least 5 days before first dose of study treatment\r\n* Enzyme-inducing anticonvulsive agents\r\n* Herbal supplements
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors where the interaction is thought too great to proceed with romidepsin
Any concomitant potent inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Are taking strong or moderate cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inducers, or CYP3A4, cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) and cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) substrates with a narrow therapeutic index; patients may switch to an alternative any time prior to day 1 of trial drug administration
Concomitant use of strong inhibitors (e.g., ketoconazole, nefazodone, clarithromycin, gemfibrozil) or strong inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St John’s wort) of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8)
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with ceritinib and for the duration of the study participation: \r\n* Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes \r\n* Strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4/cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A4/5)\r\n* Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and/or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) \r\n* Therapeutic doses of warfarin sodium (Coumadin) or any other Coumadin-derived anti-coagulant; anticoagulants not derived from warfarin are allowed (e.g., dabigatran, rivaroxaban, apixaban)\r\n* Unstable or increasing doses of corticosteroids\r\n* Enzyme-inducing anticonvulsive agents \r\n* Herbal supplements
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with ceritinib and for the duration of participation\r\n* Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes \r\n* Strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) \r\n* Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and/or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) \r\n* Therapeutic doses of warfarin sodium (Coumadin) or any other Coumadin-derived anti-coagulant; anticoagulants not derived from warfarin are allowed (eg, dabigatran, rivaroxaban, apixaban)\r\n* Unstable or increasing doses of corticosteroids; if patients are on corticosteroids for endocrine deficiencies or tumor-associated symptoms (non-central nervous system [CNS]), dose must have been stabilized (or decreasing) for at least 5 days before first dose of study treatment\r\n* Enzyme-inducing anti-convulsive agents\r\n* Herbal supplements
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with ceritinib and for the duration of participation:\r\n* Medication with a known risk of prolonging the QT interval or inducing torsades de pointes \r\n* Strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5 \r\n* Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and/or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) \r\n* Therapeutic doses (defined as doses need to achieve target INR > 1.5) of warfarin sodium (Coumadin) or any other Coumadin-derived anti-coagulant; anticoagulants not derived from warfarin are allowed (e.g., dabigatran, rivaroxaban, apixaban)\r\n* Unstable or increasing doses of corticosteroids\r\n* Enzyme-inducing anticonvulsive agents\r\n* Herbal supplements
Patients who are currently receiving treatment with agents that are metabolized solely through cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) and have a narrow therapeutic index or are strong cytochrome P450 family 3, subfamily C, polypeptide 8 (CYP2C8) inhibitors; or are receiving treatment with agents that carry a risk for QT prolongation and are CYP3A substrates
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 5 (5) or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225
Caution should be exercised when dosing navitoclax concurrently with cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) substrates; common CYP2C8 substrates include paclitaxel, statins, and glitazones, whereas CYP2C9 substrates include phenytoin and warfarin; when possible, investigators should switch to alternative medications or monitor the patients closely (particularly in the case of medications that have a narrow therapeutic window such as warfarin; use of warfarin is specifically prohibited while on study); cytochrome P450, family 3, subfamily A (CYP3A) inhibitors such as ketoconazole and clarithromycin are not allowed 7 days prior to the first dose of navitoclax or during navitoclax administration; 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; patient instructions and information of possible drug interactions will be given to all patients upon enrollment in this study
The following medications are prohibited during the study: \r\n* Substrates of cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6), cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8), cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), and cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) with a narrow therapeutic index, including paclitaxel, phenytoin, warfarin, omeprazole \r\n* Substrates of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) with a narrow therapeutic index, including alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus\r\n* Strong CYP2C8 inhibitors, including gemfibrozil\r\n* Strong CYP3A4/5 inhibitors, including clarithromycin, itraconazole, ketoconazole
Strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 3A4) inhibitors (e.g., clarithromycin, human immunodeficiency virus [HIV] protease inhibitors, and itraconazole), given potential interactions with atorvastatin (atorvastatin calcium)
Concomitant use of drugs that are cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), cytochrome P, family 1, subfamily A, polypeptide 2 (CYP1A2), or cytochrome P, family 2, subfamily D, polypeptide 6 (CYP2D6) substrates
Drugs that affect the cytochrome P450 family 3 subfamily A polypeptide 4 (CYP3A4) system (inducers/inhibitors/substrates) are allowed but should be used with caution depending on specific kinase inhibitor used; dietary supplements will be discouraged; however, their use may be allowed on a case by case basis per the discretion of the investigator after consultation with an oncology pharmacist
Patients on drugs that are strong cytochrome P450, family 3, subfamily A, polypeptide 4 (P450 CYP3A4) modifiers; these drugs should be stopped 5 half-lives prior to starting investigational agents with temsirolimus; the strong inducing or inhibiting agents should not restart until 1 week after the end of the study treatment; NOTE: we will allow replacement of steroids (with either prednisone or hydrocortisone) in patients with adrenalectomy
Use of St. John’s wort, orrifampin (rifampicin), or other strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers; dexamethasone is okay as long as the dose is 16 mg /day or less\r\n* Note: patients who are on the above referenced medications may be considered eligible with a washout period of 14 days; contact the coordinating center to discuss patients with the above aforementioned agents before patient registration
Treatment with drugs that are substrates of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6), and cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) except for the ones that are explicitly permitted; prohibited medications include but are not necessarily limited to alfuzosin, amiodarone, astemizole, bepridil, “Chinese” (herbal) medicines, cisapride, cyclosporine, cyclophosphamide, desipramine, erythromycin, etoposide, fentanyl, flecainide, flutamide, grapefruit and grapefruit juice, halofantrine, ifosfamide, imipramine, lovastatin, mexiletine, modafinil, oxycodone, pimozide, propafenone, quetiapine, quinidine, simvastatin, tacrolimus, tamoxifen, terfenadine, thioridazine, vinblastine and vincristine; exception: those patients who are in the translational sub-study will receive a low dose of fentanyl (a substrate of CYP3A4) during the surgical procedure (100-200 mcg) for pain, along with ultra-short acting remifentanil (the latter has 8-10 min half-life)
Patients who are receiving drugs that significantly interact with the cytochrome P450 (CYP450) enzyme(s) are ineligible; however, if they are switched to other medications with a 2-week washout window, they will be eligible; patients are also excluded if they have been exposed within 7 days of planned first study treatment day to medications that are predominantly cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6), cytochrome P450, family 2, subfamily C, polypeptide 9 (2C9) or cytochrome P450, family 2, subfamily C, polypeptide 19 (2C19) substrates, strong inhibitors or inducers, and sensitive substrates of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) with narrow therapeutic range
Chronic concomitant treatment with strong cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors is not allowed; patients must discontinue the drug >= 14 days prior to registration
Drugs that strongly inhibit or potentiate cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4):\r\n* During Phase I: patients who have received these drugs within 14 days or within 5 half-lives of the drug (whichever is longer) prior to study initiation will be excluded\r\n* During Phase II: these drugs should be avoided if possible
Less than 1 week since prior treatment (most recent dose) with a potent cytochrome P450 family 3, subtype A, polypeptide 4 (3A4) (CYP3A4) inhibitor
Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible (e.g. gemfibrozil, rifampin, trimethoprim, pioglitazone)
In vitro data indicate that GSK2141795 is a cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrate; drugs that potently inhibit CYP3A4 could lead to increased GSK2141795 exposure in subjects, and should either be prohibited or used with caution; drugs which are strong inducers of cytochrome P450, family 3, subfamily A (CYP3A) and may result in lower exposures of GSK2141795 should also be prohibited; GSK2141795 also appears to be a moderate in vitro inhibitor of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) (50% inhibitory concentration [IC50] 3 mcM) and CYP3A4 (IC50 11 mcM); drugs that are substrates of CYP3A4 or CYP2C8 with a narrow therapeutic index may be prohibited; drugs that are sensitive substrates of CYP3A4 or CYP2C8 should be used with caution
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
The eligibility of patients taking medications that are potent modulators of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6), subfamily 2, polypeptide 8 (2C8) 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
Evaluation of the patient’s medications within 10 days prior to registration with attempt to change any medication that affects cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Certain medications that act through the cytochrome P450 (CYP450) system are specifically prohibited in patients receiving pazopanib and others should be avoided or administered with extreme caution\r\n* Strong inhibitors of CYP3A4 such as ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole may increase pazopanib concentrations and are prohibited; although, in exceptional circumstances, they may be administered in conjunction with lowering the dose of pazopanib by 50% of what would otherwise be administered; grapefruit juice is also an inhibitor of CYP450 and should not be taken with pazopanib\r\n* Strong inducers of CYP3A4, such as rifampin, may decrease pazopanib concentrations, are strictly prohibited\r\n* Medications that have narrow therapeutic windows and are substrates of CYP3A4, cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6), or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) should be avoided and, if necessary, administered with caution
Prohibited medications: PKC412 and its two major metabolites may have a potential of drug-drug interactions with P-gp substrates and cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors, and inducers; an increased anticoagulant effect has been noted in patients treated with warfarin and midostaurin
As PF-02341066 is an inhibitor of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), patients chronically receiving medications known to be metabolized by 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
Potent cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors, such as ketoconazole and erythromycin, should be avoided during the study treatment period with T-DM1
Patients taking substrates, inhibitors and inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) should be encouraged to switch to alternative drugs whenever possible
Patients that have been treated with strong cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors, CYP2C8 inducers, within 2 weeks of starting the trial treatment.
Current or anticipated need for treatment with drugs that are known substrates of cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6)
Patients currently taking the following medications:\r\n* Cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors (e.g. Gemfibrozil)\r\n* CYP2C8 inducers (e.g. rifampin)\r\n* Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (itraconazole)\r\n* CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine)
Finasteroid (propecia), efavirenz, red clover, ketoconazole and other drugs that are cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Treatment with strong cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19), cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), and cytochrome P450 family 2 subfamily C member 9 (CYP2C9) inhibitors and/or inducers must be discontinued at least 1 week before administration of the first dose of study drug
Able to stop all cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (voriconazole or posaconazole) at least 7 days before admission
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 medications that may alter pharmacokinetics of crizotinib or enzalutamide; would exclude the use of strong cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors, strong or moderate CYP3A inducers, CYP2C8, cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) and cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) substrates with narrow therapeutic indices
Concomitant use of narrow therapeutic index drugs that are metabolized by cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) (i.e. alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) (phenytoin, warfarin), and cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19) (S-mephenytoin); (Note: patients on stable doses of anti-coagulation with warfarin and fentanyl will be eligible, as long as they are monitored closely with additional international normalized ratio [INR] monitoring)
Mifepristone inhibits cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) and induces CYP3A4; addition of mifepristone to a pre-existing drug regimen may cause a mild and temporary increase in plasma drug concentration of drugs with significant CYP3A4 metabolism; medications that are strong inducers of CYP3A4 such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's wort may decrease plasma mifepristone levels; strong CYP3A4 inhibitor medications are expected to cause the largest increases in plasma mifepristone concentrations; mifepristone may increase the plasma drug concentration of concomitant medications with metabolism mediated by cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9)/cytochrome P450, family 2, subfamily C, polypeptide 8 (2C8)
Currently receiving treatment with agents that are metabolized solely through cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) and have a narrow therapeutic index or are strong cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors; or are receiving treatment with agents that carry a risk for QT prolongation and are CYP3A substrates; caution should be used in patients taking other CYP2C8- or CYP3A4/5-interacting agents
Potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors, such as ketoconazole and erythromycin, should be avoided during the study treatment period with trastuzumab emtansine
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
Current systemic treatment with a potent cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor such as ketoconazole or ritonavir
Drugs that are highly dependent on cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) for metabolism and have a narrow therapeutic index are allowed but must be used with caution
Medications with potent inducer or inhibitor of cytochrome P450 family 3, subfamily A, polypeptide 4 (P450 3A4) should be avoided within 5 half-lives of temsirolimus
Medications and/or diet are prohibited if they affect oral absorption of PF-00299804 or if primarily metabolized by cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6); patients must have been off treatment with these drugs for 2 weeks prior to enrollment; patients who otherwise are eligible can be enrolled only if drug substitution is performed with acceptable clinical outcome prior to enrollment
Patients with a seizure disorder may be enrolled if well controlled on anticonvulsants at a dose that has been stable for at least 14 days; however, drugs that induce cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5 (carbamazepine, oxcarbazepine, phenytoin, primidone, and phenobarbital) should be avoided
Drugs that potently inhibit cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) should either be prohibited or used with caution; drugs which are strong inducers of cytochrome P450 family 3, subfamily A (CYP3A) should also be prohibited; drugs that are substrates of CYP3A4 or cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) with a narrow therapeutic index may be prohibited; drugs that are sensitive substrates of CYP3A4 or CYP2C8 should be used with caution; it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians’ Desk Reference may also provide this information; 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
Drugs that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8), p-glycoprotein (Pgp) or ATP-binding cassette, sub-family G, member 2 (Bcrp) transporter; the list may be modified based on emerging data; consider therapeutic substitutions for these medications; patients must be off treatment for at least 1 week prior to enrollment
Ongoing treatment with sensitive cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment
The participant requires chronic concomitant treatment with the following strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers OTHER than antiretroviral agents: dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, primidone, modafinil, and other enzyme inducing anti-convulsant drugs (EIACD), and St. John’s Wort; use of efavirenz or etravirine is permitted for participants considered for the CYP3A4-inducer based antiretroviral therapy (ART) regimen arm (Stratum B) of the trial\r\n* Although study participants will be eligible regardless of smoking history, smokers should be strongly advised to stop smoking while on erlotinib; smoking induces cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) enzymes and alters erlotinib exposure by 64%
Concomitant use of drugs that strongly inhibit cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5)
Patients must discontinue any medication that causes strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) induction 2 weeks prior to treatment initiation; patients who are not able to discontinue these drugs are considered ineligible
Patients may not receive strong cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors, CYP2C8 inducers, or cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers; in addition, patients should not receive drugs that are metabolized by CYP3A4 or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9)
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with LDK378 and for the duration of participation:\r\n* Medication with a known risk of prolonging the QT interval or inducing torsades de pointes\r\n* Strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A poly peptide 4/5 (CYP3A4/5)\r\n* Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, and/or cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9)\r\n* Therapeutic doses of warfarin sodium (Coumadin) or any other coumarin-derived anti-coagulant; anti-coagulants not derived from warfarin are allowed (e.g., dabigatran, rivaroxaban, apixaban)\r\n* Unstable or increasing doses of corticosteroids\r\n* Enzyme-inducing anti-convulsive agents\r\n* Herbal supplements
Patients on any moderate or strong cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) inducer (e.g., carbamazepine, rifampin) or inhibitor (e.g., amiodarone, fluconazole) are ineligible; CYP2C9 poor metabolizers will not be excluded
Patients on narrow-therapeutic drugs that are substrates for cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2), CYP2C9, cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19), and cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, phenytoin, pimozide, quinidine, sirolimus, tacrolimus, theophylline, tizanidine, warfarin)
Use of potent cytochrome P450 family 3, subfamily A, polypeptide 4 (3A4) (CYP3A4) inhibitor within one week of pacritinib initiation
Need for medications that strongly induce or inhibit cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6) activity
Received potent cytochrome P450, family 3, subfamily A (CYP3A) inhibitors (e.g., ketoconazole) or inducers; or substrates of cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6) with narrow therapeutic indexes within 7 days prior to the first dose of study drug
It should be noted that TAK-700 (orteronel) is a weak inhibitor of cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2), cytochrome P450, family 2, subfamily C, polypeptide 9 (2C9), and cytochrome P450, family 2, subfamily C, polypeptide 19 (2C19); caution should be employed when used with medications that are strong/moderate inhibitors, significant inducers or sensitive substrates with narrow therapeutic indices
Use of rifampin (strong cytochrome P450 family 2, subfamily C, polypeptide 8 [CYP2C8] inducer) within 14 days of study day 1
Patients cannot be taking any cytochrome P450, cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) pathway inhibiting or inducing agents (except proton pump inhibitors which are allowed) including cimetidine, antidepressants, antibiotics and all others
Patients who are currently receiving drugs that are strong or moderate inhibitors and/or inducers of cytochrome P450 family 3 subfamily A polypeptide 4 (CYP3A4) or sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are not eligible; the use of aprepitant as an antiemetic is prohibited due to early drug interaction data demonstrating increased exposure to AZD1775; caution should be exercised with concomitant administration of AZD1775 and agents that are sensitive substrates of cytochrome P450 family 2 subfamily C polypeptide 8 (CYP2C8), family 2 subfamily C polypeptide 9 (2C9) and family 2 subfamily C polypeptide 19 (2C19), or substrates of this enzyme with narrow therapeutic ranges, as well as agents that are inhibitors or substrates of P-glycoprotein (P-gp)
Patients taking non-topical medication known to be a strong inhibitor of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); however patients who either discontinue their treatment or switch to another medication at least three days prior to randomization are eligible
Concomitant use of known cytochrome P450 (family 3, subfamily A, polypeptide 4, 5, 7 [3A4,5,7]) inducers such as carbamazepine, phenytoin, or oxcarbazepine
Use of select cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6) inhibitor medications
Subjects being treated concurrently with any prohibited medications, including investigational medication, rifampin, St. John’s wort, and potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (excluding ketoconazole) unless continuation of such medications are determined by the investigator to be in the best interest of the patient
Patients who are on strong inhibitors of cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8), strong or moderate inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CY3A4) and CYP2C8 should discontinue these medications 2 weeks prior to the start of treatment
Patients taking any potent inhibitor of cytochrome P450 family 3, subfamily A, polypeptide 4 (3A4) (e.g., ketoconozole, itraconozole, erythromycin, etc)
Taking medications known to affect drug metabolism via the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), CYP, family 2, subfamily C, polypeptide 9 (CYP2C9), or CYP, family 2, subfamily D, polypeptide 6 (CYP2D6) pathways
Participants are to discontinue the use of the following classes of inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); patients who are on these drugs are eligible if a washout period of a minimum of 7 days occurs before start of olaparib and temozolomide\r\n* Azole antifungals\r\n* Macrolide antibiotics\r\n* Protease inhibitors
Patients taking substrates, inhibitors, or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) should be encouraged to switch to alternative drugs whenever possible
Concurrent use or receipt of a strong CYP3A4 inducer within 12 days prior to randomization or a strong CYP3A4 inhibitor within 7 days prior to randomization (see Table 10)
Patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration
Concomitant use of medications known to have strong inhibition or induction of CYP3A enzymes is discouraged and should be discussed with the study principal investigator (PI); note that systemic corticosteroids (e.g., dexamethasone is a CYP3A inducer) are not allowed; inhaled corticosteroids are allowed
Use of potent inhibitor or inducer of CYP3A4/3A5 within 14 days of planned study treatment or expected requirement for use of such a drug during study
Use of a potent inhibitor or inducer of drug transporters or conjugating enzymes within 14 days prior to planned study treatment or expected requirement for use of such a drug during study
Is receiving concomitant treatment with a strong inhibitor or inducer of CYP3A4/5.
Require continued treatment with a medication that is known to be a strong inducer of CYP3A.
Use of a strong inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to the start of study therapy or expected requirement for use of a strong CYP3A4 inhibitor or inducer during study therapy.
Treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 inducer within the last 2 weeks
Intake of St. John's wort or hyperforin (potent cytochrome P450 [CYP] 3A4 enzyme inducer) or grapefruit juice (potent CYP3A4 enzyme inhibitor) within 7 days prior to initiation of study treatment
Concurrent use of any medications or substances (e.g. herbal supplement or food) known to be a strong inhibitor or strong inducer of CYP3A4.\r\n* Although corticosteroids are considered to be strong inducers of CYP3A4, physiologic replacement doses of corticosteroids =< 10 mg daily prednisone or equivalent are allowed.
The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:\r\n* St. John’s wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)\r\n* Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4.
The patient has taken a medication known to be a potent inducer of CYP1A2, CYP2C8, or CYP3A4 within 4 weeks prior to the first dose of study drug
Taken a strong inhibitor or inducer of CYP3A4 within 14 days prior to enrollment
The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment: (1) St. John’s wort or hyperforin (potent CYP3A4 enzyme inducer) (2) grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Subjects who are required to use a medication classified as a strong CYP3A inducer of inhibitor
Requires treatment with a strong CYP3A4 inhibitor/inducer
Patient who is on strong inducer/inhibitor of CYP3A needs to be off the medication prior to treatment initiation unless it is medically necessary for the patient
The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:\r\n* St. John’s wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)\r\n* Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Taking a strong inhibitor or inducer of cytochrome P450; intermediate inhibitors are allowed if deemed medically necessary
Has taken a medication that is a potent inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 1-week prior to screening.
Consumption of any concomitant nutritional, herbal supplements, and antioxidants should be taken under the discretion of the investigator; the following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:\r\n* St. John’s wort or hyperforin (potent CYP3A4 enzyme inducer)\r\n* Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Patient who are required to take a strong CYP3A4 inducer are excluded from the study
Has been treated with a cytochrome P450 3A4 (CYP3A4) strong inhibitor or inducer within 7 days of enrollment
A strong or moderate CYP3A inhibitor or inducer within 7 days
Is receiving concomitant treatment with a strong inhibitor or inducer of CYP3A4/5.
Concurrent use of a strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor or inducer; these medications should be discontinued or switched to a different medication with a weaker CYP3A4 interaction prior to enrollment into the study; if patients need to continue the same medication(s), they are excluded from the study
Received a potent CYP3A inhibitor within 7 days or potent CYP3A inducer within 5 weeks prior to first dose of AP32788.
Administration of a strong or moderate CYP3A inhibitor or inducer =< 14 days prior to registration
Treatment with any drug(s) known to be an inhibitor or inducer of cytochrome P450 (CYP)2C19, CYP3A4, CYP2C8, and CYP2E1, within 14 days of the date of first administration of study drug
Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
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
Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Treatment with a moderate or strong cytochrome P450 3A4 (CYP3A) inhibitor or inducer within 7 days prior to\r\nfirst dose of venetoclax or need for treatment with a strong CYP3A inhibitor or inducer during the period or the study; patients who have a need for treatment with a moderate CYP3A inhibitor or inducer during venetoclax dose escalation will also be excluded
Concurrent use of any medications or substances (e.g. herbal supplement or food) known to be a strong inhibitor or strong inducer of CYP3A4
Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the initiation of study treatment.
Requires treatment with a strong CYP3A inhibitor/inducer.
Receipt of a strong CYP3A4 inducer within 12 days prior to cycle 1 day 1 or a strong CYP3A4 inhibitor within 7 days prior to cycle 1 day 1 (Table 8)
Intake of St. John's wort or hyperforin (potent cytochrome P450 [CYP] 3A4 enzyme inducer) or grapefruit juice (potent CYP3A4 enzyme inhibitor) within 7 days preceding the start of study treatment to the end of treatment
Use of strong CYP3A4 inducer
Patients must not have continued requirement for therapy with a strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitor or inducer
Use of a strong CYP3A4 inducer or inhibitor, or strong CYP2C8 inducer or inhibitor within 3 elimination half-lives of the inhibitor or inducer prior to first dose of study treatment
Patients requiring treatment with a strong CYP3A4 inhibitor or inducer Additional exclusion criteria for PDR001/Panobinostat-
Patients requiring a strong inhibitor or inducer of CYP3A4
Use of potent cytochrome P450 3A4 (CYP3A4) inducer within one week of pacritinib initiation
Requires ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome 3A4 (CYP3A4) enzymes
Use of a strong CYP2C8 inducer or inhibitor within three elimination half-lives of the inducer or inhibitor prior to the start of study treatment.
Current or anticipated use of a P glycoprotein (P gp) inhibitor (eg, dronedarone, quinidine, ranolazine, itraconazole, ketoconazole), strong P gp inducer (eg, rifampin, ritonavir, tipranavir), or strong inhibitor of breast cancer resistance protein (BCRP) (eg, elacridar [GF120918]).
Use of prohibited medications (strong CYP3A4 or CYP2C8 inducers or inhibitors, or moderate CYP2C8 inhibitor trimethoprim) within 3 elimination half-lives of the inducer or inhibitor prior to first dose of the study treatment
The following foods/supplements are prohibited at least 7 days prior to initiation of\r\nand during study treatment:\r\n* St. John’s wort or hyperforin (potent cytochrome P450 family 3, subfamily A, polypeptide 4 [CYP3A4] enzyme inducer)\r\n* Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Use of any strong CYP3A4 inducer such as rifampin, St John's Wort, or other herbal preparations that contain any strong CYP3A4 inducer (see Table 6 6) 14 days before the first dose of study drug or during the study
Concurrent administration of crizotinib and a strong inhibitor or inducer of cytochrome P450, family 3, subfamily A (CYP3A) is not permitted; many over-the-counter and dietary supplements also inhibit or induce CYP3A and thus are prohibited
St. John's wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)
Use of strong cytochrome P450 3A4 (CYP3A4) inducer within 2 weeks prior to the first dose of MMB
Concurrent therapy with a potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer or inhibitor; subjects may enter screening when therapy with the potent inhibitor or inducer is completed and may begin study treatment after 1 week or 5 half-lives, whichever is longer
Administration or possibility of initiating or continuing any treatment with any known Cytochrome P450 3A4 (CYP3A4) and CYP2C19 enzyme and P-glycoprotein altering drugs (inducer or inhibitor) or non drug agents within 14 days prior to dosing and during the primary objective phase
Patient has received any of the following agents within 3 days prior to study day 1 and/or are planned to receive throughout the duration of the study: opioid antagonist and mixed agonist/antagonist (e.g. pentazocine, buprenorphine, nalbuphine, naloxone/naloxone combinations, naltrexone/naltrexone combinations, methylnaltrexone, alvimopan), a strong cytochrome P450 family 3 subfamily A polypeptide 4 (CYP3A4) and/or P-glycoprotein 1 (P-gp) inhibitor, a moderate CYP3A4 and/or P-gp inhibitor, and/or a strong CYP3A4 inducer
Currently using select CYP2D6 inhibitor or inducer medications
Current use of strong CYP3A4 inducers or inhibitors\r\n* NOTE: patients may be eligible if they transition to an alternative agent or are able to stop CYP3A4 inducer or inhibitor
Subjects on a potent CYP3A4 inhibitor or CPY3A4 inducer who cannot be changed to another medication are excluded
Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the cytochrome P450 (CYP)3A or CYP2C9 pathways (patients should discontinue taking any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A or CYP2C9 pathways)
Participants taking any drug that is a strong inhibitor or inducer of the CYP3A4 enzyme within at least 2 weeks before the start of study drug and during the conduct of the study unless there is an emergent or life-threatening medical condition that requires it
Subjects currently being treated with a CYP 2C9, CYP 2C8, CYP 2C19, CYP 2D6, and P-gp substrate with a narrow therapeutic index.
Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
Patients who requires treatment with a strong cytochrome P450 (CYP) family 3, subfamily A (3A) inhibitor
For cohort 2 (MCL) only: strong CYP3A4 inducers/inhibitors within 14 days prior to day 1 of protocol therapy and/or requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
Use of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4.
Requires treatment with a strong cytochrome P(CYP)450 3A inhibitor OR subjects who have received a strong cytochrome P(CYP)450 3A inhibitor within 7 days prior to the first dose of ibrutinib or subjects who require continuous treatment with a strong CYP 450 3A inhibitor
Use of a moderate or strong inhibitor or inducer of cytochrome P450 (CYP) 3A4 within 7 days prior to the expected start of ibrutinib therapy.
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
Current use of a strong cytochrome P450 (CYP) 3A4/5 inhibitor or inducer
Requires treatment with a strong cytochrome (CYP) 3A4/5 inhibitor
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitors or inducer
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor/inducers
Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
Requires treatment with a strong cytochrome P450 (CYP), family 3, subfamily A (3A) inhibitor
Requires treatment with a strong cytochrome P450 (CYP) family 3, subfamily A (3A) inhibitor
Requirement to receive treatment with a strong cytochrome P450 (CYP) 3A inhibitor
Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
Current treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor or inducer (EIAEDs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed)
Subjects who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or subjects who require continuous treatment with a strong CYP 450 3A inhibitor
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
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
Strong inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited; grapefruit juice is an inhibitor of CYP450 and should not be taken with pazopanib
Patients who require treatment with a strong cytochrome P450 (CYP) 3A inhibitor
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
Patients who require treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Requires treatment with a strong cytochrome P450 (CYP) family 3, subfamily A, polypeptide 4/5 (3A4/5) inhibitor
Requirement for treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor
Concurrent use of a strong cytochrome P450(CYP) 3A inhibitor.
Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) family 3, subfamily A (3A) inhibitor
Any previous exposure to a CYP17 (17?-hydroxylase/C17,20-lyase) inhibitor;
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
Patients who requires treatment with a potent cytochrome P450 (CYP) 3A inhibitor or inducer
Concurrent use of known cytochrome P450 3A4 (CYP 3A4) inhibiting or activating medications
Concurrent use of a strong cytochrome P450 (CYP)3A4/5 inhibitor
Requires chronic treatment with strong cytochrome P450 (CYP)3A inhibitors
Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor
Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug.
Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug.
Treatment with a strong cytochrome P450 (CYP) 3A inhibitor
Patients should agree to avoid grapefruit juice which is a major inhibitor of cytochrome P-450 (CYP)3A4
Requires treatment with a strong cytochrome P450 (CYP) family 3, subfamily A, polypeptide 4/5 (3A4/5) inhibitor
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
Has received concomitant treatment with a strong inhibitor or inducer of cytochrome P450 (CYP)3A4/5 within 7 days of first receipt of DS-3201b
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
Requires treatment with a strong CYP 3A inhibitor
Patients who are currently receiving drugs that are strong or moderate inhibitors and/or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are not eligible; the use of aprepitant as an antiemetic is prohibited; caution should be exercised with concomitant administration of AZD1755 (MK-1775) and agents that are sensitive substrates of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8), 2C9 and 2C19, or substrates of this enzyme with narrow therapeutic ranges, as well as agents that are inhibitors or substrates of permeability glycoprotein (P-gp)
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
Patients must be able to discontinue CYP2C9 substrates with a narrow therapeutic index (e.g. warfarin, phenytoin), if randomized to TGR-1202; patients must discontinue such agents at least 1 week or 5 half-lives prior to beginning protocol therapy (whichever is longer)
Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates with narrow therapeutic indices: Patients chronically receiving medications known to be metabolized by 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
Sensitive or narrow therapeutic range substrates of CYP2D6
Exposure to sensitive or narrow therapeutic range substrates of the drug metabolising enzymes CYP2C8, CYP2C9, CYP2C19 or the drug transporters Pgp, BCRP, OATP1B1, OATP1B3, OCT1 and OCT2 within the appropriate wash-out period before the first dose of study treatment.
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.
An oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of dosing in the study
Require continued treatment with a medication that is a sensitive CYP2C9 substrate with a narrow therapeutic index.
Medications that have a narrow therapeutic window and are predominantly metabolized through CYP2C8, CYP2C9, CYP2C19, or CYP3A4;
known P gp substrates with a narrow therapeutic index
Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib.
Participants receiving any medications, substances, or foods (i.e., grapefruit juice) listed below are ineligible:\r\n* Prescription or non-prescription drugs or other products known to be sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued prior to study start and withheld throughout the study until 2 weeks after the last dose of study drug; sensitive substrates of CYP2C8, CYP2C9, CYP2C19, or substrates of these enzymes with narrow therapeutic range\r\n* Inhibitors or substrates of P-glycoprotein (P-gp)
Patients who are currently receiving drugs that are strong or moderate inhibitors and/or inducers of CYP3A4, sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are not eligible; the use of aprepitant or fosaprepitant as an antiemetic is prohibited due to early drug interaction data demonstrating increased exposure to AZD1775; the use of hydroxymethylglutary (HMG) coenzyme-A (Co-A) inhibitors such as atorvastatin is prohibited
Patient has had prescription or non-prescription drugs or other products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug; co-administration of aprepitant or fosaprepitant during this study is prohibited; the use of sensitive substrates of CYP3A4, such as atorvastatin, simvastatin and lovastatin, is also prohibited in this study; transporter studies (in vitro) have shown that AZD1775 is an inhibitor of breast cancer resistance protein (BCRP); 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
Any chronic therapy or use of food supplements that are strong CYP3A4/5 inducers or inhibitors or sensitive substrates of CYP3A or CYP2D6 with a narrow therapeutic window Abiraterone-Specific Exclusion Criteria:
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
Rx or non-Rx drugs or other products known to be sensitive BCRP or OAT1 substrates or to be potent inhibitors/inducers of CYP1A2, which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of AZD4635.
Treatment with any medication which is predominantly metabolized by CYP3A4 and has a narrow therapeutic index.
Is chronically taking a sensitive CYP3A substrate or a CYP3A substrate with a narrow therapeutic index and cannot be switched to an alternative agent at least 7 days prior to study initiation that in the opinion of investigator/treating physicians precludes utilization of idelalisib
Drugs which are substrates for the drug transporter multidrug resistance protein 1 (MDR1) have a narrow therapeutic window; or which are strong inhibitors of drug transporter MDR1.
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)
Concurrent therapy with strong inhibitors or inducers of CYP3A4 or CYP2C8 or with sensitive substrates of CYP3A4, CYP2C9 or CYP2C19
Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate
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
Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate.
Treatment with any medication which is predominantly metabolized by CYP3A4 and has a narrow therapeutic index.
Trametinib may be an inhibitor of CYP2C8 in vivo; caution should be exercised when dosing trametinib concurrently with medications with narrow therapeutic windows that are substrates of CYP2C8
An oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of dosing in the study
Treatment with any medication which is predominantly metabolized by CYP3A4 and has a narrow therapeutic index
Concurrent administration of strong inducers and inhibitors of CYP3A enzyme or CYP3A substrates with narrow therapeutic window
Co-administration of CYP3A4 ligands that serve as substrates or induce or inhibit the enzyme.
Concomitant use of strong CYP3A4, CYP1A2, or CYP2C9 substrates
Subject has had prescription or non-prescription drugs or other products known to be sensitive cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued two weeks prior (alternatively 5 half lives if T1/2 is known) prior to day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug\r\n* NOTE: co-administration of aprepitant or fosaprepitant during this study is prohibited\r\n* Note: individual drugs exerting CYP interactions may be continued on a case by case basis if felt essential for patient management, after discussions and discretion of the treating physician\r\n* The preferred azole anti-fungal medication is fluconazole (alternatively posaconazole) which can be given during treatment with AZD1775 at the treating physician’s discretion, however with dose reductions of AZD1775 by 25-75% (i.e. from AZD1775 200mg to 150 or 100mg)
known to be substrates of CYP3A4/5 and P-gp with a narrow therapeutic index
Unable or unwilling to discontinue use of any sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic window
Patient has had prescription or non-prescription drugs or other products (i.e., grapefruit juice) known to be sensitive to cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors or inducers of CYP3A4, which cannot be discontinued 2 weeks before day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug
Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index; if an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate
All CYP2C8 inhibitors, inducers, and substrates should be discontinued >= 7 days prior to registration; systemic treatment with CYP2C8 inhibitors (anastrozole, montelukast, quercetin, trimethoprim, gemfibrozil, rosiglitazone, pioglitazone), inducers (carbamazepine, phenytoin, rifabutin, rifampin), or substrates (amiodarone, repaglinide, rosiglitazone, sorafenib, torsemide) should be discontinued >= 7 days prior to registration
Patient has had prescription or non-prescription drugs or other products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks prior to day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug; co-administration of aprepitant or fosaprepitant during this study is prohibited; the use of sensitive substrates of CYP3A4, such as atorvastatin, simvastatin and lovastatin, is also prohibited in this study
Patient has had a prescription or non-prescription drugs or other products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks prior to day -3 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug. Co-administration of aprepitant or fosaprepitant during this study is prohibited.
Current use of strong CYP3A inhibitors such as ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, and clarithromycin are prohibited; NOTE: moderate inhibitors of CYP3A4 should be used with caution; navitoclax is a moderate inhibitor of CYP2C8 and a strong inhibitor of CYP2C9; caution should be exercised when dosing navitoclax concurrently with CYP2C8 and CYP2C9 substrates; common CYP2C8 substrates include paclitaxel, statins and repaglinide; CYP2C9 substrates include celecoxib, phenytoin and warfarin; when possible, investigators should switch to alternative medications or monitor the patients closely
Drugs known to be CYP3A4 substrates with narrow therapeutic windows (such as alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, sirolimus, or terfanide) or CYP2C8 substrates are not allowed; patients must be switched to alternative drugs at least 14 days prior to receiving the first dose of AMG 232; those patients who cannot switch to alternative drugs will be excluded from the study
Strong CYP2C8 inhibitors or CYP2C8 substrates
OATP1B1/3 substrates Received the following within 14 days prior to the initiation of study treatment: * Strong CYP2C8 inducers
Strong CYP2C8 inhibitors or CYP2C8 substrates
OATP1B1/3 substrates
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
Drugs that potently inhibit cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) should be prohibited or used with caution; drugs which are strong inducers of CYP3A and may result in lower exposures of GSK2141795 should also be prohibited; drugs that are substrates of CYP3A4 or cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) with a narrow therapeutic index may be prohibited; drugs that are sensitive substrates of CYP3A4 or CYP2C8 should be used with caution\r\n* Caution should be exercised when dosing trametinib concurrently with medications with narrow therapeutic windows that are substrates of CYP2C8; drugs that potently inhibit or induce CYP3A4 should be administered with caution\r\n* Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians’ Desk Reference may also provide this information; 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\r\n* The following medications (including but not limited to) are prohibited during the study:\r\n** PROHIBITED-highly sensitive and/or low therapeutic index\r\n*** Cisapride\r\n*** Pimozide\r\n*** Astemizole\r\n*** Rosuvastatin, sulfasalazine\r\n** PROHIBITED-strong inducers/inhibitors of CYP3A4\r\n*** Clarithromycin, telithromycin, rifamycin class agents (e.g., rifampin, rifabutin, rifapentine), troleandomycin\r\n*** Itraconazole, ketoconazole\r\n*** Nefazodone\r\n*** Atazanavir, delavirdine, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, nevirapine\r\n*** Carbamazepine, phenobarbital, phenytoin\r\n* The following medications (including but not limited to) that may alter the concentrations of trametinib or GSK2141795 or have their elimination altered by trametinib or GSK2141795 should be administered WITH CAUTION:\r\n** USE WITH CAUTION-Drugs potentially affecting trametinib or GSK2141795 concentrations\r\n*** Quinidine, diltiazem, verapamil\r\n*** Fluvoxamine, fluoxetine, paroxetine, nefazodone\r\n*** Aprepitant, cimetidine\r\n*** Fluconazole, terbinafine, voriconazole\r\n*** Ciprofloxacin, erythromycin, isoniazid\r\n*** Mibefradil, diltiazem, verapamil\r\n*** Aprepitant, oxandrolone, tizanidine, gemfibrozil\r\n** USE WITH CAUTION-Drugs that may inhibit permeability (P)-glycoprotein (gp) and breast cancer resistance protein (BCRP)\r\n*** Valspodar\r\n*** Atorvastatin\r\n*** Carvedilol\r\n*** Methadone\t\r\n*** Meperidine\t\r\n*** Omeprazole\r\n** USE WITH CAUTION-Drugs that may have their concentrations altered by trametinib or GSK2141795\r\n*** Repaglinide, rosiglitazone, pioglitazone\r\n*** Alfentanil, fentanyl\t\r\n*** Quinidine \r\n*** Cilostazol\r\n*** Astemizole\r\n*** Diergotamine, ergotamine, eletriptan\r\n*** Pimozide\r\n*** Buspirone\r\n*** Felodipine\r\n*** Sildenafil, tadalafil, vardenafil\r\n*** Cerivastatin, lovastatin, simvastatin, atorvastatin\r\n*** Alprazolam, diazepam, midazolam, triazolam\r\n*** Cyclosporine, sirolimus, tacrolimus\r\n*** Cisapride\r\n*** Cyclosporine, torsemide, chloroquine, zopiclone\r\n*** Eplerenone\t\r\n*** Chloroquine, zopiclone\r\n** Use of repaglinide, rosiglitazone and/or pioglitazone is permitted only after consultation with the Cancer Therapy Evaluation Program (CTEP) Medical Monitor
Current use or anticipated need for food or drugs that are known strong or moderate CYP3A4 inhibitors, inducers and substrates; drugs that are CYP2C9 substrates; drugs that are sensitive CYP2B6 substrates; drugs that are strong CYP2C19 inhibitors; drugs that are strong CYP2C8 inhibitors; and drugs that are P-gp substrates.
Concomitant use of agents with narrow therapeutic windows that are metabolized by CYP3A4, cytochrome P450 2D6 (CYP2D6), or cytochrome P450 2C8 (CYP2C8) is not recommended
Patients taking the following prescription or non-prescription drugs or other products (i.e. grapefruit juice) are ineligible: sensitive cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) substrates, CYP3A4 substrates with a narrow therapeutic index, moderate to potent inhibitors/inducers of CYP3A4; patients would be eligible if the medications can be discontinued two weeks prior to day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication
Participants taking medications that are known potent CYP3A4 inducers/inhibitors or substrates with narrow therapeutic indices or St. John's Wort.
Sensitive CYP3A4/5 substrates or CYP3A4/5 substrates with narrow therapeutic index (NTI)
Sensitive CYP2D6 substrates or CYP2D6 substrates with NTI
Selected dual substrates of CYP3A4/5 and CYP2C8
Selected dual substrates of CYP3A4/5 and CYP2D6
Selected dual substrates of OATP and CYP450
Selected dual substrates of CYP3A4/5 and P-gp
NTI P-gp substrates
Prescription or non-prescription drugs or other products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued two weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug.
Use of any medications that induce, inhibit, or are substrates of CYP450 3A4
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 metabolized through CYP3A4/5 and have a narrow therapeutic index or medications that are CYP3A4 substrates that cause QT prolongation
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
Patients requiring medications with narrow therapeutic index CYP3A4 substrates
Patients who require the following treatments moderate to strong CYP3A4 inhibitors; any substrates of CYP3A4/5 with a narrow therapeutic index
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
Exposure to sensitive or narrow therapeutic range substrates of the drug metabolizing enzymes CYP2C8, CYP2C9, CYP2C19, CYP2D6 or the drug transporters Pgp (MDR1), BCRP, OATP1B1, OATP1B3, OCT1 and OCT2 within the appropriate wash-out period (a minimum of 5 x reported elimination half-life) before the first dose of study treatment
Medi4736+AZD5069 Cohort only: received any potent and moderate cytochrome CYP3A4 inhibitors, potent and moderate CYP3A4 inducers, P-gp substrates, BCRP substrates, sensitive CYP2B6 substrates, warfarin and coumarin derivatives, or herbal supplements within 14 days of the first dose of study treatment
Patients who are currently receiving treatment (that cannot be discontinued at least 1 week prior to the initiation of the study) with agents that are known to be any of the following: strong inducers or inhibitors of CYP3A4/5; sensitive substrates of CYP3A; substrates of CYP3A4/5 or CYP2C9 with a narrow therapeutic index.
Receiving medications that are moderate or strong inhibitors or inducers of CYP3A4 or that are sensitive substrate or substrates with a narrow therapeutic index of CYP3A4, CYP2D6, or CYP2C9 (see Appendix D)
Use of cytochrome P450 isoenzyme 3A4 (CYP3A4)/ CYP2C19 substrates
Substrates of CYP2D6 with a narrow therapeutic index (eg, thioridazine);
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).
CYP3A4 substrates with narrow therapeutic index
Certain medications that act through the cytochrome P450 (CYP450) system are specifically prohibited in subjects receiving pazopanib and others should be avoided or administered with extreme caution and require principal investigator (PI) approval\r\n* Strong inhibitors of CYP3A4 such as ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole may increase pazopanib concentrations and are prohibited; grapefruit juice is also an inhibitor of CYP450 and should not be taken with pazopanib\r\n* Strong inducers of CYP3A4, such as rifampin, may decrease pazopanib concentrations, are prohibited\r\n* Medications which have narrow therapeutic windows and are substrates of CYP3A4, CYP2D6, or CYP2C8 should be avoided and, if necessary, administered with caution\r\n* Pazopanib, 800 mg once daily, has no effect on CYP2C9, CYP1A2, or CYP2C19 in vivo but does in vitro; therefore, therapeutic doses of warfarin, a substrate of CYP2C9, and omeprazole, a substrate of CYP2C19 are permitted; caffeine, a substrate of CYP1A2, is also permitted
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)
Concomitant treatment with strong inhibitors or inducers of CYP1A2, CYP3A4 or CYP3A5 or sensitive substrates with narrow therapeutic index (TI) of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there was an emergent or life-threatening medical condition that required it.
CYP3A4 or CYP2C19 or P glycoprotein (P-gp) or breast cancer resistance protein (BCRP) substrates having a narrow therapeutic index;
Patients taking the following prescription or non-prescription drugs or other products (i.e. grapefruit juice) are ineligible: sensitive cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates, CYP3A4 substrates with a narrow therapeutic index, moderate to potent inhibitors/inducers of CYP3A4; patients would be eligible if the medications can be discontinued two weeks prior to day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication
Substrates of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19)\r\n* Preliminary results of a clinical drug-drug interaction study, examining the effect of ganetespib on the pharmacokinetics of the CYP2C19-sensitive probe omeprazole, show a modest (20%) increase in omeprazole exposure when coadministered with ganetespib; in vitro data implies expectation of greater interaction with CYP2C19 substrates than with CYP3A4 substrates; caution is advised when sensitive narrow therapeutic range CYP3A4 or CYP2C19 substrates are concomitantly administered
Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment
Subject has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be sensitive CYP3A4 substrates
Receiving treatment with medications that are known CYP3A, CYP1A2, CYP2C8, CYP2C9 or CYP2C19 substrates with narrow therapeutic index, and cannot be discontinued during the course of the study.
Known poor metabolizers of CYP2C9 substrates
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)
Narrow therapeutic index substrates of CYP2C8, CYP2C9, CYP2C19 and CYP2D6
Sensitive substrates for cytochrome P450 2C8 or 3A4 (e.g., repaglinide, midazolam, sildenafil);
Patients may not be on drugs known to be moderate or potent inhibitors/inducers of CYP3A4, sensitive substrates of CYP3A4, or substrates of CYP3A4 with narrow therapeutic windows
Participants who must receive CYP2C8 inhibitors, substrates and inducers, strong CYP3A4 inducers, or OATP1B1/3 substrates while on study. These must be discontinued 7 days (inhibitors and substrates) or 14 days (inducers) prior to start of study medication
Use with caution:\r\n* CYP2C19 non-sensitive substrates with a narrow therapeutic window and weak inhibitors are permitted if no acceptable alternatives are available as determined by the treating physician; however, caution should be used; consider monitoring with labs or drug levels and dose adjustments of the medication if feasible; other non-sensitive substrates are allowed on study\r\n* CYP3A4/5 sensitive substrates and any non-sensitive substrates with a narrow therapeutic window and weak inhibitors are permitted if no acceptable alternatives are available as determined by the treating physician; however, caution should be used; consider monitoring with labs or drug levels and dose adjustments of the medication if feasible; other non-sensitive substrates are allowed on study\r\n* CYP2D6 inducers, moderate/strong inhibitors or sensitive substrates are permitted if no acceptable alternatives are available; however, caution should be used; other non-sensitive substrates or weak inhibitors of CYP2D6 are allowed on study
Permeability-glycoprotein (P-gp) substrates with a narrow therapeutic index
Patients who are currently receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with WNT974:\r\n* Strong inhibitors or inducers of cytochrome P450, subfamily IIIA, polypeptide 4/5 (CYP3A4/5)\r\n* CYP3A4/5 substrates with narrow therapeutic index\r\n* Known to prolong the QT interval and are also CYP3A4/5 substrates
Use of drugs metabolized by CYP2D6; these are called CYP2D6 substrates
On scheduled CYP3A4 substrates with narrow safety range at the time of study enrollment (alfentanil, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus)
Currently receiving medications known to be strong inhibitors of CYP2C8, strong inducers (except enzalutamide) or inhibitors of CYP3A4 and substrates of CYP3A4, CYP2C9 and CYP2C19 with a narrow therapeutic window. Strong inducers, inhibitors and substrates must be discontinued at least 7 days prior to the first administration of study drug.
Inability to discontinue drugs that are strong cytochrome P450 3A4 (CYP3A4) or P450 3A5 (CYP3A5), cytochrome P450 2C19 (CYP2C19), and cytochrome P450 2C9 (CYP 2C9) inhibitors and/or inducers; and substrates of CYP 3A4/5 or CYP1A2 that are sensitive or have a narrow therapeutic window at least three weeks prior to study registration
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.
Need to use drugs that have a narrow therapeutic index and are substrates for CYP2B6, CYP2C8, CYP2C9, CYP2C19, OATP1B1, OATP1B3, and OCT1 (organic cation transporter 1), ie warfarin, digoxin, phenytoin, paclitaxel, S-mephenytoin
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
Caution should be exercised when inhibitors or substrates of P-glycoprotein (P-gP), substrates of cytochrome P450 family 1 subfamily A member 2 (CYP1A2) with a narrow therapeutic range, sensitive substrates of cytochrome P450 family 2 subfamily C member 19 (CYP2C19) or CYP2C19 substrates with a narrow therapeutic range are administered with AZD1775
Subject has had prescription or non-prescription drugs or other products known to be sensitive cytochrome P450 family 3 subfamily A member 4 (CYP3A4) substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors / inducers of CYP3A4 which cannot be discontinued two weeks prior to day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug; co-administration of aprepitant or fosaprepitant during this study is prohibited
Patients who are taking medications that may alter the metabolism of zolpidem; this includes strong CYP3A4 inhibitors or inducers or CYP3A4 substrates with a narrow therapeutic index
Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited to dihydroergotamine, ergotamine, and pimozide.
Patients who are taking medications that may alter the metabolism of enzalutamide; this includes the following: strong or moderate CYP2C8 inhibitors or inducers; strong CYP3A4 inhibitors or inducers; or CYP2C9, 2C19 or 3A4 substrates with a narrow therapeutic index
CYP3A substrates with narrow therapeutic window (including, but not limited to, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus).
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4/5 are ineligible; the required washout period prior to starting treatment is 2 weeks for CYP3A inhibitors, 3 weeks for CYP3A inducers, and 5 weeks for enzalutamide; dihydropyridine calcium-channel blockers are permitted for management of hypertension
The following medications or non-drug therapies are also prohibited while on treatment in this study:\r\n* Other anti-cancer therapies\r\n* Other investigational drugs\r\n* Patients taking any medications or substances that are strong inhibitors or inducers of CYP3A or CYP2C8 are ineligible
Patients receiving any medications or substances that are potent inhibitors or inducers of
Patients receiving any medications or substances that are strong inhibitors of CYP450 3A4 isoenzyme are ineligible; patients must be off the strong inhibitor for at least 1 week prior to being deemed eligible
Receiving any medications or substances that are inducers of CYP3A4; use of inducers are prohibited =< 7 days prior to randomization
Participants receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A isoenzymes are ineligible; lists including medications and substances known or with the potential to interact with the CYP3A isoenzymes
Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible
Receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days prior to registration
Receiving any medications or substances which in the opinion of the investigators would interfere with treatment; examples could include strong inhibitors of CYP3A4 at oncologist discretion
Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 complex. Lists including medications and substances known or with the potential to interact with the CYP3A4 isoenzymes
Patients receiving any medications or substances that are strong inhibitors and/or strong or moderate inducers of CYP3A4 are ineligible
Patients receiving any medications or substances that are moderate to strong inhibitors CYP1A2 are ineligible
Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible
Patients receiving any medications or substances that are potent inhibitors or inducers of CYP1A2 or CYP2D6 are ineligible
Patients receiving any medications or substances that are strong inhibitors or inducers of CYP1A2 and/or CYP3A4 are ineligible
PHASE I AND II SCLC AND UROTHELIAL CARCINOMA EXPANSION COHORT: Patients receiving any medications or substances that are strong and moderate inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) are ineligible
mCRPC EXPANSION COHORT: Patients receiving any medications or substances that are strong and moderate inhibitors or inducers of CYP3A are ineligible
Subjects requiring any medications or substances that are strong inhibitors or inducers of CYP3A during the course of the study are ineligible
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
Receiving any medications or substances that are inducers of CYP3A4; use of inducers are prohibited =< 7 days prior to registration
Participants receiving any medications or substances that are potent inhibitors of CYP3A4, including grapefruit juice are ineligible; participants receiving fluconazole are also ineligible
Patients receiving any medications or substances that are substrates, inducers, or inhibitors of cytochrome P450 2C9 (CYP2C9) enzyme
TREATMENT: Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics (i.e., cytochrome P450, family 3, subfamily A, polypeptide 4 [CYP450], P-glycoprotein [PgP]) of any of the study drugs will be determined following review of their cases by the principal investigator (PI); patients on strong and moderate cytochrome P450 system inducers or inhibitors are ineligible; every effort would be made to switch patients off medications that are known substrates of CYP450; if it is medically important for the patient to remain on such medications, these patients can still be eligible to participate based on PI discretion
DOSE ESCALATION COHORT: Current use or anticipated need for treatment with any medications or substances that are inhibitors or inducers of CYP3A4
DOSE EXPANSION COHORT: Current use or anticipated need for treatment with any medications or substances that are inhibitors or inducers of CYP3A4
Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A4 are ineligible; the required washout period for strong inhibitors is 2 weeks and at least one week for moderate inhibitors; the required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 4 weeks for other agents
Patients who need chronic use of medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible\r\n* Strong inhibitors and inducers of UGT/PgP should be used with caution
Patients receiving any medications or substances to treat active infection
Concurrent use of medications or substances that are strong inhibitors of CY3A4 are ineligible
Receiving any medications or substances that are inducers of cytochrome CYP450 2C8; use of the following inducers is prohibited =< 7 days prior to registration\r\n* Inducer of CYP2C8: rifampin
Receiving any medications or substances that are inducers of CYP450 2C9; use of the following inducers is prohibited =< 7 days prior to registration\r\n* Inducers of CYP2C9: rifampin, secobarbital
PHASE II: Patients must NOT be taking current medications or substances that are inhibitors or inducers of CYP3A4
Patients who require prohibited medications with potential for serious interactions with protocol therapy, and who cannot have therapeutic substitution are excluded; patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 (CYP450) enzyme(s) are ineligible
Because MK-2206 is metabolized primarily by the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) liver enzyme, 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
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) isoenzymes are ineligible
Use of any medication or substances that are strong inhibitors or inducers of CYP3A isoenzymes.
Receiving any medications or substances that are inducers of CYP3A4; use of inducers are prohibited =< 7 days prior to registration
Patients receiving certain medications and/or substances that are prohibited within stated wash-out periods
The eligibility of patients taking medications that are potent inducers or inhibitors of the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) liver 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; any identified agent needs to be stopped at least 2 weeks prior to study registration
Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP 450 3A4) are ineligible
Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4
Patients receiving any medications or substances that are inhibitors or inducers of CYP450 enzyme(s) are ineligible
PHASE II: Participants receiving any medications or substances that are strong inhibitors of CYP3A4 are ineligible
Receiving any medications or substances that are inducers of CYP3A4\r\n* Use of inducers is prohibited =< 12 days prior to registration
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) complex are ineligible
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; an exception will be made for patients who are on ritonavir-based highly active antiretroviral therapy, in which case the starting dose of sunitinib will be modified; every effort should be made to switch patients taking such agents or substances to other medications
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are ineligible
Prohibited medications, supplements and herbal medications:\r\n* Tetracycline and its derivatives (enhance the risk of retinoic acid toxicity)\r\n* Live vaccines\r\n* Vitamin A\r\n* St. John’s wort\r\n* Dong quai: Herbal supplement, (Angelica sinensis)\r\n* Cytochrome P450 family 2 subfamily C member (CYP2C8) inhibitors: gemfibrozil, trimethoprim, thiazolinediones, montelukast, quercetin\r\n* CYP2C8 inducers: rifampicin\r\n* Patients receiving any medications or substances that are moderate and strong inhibitors of CYP2C8 or inducers of CYP2C8 are ineligible and can only be enrolled if these medications are discontinued
Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP450 3A4) are ineligible
Patients who require concurrent treatment with any medications or substances that have significant proarrhythmic potential are ineligible
Strong CYP3A4 inhibitors are not permitted within 7 days before and during the study, and strong CYP3A4 inducers are not permitted within 12 days before and during the study; every effort should be made to switch patients taking such agents or substances to other medications 1 week prior to starting therapy, particularly patients with brain metastases who are taking enzyme-inducing anticonvulsant agents; patients who require potent CYP3A4 inducers or inhibitors and cannot switch medications must have their case reviewed by the coordinating center PI and may be enrolled only after discussion with and agreement from the coordinating center PI; eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics (PK) of cediranib will be determined following review of their case by the coordinating center PI
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
Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 (CYP450) enzyme(s) are ineligible
Receiving any medications or substances that are inducers of CYP3A4
Participants receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible
Refusal or inability to discontinue medications or other substances (eg, foods or dietary supplements) that may affect 18F SKI-249380 metabolism; notably, as dasatinib metabolism is cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)-dependent, the metabolism of 18F SKI-249380 may be altered by inhibitors and inducers of cytochrome P450 isoenzyme CYP3A4; the acceptability of medications and other substances used by the patient will be determined by the study investigators
Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 and UGT are ineligible; the wash out period for such drugs is a minimum of 7 days or 5 half-lives whichever is shorter\r\n* Note: If a medication is incorrectly documented as prohibited in this protocol, documentation from the site pharmacist to the contrary will be acceptable for the purposes of registration
Concomitant treatment with strong inhibitor of P-glycoprotein (P-gp)
Require continued treatment with a medication that is known to be a strong inhibitor of CYP2C8.
Treatment with gemfibrozil (strong CYP2C8 inhibitor) within 14 days before the first dose of TAK-580
Requires treatment with a strong cytochrome P450 CYP3A4/5 inhibitor
Unable to discontinue use of a strong CYP3A4 inhibitor
Subjects who require therapy with a strong CYP3A4 inhibitor prior to enrollment to this study
The use of strong CYP3A4 inhibitor (with the exception of ketoconazole).
Requires treatment with a strong CYP3A4/5 and/or CYP2D6 inhibitor
Received a strong cytochrome P450 (CYP) 3A inhibitor or inducer within 7 days prior to the first dose of ibrutinib, OR subjects who require continuous treatment with a strong cytochrome P450 CYP3A inhibitor or inducer
Subjects who received a strong cytochrome P 450 3A (CYP3A) inhibitor within 7 days prior to the first dose of ibrutinib or subjects who require continuous treatment with a strong CYP3A inhibitor
Subjects who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or subjects who require continuous treatment with a strong CYP3A inhibitor
Subjects who received a strong cytochrome P 450 3A (CYP3A) inhibitor within 7 days prior to the first dose of ibrutinib or subjects who require continuous treatment with a strong CYP3A inhibitor
Patients who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or patients who require continuous treatment with a strong CYP3A inhibitor with the exception of voriconazole, which will be specifically studied in this protocol
Chronic treatment (i.e. >7 days) with a strong Cytochrome P450 (CYP3A) inhibitor which cannot be terminated prior to the first dose of ibrutinib.
Patients who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or patients who require continuous treatment with a strong CYP3A inhibitor
Concomitant treatment with strong inhibitor of P-gp.
Concomitant treatment with strong cytochrome P450 3A4/cytochrome P450 3A5 (CYP3A4/5) inhibitor
Requires chronic treatment with strong CYP3A inhibitors; if patients have been on a strong CYP3A inhibitor in the past, they will not be eligible if the CYP3A inhibitor was administered within 7 days of the first dose of study drug
Subjects who received a strong cytochrome P450 family 3 subfamily A (CYP3A) inhibitor within 7 days prior to the first dose of study drug, or patients who require continuous treatment with a strong CYP3A inhibitor are not eligible
Use of a strong CYP3A4 inhibitor within three elimination half-lives of the inhibitor prior to the start of study treatment.
Patients who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or patients who require continuous treatment with a strong CYP3A inhibitor
Current or anticipated use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BCRP.
Concurrent use of a strong CYP3A inhibitor. Subjects who have received a strong CYP3A inhibitor prior to entering the study must have discontinued therapy for at least 5 half lives of the prohibited medication.
Requirement for medication with strong CYP3A4 inhibitor
Treatment with gemfibrozil (or other strong CYP2C8 inhibitor) within 14 days before the first dose of TAK-580.
Patients must not be receiving any strong CYP3A4 or P-glycoprotein (P-gp) inducers or inhibitors within 7 days prior to enrollment; moderate inducers or inhibitors of CYP3A4 and P-gp should also be avoided during ABI-009 treatment, if possible
Strong CYP1A2 inhibitors: Patients must not have received strong CYP1A2 inhibitors (ciprofloxacin, fluvoxamine, zafirlukast) for at least 7 days prior to enrollment and must not receive them for the duration of the study
Patients who have received drugs that are strong inducers of CYP3A4 within 14 days prior to study enrollment are not eligible; while on study, concomitant use of strong CYP3A4 inhibitors, BCRP inhibitors (cyclosporine, eltrombopag, gefitinib), and UGT1A1 inhibitors, (diclofenac, ketoconazole, probenecid, silibinin, nilotinib and atazanavir) should be avoided
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
No strong inducers of cytochrome P450 (CYP) 3A4 or CYP1A2 or strong inhibitors of CYP3A4 or CYP1A2 within 14 days prior to registration\r\n*Note: Ixazomib is a substrate of CYP3A4 and CYP1A2
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): No strong inducers of cytochrome P450 (CYP) 3A4 or CYP1A2 or strong inhibitors of CYP3A4 or CYP1A2\r\n* Note: Ixazomib is a substrate of CYP3A4 and CYP1A2
Patients should not require chronic use of strong CYP3A inhibitors or strong CYP3A inducers
Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study; Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
Patients who require chronic treatment with strong CYP3A4/5 inhibitors =< 14 days prior to registration are not eligible\r\n* NOTE: patients who are currently on treatment with strong CYP3A4/5 inhibitors may be eligible if they are able to be switched to an alternative therapy that is not a strong CYP3A4/5 inhibitor prior to registration on study
Receipt of strong CYP3A inhibitors or inducers (for treatment phase)
Concomitant use of strong inhibitors of CYP3A
Strong inhibitors (eg, ketoconazole) or inducers (eg, rifampicin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study)
Strong inhibitors and strong inducers of CYP3A4 should not be used concomitantly.
Use of strong CYP3A4 inhibitors or strong inducers within 7 days prior to the start of study treatment and for the duration of the study
Is receiving treatment with medication(s) that are known to be strong inhibitors or inducers of CYP3A4/5.
Ongoing treatment with CYP3A4 inducers or strong inhibitors.
Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have received these medications within 1 week prior to study entry; these include:
Participants receiving any medications or substances that are known to be strong inhibitors of CYP1A2, CYP2D6, and CYP3A4 or strong inducers of CYP3A4 are ineligible;
Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
Treatment with strong CYP3A inducers within 14 days prior to the first dose of study treatment of RO6870810/venetoclax.
Treatment with strong CYP3A4/5 inhibitors or inducers
known strong CYP3A inhibitors .
known strong CYP3A inducers
Concomitant medications:\r\n* Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study\r\n* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment\r\n* Patients requiring anticoagulation must be on stable dose of medication prior to registration
Participant requires treatment with concomitant drugs that are strong inducers of CYP3A within 14 days of start of study drug.
Participant requires treatment with concomitant drugs that are strong inducers of CYP3A within 14 days of starting study drug.
Currently using concomitant medications that are strong inhibitors or inducers of CYP3A4.
Drug interactions: Concomitant administration of strong CYP3A4/5 inhibitors or inducers is prohibited while on therapy; patients must not have received these medications for a minimum of 10 days prior to enrollment
Use of medications that are known to be strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
Part B1 only: No concomitant medications that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) or midazolam
Patients receiving concomitant treatment with strong CYP3A4 inhibitors within 3 days of start of study therapy (including posaconazole and voriconazole).
Requires chronic treatment with strong CYP3A inhibitors
Known intermediate or strong CYP3A4 or CYP2C8 inhibitors or inducers within 14 days prior to first dose of study treatment
STRATUM A: Participants who are receiving known strong inducers and/or strong inhibitors of CYP3A4/5, drugs that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5, and medications that carry a known risk for QT prolongation must discontinue these drugs at least 7 days prior to study enrollment
STRATUM B: Participants who are receiving known strong inducers and/or strong inhibitors of CYP3A4/5, drugs that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5, and medications that carry a known risk for QT prolongation must discontinue there drugs at least 7 days prior to study enrollment
STRATUM C: Participants who are receiving known strong inducers and/or strong inhibitors of CYP3A4/5, drugs that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5, and medications that carry a known risk for QT prolongation must discontinue there drugs at least 7 days prior to study enrollment
Patients receiving CYP3A substrates with narrow therapeutic indices, strong CYP3A inhibitors, and strong CYP3A inducers.
Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency
Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency.
Concomitant use of strong CYP3A4 inhibitors and inducers.
Has treatment with strong cytochrome P 3A (CYP3A) inducers within 14 days before the first dose of pevonedistat.
Participants who are receiving strong CYP3A4 inhibitors and inducers.
Current and concurrent use of strong CYP3A4 inhibitors or inducers.
Patients receiving medications that are strong CYP3A4 inhibitors or inducers are ineligible; concomitant use of strong CYP3A4 inhibitors with T-DM1 should be avoided; consider an alternate medication with no or minimal potential to inhibit CYP3A4
Patients taking strong CYP3A4 inhibitors or inducers with risk X (avoid combination) according to lexicomp
Received strong CYP3A inhibitors or strong CYP3A inducers within 7 days of starting venetoclax
Strong CYP3A4 inhibitors
Subjects who are receiving strong CYP3A4 inhibitors or CYP3A4 inducers
Receiving medications that are strong inhibitors or inducers of CYP3A4 (Appendix D).
No strong inducers of CYP3A4 (see Appendix 13.5) within 2 weeks prior to first study treatment.
Is currently using (i.e., within 14-days prior to first dose) drugs that are known strong CYP3A4/5 inhibitors / inducers.
Planned ongoing treatment with another drug that may potentially have adverse interactions with brentuximab vedotin; if such a drug has been used, it must be discontinued at least 1 week prior to initiating study treatment; examples of potential interactions include:\r\n* Coadministration of strong inhibitors of CYP3A4 (eg, ketoconazole, ritonavir, clarithromycin)\r\n* Coadministration of CYP3A4 inducers (eg, rifampin)\r\n* Concomitant treatment with strong inhibitors of P-glycoprotein (P-gp)
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with study drug and for the duration of participation:\r\n* Medication with a significant known risk of prolonging the QT interval or inducing Torsades de Pointes\r\n* Strong inhibitors or strong inducers of CYP3A4/5 \r\n* Herbal supplements
Requires treatment with strong cytochrome P450 3A (CYP3A) inhibitors
Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4)
Any foods/supplements that are strong inhibitors or inducers of CYP3A are prohibited at least 7 days prior to initiation of and during study treatment
Strong inducers of cytochrome P450 3A4 (CYP3A4) are not permitted starting day -14 of cycle 1
Treatment with strong CYP3A4 and CYP2C19 inhibitors and/or inducers must be discontinued at least 1 week before administration of the first dose of study drug
Concurrent therapy with drugs known to be strong inhibitors of cytochrome P450 1A2 (CYP1A2), cytochrome P450 2D6 (CYP2D6), and cytochrome P450 3A4 (CYP3A4), or strong inducers of CYP3A4
known to be strong inducers or inhibitors of CYP3A4/5 (for single agent part); known to be moderate to strong inducers or inhibitors of CYP3A4/5 (for combination part)
CAPMATINIB EXCLUSION CRITERIA: Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of capmatinib treatment and for the duration of the study:\r\n* Strong and moderate inhibitors of CYP3A4\r\n* Strong inducers of CYP3A4\r\n* Proton pump inhibitors (PPI)
Strong inducers or inhibitors of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John?s Wort).
Strong inducers of CYP3A4
Medications or supplements that are known to be strong CYP3A mechanism based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drug. In general, the use of these agents is not permitted during the study except for AE management.
Newly diagnosed MCL: Requires treatment with strong CYP3A4/5 inhibitors
Patients who require medications that are strong CYP3A4 inhibitors or inducers
Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment
REGISTRATION TO TREATMENT (STEP 1): Patients should not be receiving concomitant strong CYP3A4 inducers or inhibitors =< 7 days prior to registration
REGISTRATION TO TREATMENT (STEP 2): Patients should not be receiving concomitant strong CYP3A4 inducers or inhibitors =< 7 days prior to registration
Current treatment with a combination of ibrutinib and strong CYP3A inhibitors
Treatment with strong CYP3A inhibitors or inducers within 14 days before the first dose of study drug; strong CYP3A inhibitors/inducers are not permitted during the study, including nutraceutical preparations, e.g., grapefruit juice and St John’s wort; patients must have no prior history of amiodarone in the 6 months prior to the first dose of pevonedistat
Requires treatment with strong cytochrome P4503A (CYP3A) inhibitors.
Administration of strong CYP2C8 or CYP3A4 inhibitors or inducers =< 10 days prior to registration
Patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; Note: Dexamethasone for CNS tumors or metastases, on a stable dose, is allowed
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
Treatment with strong inhibitors or inducers of CYP3A are prohibited from 14 days prior to the first dose of tazemetostat to the end of the study
Patients must not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, strong CYP3A4 inhibitors and/or strong CYP3A4 inducers; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution
Strong inducers of CYP3A4 are prohibited
requires treatment with strong CYP3A inhibitors
Requires treatment with strong CYP3A inhibitors Exclusion Criteria for Phase 2 Sub-study Cohort:
Patients treated within the last 7 days prior to randomization and/or concurrent use of drugs known to be strong CYP3A4 inhibitors or inducers (see appendix 21.3)
Concomitant treatment with strong inhibitors or inducers of CYP3A4 and P-glycoprotein
Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
Patients taking strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) who cannot interrupt therapy from the time the C-13 consent is signed through 30 days after the last dose of study therapy.
Requires treatment with strong CYP3A inhibitors
Treatment with strong CYP3A4 inhibitors or inducers
Seizures Patients who are currently receiving enzyme inducing anti-epileptic drugs that are known strong inducers or inhibitors of CYP3A4/5 (EIAEDs). Patients with a history of seizures and maintained on an anti-epileptic drug that is not a strong inducers or inhibitor of CYP3A4/5 are eligible.
Strong CYP3A4/5 inducers or inhibitors
Known strong inducers or inhibitors of CYP3A4/5,
Concomitant use of CYP3A4 strong inducers and strong inhibitors
Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization (Part 2).
Concurrent use of any strong inducers or strong inhibitors of CYP3A4
Patients requiring medications that are strong inducers or strong inhibitors of CYP3A4
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 CYP3A.
The following concomitant medications are not allowed from 7 days prior to the first dose of study drug and during venetoclax administration: strong CYP3A4 inhibitors including but not limited to fluconazole, ketoconazole, and clarithromycin or strong CYP3A4 inducers included but not limited to rifampin, carbamazepine
Is receiving concomitant therapy with strong CYP3A4 or CYP2A6 inhibitors or inducers
Requires treatment with strong cytochrome P450 3A (CYP3A) inhibitors
Patient is taking a drug known to be a strong inhibitor or inducers of the isoenzyme cytochrome P450, family 3, subfamily A (CYP3A); participants must be off a strong CYP3A inhibitors and inducers for at least two weeks prior to starting the study drug
Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 2 weeks before the first dose of study drug (See Appendix F for list of excluded drugs)
Strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4), strong inhibitors of cytochrome P450 1A2 (CYP1A2), or CYP3A4 substrates with a narrow therapeutic range within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
Patients requiring strong CYP3A4 inducers or inhibitors are excluded
Administration of medications or foods that are strong inhibitors or inducers of CYP3A within 2 weeks of randomization
Requires treatment with strong CYP3A inhibitors
That are known strong inducers or inhibitors of CYP3A4.
Requires treatment with strong CYP3A inhibitors
Concomitant use of strong CYP3A4 inhibitors
Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have received these medications within 1 week of entry
Strong inhibitors or inducers of CYP3A4
Patients who are receiving treatment with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to study entry
Required treatment with certain strong CYP3A4 inhibitors or inducers.
Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 weeks before the date of randomisation.
Participants who are taking strong CYP3A4 inhibitors
Requires treatment with strong cytochrome (CYP3A4/5) inhibitors
strong CYP3A4 inhibitors, or
Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.
Patients who are taking medications that are strong inducers or inhibitors of CYP3A4
Subjects currently taking medications known to be strong CYP3A4 inhibitors.
Concomitant therapy with strong CYP3A4 inhibitors or inducers
Strong CYP3A4 inhibitors or inducers as well as inhibitors of breast cancer resistance protein (BCRP) within 14 days or 5 drug half-lives, whichever is longer, before start of study drug.
Patients who require strong CYP3A inducers at the time of study enrollment are excluded; for patients who can safely discontinue prior strong CYP3A inducers, a wash-out period of 5 effective half-lives is required prior to 1st dose of ibrutinib
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
Subjects taking or likely to take strong and moderate CYP2D6 inhibitors, strong CYP1A1 inhibitors, and/or CYP1A1/CYP1A2 sensitive substrates or with narrow therapeutic index. Subjects receiving oral BAY1143269 and IV docetaxel must not take or be likely to take strong CYP3A1 inhibitors
Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug.
No concurrent strong CYP3A4 inducers or inhibitors.
Receiving treatment with medications that are known strong inhibitors or inducers of CYP3A, and cannot be discontinued 7 days prior to the start of the treatment and during the course of the study.
The subject requires chronic concomitant treatment of strong CYP3A4 inhibitors
Requirement for treatment with any of the prohibited medications including strong CYP3A inhibitors, strong CYP3A inducers, CYP3A substrates with a narrow therapeutic index, and medications with strong risk of QT prolongation
Concurrent therapy with drugs known to be strong inhibitors of CYP1A2, CYP2D6, and CYP3A4, or strong inducers of CYP3A4
Requires treatment with strong CYP3A inhibitors.
Use of strong Cytochrome P450 3A4 (CYP3A4) inducers while on study medication
Currently receiving medications known to be strong inducers or inhibitors of CYP3A4 with a narrow therapeutic window. Strong inducers and inhibitors of CYP3A4 with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug.
Subject requiring concomitant use of strong CYP3A4 inhibitors or inducers.
Strong inhibitors and potent inducers of CYP3A4
Narrow Therapeutic index substrates, strong inhibitors and strong inducers of CYP3A4
Patients who are concurrently receiving strong inducers/inhibitors of CYP3A
Receiving strong CYP3A4 inhibitors/ inducers.
Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of treatment
Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment
Further, patients treated with medications that were known to be strong inhibitors or inducers of CYP3A4/5 that could not be discontinued at least a week prior to start of treatment with LDK378 and for the duration of the study were also excluded.
Strong inhibitors or inducers of CYP3A4
Patients requiring chronic treatment with strong CYP3A inhibitors
Medications or supplements that are known to be strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drug. The use of these agents is not permitted during the study. See a list of prohibited strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers based on the US FDA Draft DDI Guidance.
Use of strong CYP3A4 or CYP2C8 inhibitors or inducers or presence of any other contra indications for irinotecan
Patient requires treatment with strong CYP3A4 inhibitors or moderate or strong CYP3A4 inducers other than those required for GVH or infection prophylaxis or treatment
Patients on strong CYP3A4 inducers or inhibitors that cannot be discontinued
Subjects taking strong CYP3A4 and CYP2C19 inhibitors and/or inducers should be considered with caution; alternative treatments that are less likely to affect MLN0128 (TAK-228) metabolism, if available, should be considered; if a subject requires treatment with 1 or more of the strong CYP3A4 and CYP2C19 inhibitors and/or inducers, the study doctor should be consulted
Treatment with Strong inhibitors or inducers of CYP3A4 within 2 weeks prior to receiving study drug
Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A
Medications or supplements that are known to be strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drug. In general, the use of these agents is not permitted during the study except in cases in which an AE must be managed during interruption of study drug dosing.
Medications or supplements that are known to be strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days, or within 5 times the inhibitor or inducer half-life (whichever is longer), before the first dose of study drug. The use of these agents is not permitted during the study.
A guidance regarding potential interactions with concomitant medications is provided
Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study
Use of protocol-defined prior/concomitant therapy.
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
Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable)
Concomitant medication restrictions:
Concomitant medication restrictions
Concomitant medications with another A1R antagonist that would increase the risk of seizure (e.g., theophylline, aminophylline).
concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates
Concomitant diseases/conditions:
Uncontrolled concomitant disease
Concomitant second malignancies
EXCLUDED THERAPIES AND MEDICATIONS, PREVIOUS AND CONCOMITANT
Previous and concomitant therapy that precludes enrollment, as defined in the protocol
Concomitant use of the strong CYP2C8 inhibitors gemfibrozil or trimethoprim (Bactrim)
Concomitant treatment with other anti-neoplastic agents, with the exception, when clinically indicated, of prophylaxis in the post-transplantation setting with intrathecal chemotherapy
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
Subjects with concomitant second malignancies
Have a serious concomitant systemic disorder.
Use of protocol-defined prior/concomitant therapy.
Any of the following concomitant diseases/conditions:
Patients receiving any concomitant systemic therapy for renal cell cancer are excluded.
Concomitant Medications:
Uncontrolled concomitant disease
Patients receiving prohibited concomitant medications that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever is longer, prior to the start of pazopanib treatment.
Concomitant use of other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for palliative), biological therapy or other novel agent) or live virus and live bacterial vaccines while the patient is receiving study medication. Strong or moderate CYP3A inhibitors and inducers should not be taken with study treatment; however, if no other suitable alternative concomitant medication is available, dose reductions may be allowed under careful monitoring
Uncontrolled concomitant disease
Serious concomitant systemic disorder.
Concomitant use of other cytotoxic or cytostatic drugs other than PTX
Patients receiving any concomitant systemic therapy for renal cell cancer are excluded
Have a serious concomitant systemic disorder.
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Anticipated need for concomitant administration of any other experimental drug, or a concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy during study participation.
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
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
Concomitant use of any anti-cancer therapy or immune modifier.
Uncontrolled concomitant disease
Concomitant therapies for treatment or control of leukemia.
Concomitant medications:
Serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy
Other serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy
Concomitant use of bisphosphonates or RANK-ligand inhibitors is allowed
Patients must be free of other active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy
Concomitant medications, if taken within the last 28 days
Concomitant use of bisphosphonates is allowed
Concomitant medications:
Prior or concomitant systemic anti-cancer treatment for advanced disease
Enrollment in a concomitant clinical study
Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
Concomitant use of medications associated with a high incidence of QT prolongation
Any condition which could jeopardise the safety of the patient and his/her compliance in the study Excluded therapies and medications, previous and concomitant:
Must not require concomitant treatment with anticoagulants
Requirement for any non-study potentially effective concomitant systemic antibacterial therapy
Concomitant use of drugs known to cause QT prolongation (Note: Ondansetron at doses ? 16 mg or less is allowed)
Concomitant radiotherapy
Presence of any serious or unstable concomitant systemic disorder incompatible with\n             the clinical study
No concomitant use of alternative complimentary therapies or over the counter (OTC) agents allowed without prior approval of the principal investigator (PI)
Have, at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only; Ta/T1 high-grade disease with concomitant CIS; or Ta/T1 high-grade disease without concomitant CIS
Prior/Concomitant Therapy
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Use of protocol-defined prior/concomitant therapy.
Other concomitant malignancies (with some exceptions per protocol)
Other concomitant malignancies (with some exceptions per protocol)
Any concomitant systemic therapy or radiation therapy initiated for this malignancy.
Life expectancy severely limited by concomitant illness or uncontrolled infection
Evidence of any significant, uncontrolled concomitant disease
Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
No concomitant approved anti-cancer therapies or any investigational agents
Use of protocol-defined prior/concomitant therapy.
Use of protocol-defined prior/concomitant therapy.
Use of protocol-defined prior/concomitant therapy.
Use of protocol-defined prior/concomitant therapy.
Concomitant diseases/conditions:
Concomitant treatment with:
No planned concomitant, non-protocol directed anti-cancer therapy
Have clinical evidence of concomitant infectious conditions.
Concomitant medications causing prolonged QT which cannot be discontinued or changed to a different medication prior to initiating study
Concomitant use of antithrombotic agents with the exception of platelet inhibitors.
Concomitant malignancies
Patients must be able to follow concomitant medication restrictions:
Previous or concomitant malignancies at any other site with the exception of the following:
Evidence of significant, uncontrolled concomitant disease
Is receiving concomitant treatment with drugs that may interact with capecitabine
Patients requiring concomitant medications that are not able to be switched to a reasonable alternative
Patients must not receive concomitant radiation
Have a serious concomitant systemic disorder or significant cardiac disease.
Concomitant therapy medications that include corticosteroids (except as indicated in inclusion criteria)
Concomitant use of additional anti-neoplastic agents will not be allowed in this study
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)
Concomitant therapy with immune-suppressants or chronic use of systemic corticosteroids
There must be no plans to receive concomitant chemotherapy, biological response modifiers, radiation therapy or hormonal therapy; concomitant radiation therapy is allowed for the palliation of severe pain/neuropathic compression
Prior or concomitant use of megestrol acetate for the treatment of hot flashes is allowed
Concomitant use of medications that may alter pharmacokinetics of enzalutamide
EXCLUDED THERAPIES AND MEDICATIONS, PREVIOUS AND CONCOMITANT
Excluded therapies and medications, previous and concomitant:
Concomitant therapy that precludes enrollment, as defined in the protocol
Patients with concomitant disease know to get influence on bone metabolism
Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
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
Any other concomitant anti-cancer treatment.
Concomitant therapy with bisphosphonates is allowed
Serious concomitant systemic disorder
Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol.
Concomitant medications should be avoided (when possible) while on study
Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol; concomitant use of corticosteroids is permitted as clinically indicated
Concomitant use of bisphosphonates is allowed
Concomitant use of foscarnet, liposomal amphotericin B or aminoglycoside
Concomitant malignancy;
Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Serious concomitant conditions
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 .
Concomitant treatment with chemotherapeutic agents for diseases other than malignancy
Participants who take medications that are not recommended for concomitant use with their current antiretroviral regimen
Concomitant treatment with other anti-neoplastic agents, with the exception of hydroxyurea
Subject requires the use of the following concomitant treatments/procedures at any time, per protocol.
Concomitant use of phosphodiesterase inhibitors
Received concomitant Temozolomide
Concomitant CRT completed prior to randomisation
Patients who are receiving concomitant systemic therapy for breast cancer
Patients receiving concomitant radiotherapy or immunotherapy
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
Other concomitant anti-tumor therapy as determined by the study team.
Concomitant diseases/conditions
Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM
Serious concomitant systemic disorders
Other concomitant malignancies (with some exceptions per protocol)
Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
Concomitant chemotherapy or radiotherapy is not permitted.
Other concomitant malignancies (with some exceptions per protocol)
Any concomitant disease or condition which would interfere with the subjects' proper completion of the protocol assignment.
Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism, Paget's disease of bone, or any other concurrent severe or uncontrolled concomitant medical condition that, in the opinion of the Investigator, would preclude participation in this study
Other active concomitant malignancy that warrants systemic therapy
Other active concomitant malignancy that warrants systemic therapy
Patients who are on concomitant treatment with drugs that are contraindicated in this study and that cannot be discontinued within the time frames
Concomitant medications that are known inducers of CYP.
For patients enrolled into Stage I, they must have received at least 75% of planned radiotherapy (60 Gy) with temozolomide treatment during the concomitant phase have documentation that the patient's absolute neutrophil count (ANC) is ? 1.5 x 109/L, platelet count is ? 100 x 109/L, and there was no CTC grade 2 or above nonhematological toxicity (except for alopecia, nausea, vomiting) during the concomitant phase treatment be within ? 4 weeks but ? 6 weeks following the completion of temozolomide in the concomitant phase
Concomitant chemotherapy or radiotherapy is not permitted.
The patient has (or has had) previous or concomitant malignancies, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
Concomitant enrollment in a Phase I study
Presence of previous or concomitant neoplasm with exclusion of in situ cervical cancer
NOTE: concomitant treatment with ongoing trastuzumab (Herceptin) or other targeted/biologic agents is allowed; concomitant treatment with any other type of chemotherapy or hormonal therapy is not allowed
Concomitant use of medications that may alter pharmacokinetics of abiraterone or apalutamide
Concomitant malignancies
Subjects with chronic kidney disease or concomitant parathyroid disease
No other concomitant therapy directed at the cancer is allowed
Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors, within 2 weeks of Study Day 0, exclusive of steroid doses ? 5 mg daily.
Concomitant panniculectomy or plastic surgery
Concomitant use of medications known to induce a disulfiram-like reaction to alcohol
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
Concomitant biologic, hormonal, or radiation therapy are acceptable
Severe concomitant illnesses
Concomitant use of oral cyclosporine
Women who are receiving any other concomitant treatment for their DCIS/ADH
Concomitant corticosteroids or anticoagulants needed on a regular or predictable intermittent basis
Severe concomitant illnesses
Concomitant investigational therapy
Concomitant investigational therapy
No concomitant infection or other serious major systemic illness
Concomitant cyclosporine, gemfibrozil, telaprevir, or tipranavir/ritonavir use
Other concomitant malignancies (with some exceptions per protocol)
Concomitant diseases/conditions:
Concomitant medications:
Co-medication or concomitant therapy that may interfere with study results
Concomitant systemic use of anticancer herbal medications. These should be stopped prior to study entry.
Patients required to be on any of the concomitant medications are excluded
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
Exposure to potent or moderate inhibitors or inducers of CYP3A4/5 and CYP2C8 if taken within the stated washout periods before the first dose
Concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of CYP3A4
Concurrent use of potent CYP3A4 inhibitors, such as ketoconazole and erythromycin, should be avoided during the study treatment with T-DM1
Subjects must not be receiving potent CYP3A4 inducers or inhibitors
Patients currently receiving and unable to stop using medications known to be potent inhibitors or inducers of CYP3A4
Patients currently receiving and unable to stop using medications known to be potent inhibitors or inducers of CYP3A4
Concurrent use of potent CYP3A4 inhibitors, such as ketoconazole and erythromycin, should be avoided during the study treatment with nab-paclitaxel
Use of potent inhibitors or inducers of cytochrome P450 enzymes CYP3A4 within 14 days prior to first study drug administration.
Concomitant therapy with potent inhibitors of CYP450 3A4 (e.g. ketoconazole, verapamil etc) or with potent CYP450 1A2 inhibitors (fluoroquinolone antibiotics including ciprofloxacin, levofloxacin, and norfloxacin; ticlopidine, cimetidine, amiodarone, etc.)
The patient has taken a medication known to be a potent inhibitor of CYP1A2, CYP2C8, or CYP3A4 within 2 weeks prior to the first dose of study drug
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)
Concomitant use of potent CYP3A4/5 inhibitors during the treatment phase of the study and within 72 hours prior to starting study drug administration.
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
Concomitant use of potent CYP3A4/5 inhibitors during the treatment phase of the study and within 72 hours prior to starting study drug administration
Only for subjects enrolled in Arm 1 - Neratinib and everolimus: patients who are taking medications with moderate or potent inhibitors or inducers of CYP450 3A4 should be off for 5 half-lives prior to starting everolimus.
Subjects being treated concurrently with any prohibited medications, including investigational medication, rifampin, St. John's wort, and potent CYP3A4 inhibitors (excluding ketoconazole) unless continuation of such medications are determined by the investigator to be in the best interest of the patient
Medical need for the continued use of potent inhibitors/inducers of CYP3A4
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 inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior) will only be eligible at the principal investigator's (PI’s) discretion
Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
PHASE II: Concomitant use of known potent CYP3A4 inhibitors
Subjects currently receiving (or unable to stop using prior to receiving the first dose of trial drug) medications or herbal supplements known to be potent inhibitors of cytochrome P450 (CYP)3A or CYP2C19 (must stop at least 1 week prior), potent inducers of CYP3A or CYP2C19 (must stop at least 3 weeks prior), or drugs mainly metabolized by CYP3A with a narrow therapeutic index (must stop at least one day prior).
Subjects currently receiving (or unable to stop using prior to receiving the first dose of study drug) medications or herbal supplements known to be potent inhibitors of CYP3A or CYP2C19 must stop at least 1 week prior to taking MSC2490484A. Subjects receiving potent inducers of CYP3A or CYP2C19 must stop at least 3 weeks prior to taking MSC2490484A. Those receiving drugs mainly metabolized by CYP3A with a narrow therapeutic index as judged by the Investigator (and after optional consultation with the Sponsor) must stop at least one day prior to taking MSC2490484A.
Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers, and drugs that are known to prolong the QT interval
Patients taking a potent CYP3A4 inhibitor that cannot be changed to an alternate drug.
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
No concomitant medications such as phenytoin, carbamazepine, rifampicin, barbiturates, ketoconazole and itraconazole, which are potent inducers of CYP3A4 or potent inhibitors of CYP3A4
Subjects who are currently receiving prescription or non prescription medications or other products known to be moderate or potent inhibitors/inducers of CYP3A4, P-gp, or CYP2C8.
Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers, and drugs that are known to prolong the QT interval.
Concomitant use of potent P450 3A4 (CYP3A4) inducers
Patients requiring comedication with potent P-glycoprotein (P-gp) inhibitors (including cyclosporine, azithromycin, erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital salt with quinidine, ritonavir, valspodar, verapamil) or inducers (including rifampicin)
The use of potent phospho-glycoprotein (P-gp) inhibitors (including cyclosporine, erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital salt with quinidine, ritonavir, valspodar, verapamil) and potent P-gp inducers (including St John's wort, rifampicin) must be avoided during treatment with afatinib
Current use or anticipated inability to avoid potent CYP3A4/5 inhibitors or inducers (please refer to the Inlyta® [axitinib] prescribing information) during participation in the study.
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
Subjects taking medications that are known potent or moderate inducers/ inhibitors of CYP3A4 (including St. John's Wort)
Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of AZD3759/AZD9291) medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 3A4/5 and potential inhibitors of cytochrome P450 2C8 (for patients to be enrolled into AZD9291 cohorts only).
Use of potent CYP3A4 inhibitors or inducers
Exposure to potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment
Received potent cytochrome P450 3A4 (CYP3A4) inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of study treatment
Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4.
Potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort).
The use of potent permeability glycoprotein (P-gp) inhibitors (including cyclosporine, erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital salt with quinidine, ritonavir, valspodar, verapamil) and potent P-gp inducers (including St John's wort, rifampicin) has to be avoided during treatment with afatinib; any exemptions to this have to be discussed with the principal investigator
Potent inhibitors of cytochrome P450 3A4 (CYP3A4)
Use of oral anticoagulants. Use of subcutaneous anti coagulation is allowed. Concurrent use of potent or moderate inhibitors or inducers of CYP3A4 and/or CYP2C8.
Major surgery within 4 weeks prior to study day 1 Active infection Anti-coagulation therapy Concomitant treatment with potent CYP3A4 inducers
Use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4
Subjects currently receiving or unable to stop using medications or herbal supplements known to be potent inhibitors of cytochrome P450 (CYP) 3A and / or P-glycoprotein (P-gp) (CYP and / P-gp must stop at least 1 week before treatment with M3541) or potent inducers of CYP3A or P-gp (must stop at least 3 weeks before treatment with M3541) or drugs mainly metabolized by CYP3A with a narrow therapeutic index (must stop at least 1 day prior).