Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 enzymes are ineligible; these include St. John’s wort or hyperforin (potent CYP3A4 enzyme inducer) and grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor); such substances can significantly increase or decrease the serum level of cobimetinib; 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
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
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or moderate inhibitors of CYP3A4 are ineligible; the study team should check a frequently-updated medical reference for a list of drugs to avoid or minimize use of; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; dihydropyridine calcium-channel blockers are permitted for management of hypertension; patient drug information handout and wallet card should be provided to patients
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
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
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 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)
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
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 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
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 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
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
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
Concomitant use of known potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
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
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
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
CYP3A4 inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed
Concomitant medications\r\n* Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible\r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\r\n* CYP3A/CYP3A4 agents: patients who are currently receiving drugs that are strong and moderate inducers or inhibitors of CYP3A or CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 21 days prior to enrollment to the end of the study
Patients who are currently receiving drugs that are moderate to strong inducers or inhibitors of CYP3A4 are not eligible; moderate to 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
Concomitant medications\r\n* Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible\r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\r\n* CYP3A4 agents: patients who are currently receiving drugs that are strong inducers or strong 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\r\n** Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
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
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 receiving any medications or substances that are potent inhibitors or inducers of
Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil); the required washout period prior to starting olaparib is 2 weeks; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients 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
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to treatment start:\r\n* Known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 4 (5), including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\r\n* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\r\n* That have a known risk to prolong the QT interval or induce Torsades de Pointes\r\n* Herbal preparations/medications, dietary supplements
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
Participants receiving any medications or substances that are inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; 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 patient is considering a new over-the-counter medicine or herbal product
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
Unable or unwilling to discontinue use of any drug known to be a strong or moderate inhibitor or inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to first dose of study drug); unable or unwilling to discontinue use of any proton pump inhibitor
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
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
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
Strong inhibitors and strong or moderate inducers of 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
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
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients should not have received the following within 7 days prior to the first dose of study drug:\r\n* Steroid therapy for anti-neoplastic intent;\r\n* Strong and moderate CYP3A inhibitors;\r\n* Strong and moderate CYP3A inducers
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients should not have received the following within 7 days prior to the first dose of study drug:\r\n* Steroid therapy for anti-neoplastic intent;\r\n* Strong and moderate CYP3A inhibitors;\r\n* Strong and moderate CYP3A inducers
Receipt of strong CYP3A inhibitors or inducers (for treatment phase)
Concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of CYP3A4
Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) and grapefruit, grapefruit juice or any product containing grapefruit, or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil); the required washout period prior to starting olaparib is 2 weeks
Receiving any medications or substances that are strong or moderate inhibitors of CYP3A4; use of strong or moderate inhibitors are prohibited =< 7 days prior to randomization
Receiving any medications or substances that are inducers of CYP3A4; use of inducers are prohibited =< 7 days prior to randomization
Inclusion criteria:\n\n        Parts A, B, C and D:\n\n          -  Patients must be postmenopausal women\n\n          -  Histological diagnosis of breast adenocarcinoma\n\n          -  Locally advanced or metastatic disease\n\n          -  Measurable disease\n\n          -  Previously treated for advanced disease\n\n          -  Either primary tumor or any metastatic site to be positive for Estrogen Receptors\n             (ER+) and negative for human epidermal growth factor receptor 2 (HER2-) by\n             immunohistochemistry (IHC)\n\n        Exclusion criteria:\n\n          -  Medical history or ongoing gastrointestinal disorders that could affect absorption of\n             SAR439859 and/or palbociclib (including difficulties with swallowing capsules)\n\n          -  Patient with any other cancer (except for adequately treated basal cell or squamous\n             cell skin cancer, in situ cervical cancer or any other cancer from which the patient\n             has been disease free for >3 years)\n\n          -  Patients with known brain metastases and endometrial disorders\n\n          -  Treatment with anticancer agents (including investigational drugs) less than 2 weeks\n             before first study treatment starts (less than 4 weeks if the anticancer agents were\n             antibodies)\n\n          -  Prior treatment with another selective ER down-regulator (SERD) (except fulvestrant)\n\n          -  Inadequate hematological and biochemical lab tests\n\n          -  Patients with Gilbert disease\n\n          -  Treatment with human immunodeficiency virus (HIV)-antiviral, antifungal and\n             antioxidant agents less than 2 weeks before study treatment starts\n\n          -  Treatment with strong and moderate CYP3A inducers/inhibitors within 2 weeks before\n             first study treatment\n\n        Part A only:\n\n        Patients with liver metastases only\n\n        Parts C and D only:\n\n          -  Prior therapy with any selective cyclin-dependent kinase (CDK) 4/6 inhibitor\n\n          -  Treatment with strong and moderate CYP3A inducers or strong CYP3A inhibitors within 2\n             weeks before first study treatment starts\n\n          -  Medical conditions requiring concomitant medications with that are metabolized by\n             CYP3A\n\n        The above information is not intended to contain all considerations relevant to a patient's\n        potential participation in a clinical trial.
Currently receiving any of the following medications and cannot be discontinued 7 days prior to starting the study\r\n* Herbal supplements including grapefruit, grapefruit hybrids, pummelos, star-fruit, Seville oranges or products containing the juice of each; orange juice is allowed\r\n* Known strong inducers or inhibitors of CYP3A4/5 including grapefruit, grapefruit hybrids, pomelos, star-fruit, and Seville oranges\r\n* Medications known to have a narrow therapeutic window and are predominantly metabolized through CYP3A4
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
Concomitant use of strong inhibitors of CYP3A
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 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
Strong inhibitors and strong inducers of CYP3A4 should not be used concomitantly.
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
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
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.
In general, the use of any concomitant medication deemed necessary for the care of the patient is permitted in this study, except as specifically prohibited below; combination administration of study drugs could result in drug-drug interactions (DDI) that could potentially lead to reduced activity or enhanced toxicity of the concomitant medication and/or ribociclib; patient is currently receiving any of the following medications and cannot discontinue use within 7 days prior to starting study drug:\r\n* Known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\r\n* Herbal preparations/medications\r\n* Dietary supplements
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
Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C19 or CYP2C9 within 7 days prior to study registration
Subjects must not be receiving potent CYP3A4 inducers or inhibitors
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
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to treatment:\r\n* Known strong inducers or inhibitors of CYP3A4/5 or bile salt pump efflux, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges;\r\n* That have a known risk to prolong the QT interval or induce torsades de pointes;\r\n* Herbal preparations/medications, dietary supplements;\r\n* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
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)
Patients treated within the last 7 days prior to the start of IP with strong/moderate CYP3A4 inhibitors, strong/moderate CYP3A4 inducers, CYP2C8 inhibitors, strong/moderate CYP2C8 inducers, or drugs that are known to prolong the QT interval.
Patient receiving any of the following medications within 7 days of day 1 of study treatment:\r\n* Known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), including grapefruit, grapefruit hybrids, pomelos, star-fruit, and Seville oranges\r\n* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\r\n* That have a known risk to prolong the QT interval or induce torsades de pointes\r\n* Herbal preparations/medications
Participants receiving any medications or substances that are moderate and strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), including enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days before the first dose of ponatinib will be excluded; this category includes phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, and oxcarbazepine\r\n* NOTE: participants must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to the first dose of study drug and during the entire study treatment period
The use of CYP2C8 and CYP3A4 inhibitors/inducers while not prohibited in this study, is discouraged whenever feasible; concurrent use of strong CYP2C8 and CYP3A4 inhibitors/inducers should be documented and the principal investigator (PI) of the study shall be notified prior to dosing; as part of the enrollment/informed consent procedures, the patients 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
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.
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
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
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
Taking strong inducers or inhibitors of CYP450s for subjects receiving everolimus
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
Is receiving concomitant treatment with a strong inhibitor or inducer of CYP3A4/5.
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
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 that require co-administration of strong or moderate CYP3A inhibitors, as these medications may alter dabrafenib and trametinib concentrations
Participants who require treatment with medications that are strong or moderate CYP3A inducers, as these medications may alter the concentration of trametinib
Require continued treatment with a medication that is known to be a strong inhibitor of CYP3A enzymes. (Treatment with moderate or weak CYP enzyme inhibitors is allowed.)
Require continued treatment with a medication that is known to be a strong inducer of CYP3A.
Treatment with any of the strong CYP2C inducers within 14 days before the first dose of TAK-580
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;
Patients currently receiving and unable to stop using medications known to be potent inhibitors or inducers of CYP3A4
Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
Participant has received the following within 7 days prior to the first dose of study drug: corticosteroid therapy, CYP3A inhibitors, CYP3A inducers.
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 strong to moderate CYP3A inhibitors or moderate CYP3A inducers within 7 days prior to the first dose of study treatment.
Treatment with strong CYP3A inducers within 14 days prior to the first dose of study treatment of RO6870810/venetoclax.
Known strong inducers or inhibitors of cytochrome (CYP)3A4 or P-glycoprotein (P-gp);
Treatment with strong CYP3A4/5 inhibitors or inducers
ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Concurrent use of strong CYP3A4 inhibitors/inducers is prohibited due to drug-drug interactions with palbociclib; moderate CYP3A4 inhibitors/inducers should be used with caution
Prior treatment (< 2 weeks before start of SY-1365) with moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors. See list in Appendix 3
Patients currently receiving and unable to stop using medications known to be potent inhibitors or inducers of CYP3A4
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug:\r\n* Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\r\n* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\r\n* Herbal preparations/medications, dietary supplements; acceptable supplements include multivitamins, vitamin D and calcium\r\n* Angiotensin-converting enzyme (ACE) inhibitor therapy
Participants that require co-administration of strong or moderate CYP3A inhibitors, as these medications may alter vemurafenib and cobimetinib concentrations
Participants who require treatment with medications that are strong or moderate CYP3A inducers, as these medications may alter the concentration of cobimetinib
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 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
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug:\r\n* Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges, that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\r\n* Herbal preparations/medications, dietary supplements
Participants receiving any medications or substances that are strong or moderate inhibitors or inducers of CYP3A4 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
known strong CYP3A inhibitors .
known strong CYP3A inducers
Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) are ineligible
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)
Receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days prior to registration
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
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
Concomitant administration with strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (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; patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A (CYP3A4 enzyme) 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 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
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
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
Treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 inducer within the last 2 weeks
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:
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.
Treatment with strong inhibitors and/or inducers of CYP3A4, CYP2C9, or CYP2C19 within 7 days preceding the first dose of the study drugs.
Requires treatment with a strong cytochrome P450 CYP3A4/5 inhibitor
Use of potent inhibitors or inducers of cytochrome P450 enzymes CYP3A4 within 14 days prior to first study drug administration.
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
Currently using concomitant medications that are strong inhibitors or inducers of CYP3A4.
Taking any medication known to be a moderate or strong inhibitor of the CYP3A4 isozyme or any drugs that are moderate or strong CYP3A4 inducers.
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.
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)
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.
Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A; the patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment; switching to a different medication is allowed
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
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
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)
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
Patients who requires treatment with a strong cytochrome P450 (CYP) family 3, subfamily A (3A) inhibitor
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)
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
Subjects who are currently receiving therapy with a potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer or inhibitor (e.g. clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir)
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
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
Concomitant use of CYP3A4 inhibitors
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 CYP3A4, or CYP3A4 substrates need to be reviewed by the principal investigator; continuation of such medications will be at the discretion of the principal investigator; concomitant use of aprepitant or fosaprepitant is prohibited; as grapefruit and Seville oranges are known to contain moderate inhibitors of CYP3A4, these fruits or their products (including marmalade, juice, etc.) should be avoided while taking AZD1775; the use of sensitive substrates of CYP3A4, such as atorvastatin, simvastatin and lovastatin, is also prohibited in this study; herbal preparations are not allowed throughout the study; these herbal medications include but are not limited to: St. John's wort, kava, ephedra (mahung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng
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 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 strong inhibitors or inducers of CYP3A4 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. Strong inhibitors and inducers of CYP3A4 are prohibited within 2 weeks before the start of and during treatment. Strong inhibitors and inducers of CYP2C8 should be used with caution; the PI of the study is to be consulted regarding their use
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.
Concurrent treatment with a non-permitted drug as well as foods or supplements that are strong or moderate CYP3A4 enzyme inducers or inhibitors. Any of the above has to be discontinued at least 7 days prior to cycle 1/ day 1 of study treatment.
Concomitant use of known strong or moderate CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to 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 CYP3A4/5, and medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, and/or 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 in the 5 days before first dose of study treatment\r\n* Enzyme-inducing anticonvulsive agents
Patients receiving concomitant treatment with strong CYP3A4 inhibitors within 3 days of start of study therapy (including posaconazole and voriconazole).
Received the following agents within 7 days prior to the first dose of venetoclax:\r\n* Steroid therapy for anti-neoplastic intent \r\n* Strong and moderate CYP3A inhibitors \r\n* Strong and moderate CYP3A inducers\r\n* Consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax
Subject has received the following within 7 days prior to the first dose of the study drug:\r\n* Steroid therapy for anti-neoplastic intent\r\n* Strong and Moderate CYP3A inhibitors \r\n* Strong and Moderate CYP3A inducers
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
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
Unable to discontinue use of a strong CYP3A4 inhibitor
Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
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
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
Concurrent therapy with strong inhibitors or inducers of CYP3A4 or CYP2C8 or with sensitive substrates of CYP3A4, CYP2C9 or CYP2C19
Taken a strong inhibitor or inducer of CYP3A4 within 14 days prior to enrollment
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)
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
Subjects who require therapy with a strong CYP3A4 inhibitor prior to enrollment to this study
Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir), moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil), strong CYP3A inducers (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil); a minimum washout period of 2 weeks prior to cycle 1 day 1 is required for strong inhibitors, and at least one week for moderate inhibitors; a minimum washout period of 4 weeks prior to cycle 1 day 1 is required for CYP3A inducers; a minimum washout period of 5 weeks prior to cycle 1 day 1 is required for enzalutamide or phenobarbital; dihydropyridine calcium-channel blockers are permitted for management of hypertension
Any P-glycoprotein (P-gp) inducers/inhibitors or strong cytochrome P4503A (CYP3A) inhibitors within 14 days prior to the first dose of study drug
Consumption of foods, supplements, or drugs that are strong or moderate CYP3A4 enzyme inducers or inhibitors at least 7 days prior to Day 1 of Cycle 1 and during study treatment
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)
Concomitant medications\r\n* Corticosteroids: Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: Patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: Patients who are currently receiving other anti-cancer agents are not eligible\r\n* Anti-GVHD agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\r\n* CYP3A4 agents: 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
Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment; additional details as described in the protocol.
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 CYP3A substrates with narrow therapeutic indices, strong CYP3A inhibitors, and strong CYP3A inducers.
The use of strong CYP3A4 inhibitor (with the exception of ketoconazole).
Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency
Requires treatment with a strong CYP3A4/5 and/or CYP2D6 inhibitor
Currently taking a strong CYP3A inhibitors that cannot be discontinued prior to trial enrollment and for the duration of trial. This includes but is not is limited to: boceprevir clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir.
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.
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 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
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
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.
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.
Strong CYP3A4 inhibitors or inducers should not be used within 3 days of day 1 dosing until the end of study; moderate CYP3A4 inhibitors or inducers should be used with caution
Participants who are receiving strong CYP3A4 inhibitors and inducers.
Patients requiring the following agents within 7 days prior to the first dose of venetoclax are excluded:\r\n* Steroid therapy for anti-neoplastic intent\r\n* Strong CYP3A inhibitors\r\n* Strong CYP3A inducers\r\n* Consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax\r\n* NOTE: moderate CYP3A inhibitors and inducers should be used with caution and an alternative medication used, whenever possible
Patients receiving any medications or substances that are strong inhibitors and/or strong or moderate inducers of CYP3A4 are ineligible
Current and concurrent use of strong CYP3A4 inhibitors or inducers.
Current use or anticipated need for food or drugs that are known strong or moderate CYP3A4 inhibitors, including their administration within 2 weeks prior to the first study treatment (ie, strong CYP3A4 inhibitors: grapefruit juice or grapefruit/grapefruit related citrus fruits [eg, Seville oranges, pomelos], ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan; moderate CYP3A4 inhibitors: erythromycin, verapamil, atazanavir, delavirdine, fluconazole, darunavir, diltiazem, aprepitant, imatinib, tofisopam, ciprofloxacin, cimetidine); for participants in the dose escalation portion, no CYP3A4 inhibitors should be administered during the first 21 days of the study, regardless of strength
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
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 receiving any medications or substances that are moderate to strong inhibitors CYP1A2 are ineligible
Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks
Concomitant use of CYP3A4 inhibitors
Subjects who are required to use a medication classified as a strong CYP3A inducer of inhibitor
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 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
Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible; these include herbal preparation containing CYP3A4 inducers (e.g., St. John’s wort), grapefruit and grapefruit juice (CYP3A4 inhibitor) within 2 weeks before the start of study treatment; 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
Strong CYP3A4 inhibitors
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
Subjects who are receiving strong CYP3A4 inhibitors or CYP3A4 inducers
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)
Receiving medications that are strong inhibitors or inducers of CYP3A4 (Appendix D).
Concurrent use of any medications or substances; these include steroids as they may interfere with PF-04518600 (OX40 Ab); also strong CYP3A4/5 inhibitors should be avoided (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole)
Currently receiving any known strong inducers or inhibitors of CYP3A4/5 which cannot be discontinued 7 days prior to starting study drug
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 CYP3A4/5\r\n* Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, and/or CYP2C9\r\n* Therapeutic doses of warfarin sodium (Coumadin) or any other coumadin-­derived anti­coagulant\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, 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
Participant has received strong or moderate CYP3A inducers 7 days prior to the initiation of study treatment.
Chinese participants are excluded from receiving strong and/or moderate CYP3A inhibitors 7 days prior to the initiation of study treatment through the end of intensive PK collection (24 hours post dose on Cycle 1 Day 10).
Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil); the required washout period prior to starting olaparib is 2 weeks; during the study, if co-administration of a strong or moderate inhibitor is required, exception to this criterion may be allowed with a suitable dose reduction of olaparib
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
Receiving, or received, concomitant medications, herbal supplements and/or foods that significantly modulate CYP3A4 inhibitors or moderate CYP3A inhibitors, strong CYP3A inducers or moderate CYP3A inducers
Participants must not be on medications, including antiretroviral (ARV) regimens such as cobicistat, indinavir, or ritonavir, or agents with moderate or strong CYP3A4 inhibition; if on a moderate or strong CYP3A4 inhibitor regimen prior to study enrollment, participants must be switched to a qualifying regimen with the last dose of the strong CYP3A4 inhibitor taken at least one week before administration of ibrutinib
No strong inducers of CYP3A4 (see Appendix 13.5) within 2 weeks prior to first study treatment.
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
Use of strong or moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4, including certain herbal medications (eg, St. John's Wort) and consumption of grapefruit or grapefruit juice within 14 days or 5 x the half?life (whichever is longer) prior to the first dose of study drug.
Is currently using (i.e., within 14-days prior to first dose) drugs that are known strong CYP3A4/5 inhibitors / inducers.
Currently receiving treatment, including medications and herbal preparations with known strong inducers or inhibitors of cytochrome p450 enzymes cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) medications that have a narrow therapeutic window and are predominately metabolized through CYP3A4/5 or herbal preparations/medications, dietary supplements, which cannot be discontinued at least one week prior to receiving investigational drug; anti-retrovirals, anti-microbials, and anti-arrhythmics are the most common medications that interact with these enzymes
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
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
Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible
Concomitant use or use in the prior two weeks of moderate or strong CYP3A and CYP2C9 inducers or strong CYP2C9 inhibitors, including nutraceutical preparations, e.g., grapefruit juice and St John’s wort
Currently receiving any of the following that cannot be discontinued at least 7 days prior to starting study drug:\r\n* Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\r\n* Medications with a narrow therapeutic window that are predominantly metabolized through CYP3A4/5\r\n* Herbal supplements, such as St. John’s wort; the use of marijuana or its derivatives is allowed in States with statutes permitting the use of recreational or medical marijuana
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
Received the following agents within 7 days prior to the first dose of venetoclax:\r\n* Strong and moderate CYP3A inhibitors\r\n* Strong and moderate CYP3A inducers\r\n* Consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug:\r\n* Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\r\n* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\r\n* Herbal preparations/medications, dietary supplements
Patients currently receiving treatment with strong CYP3A4 inhibitors and treatment cannot be either discontinued or switched to a different medication prior to starting study drug
Patients actively receiving therapy with herbal medicines that are strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to study entry; these herbal medicines may include Echinacea (including Echinacea [E.] purpurea, E. angustifolia and E. pallida), Piperine, Artemisinin, St. John’s Wort, and Ginkgo
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.
Concomitant use of a strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, ketoconazole, voriconazole, nefazodone, posaconazole, ritonavir, lopinavir/ritonavir, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) and moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole. Fosamprenavir, imatinib, verapamil)
Requires treatment with a strong CYP3A4 inhibitor/inducer
Patients receiving any medications or substances that are potent inhibitors or inducers of CYP1A2 or CYP2D6 are ineligible
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitors or inducer
Patients receiving any medications or substances that are strong inhibitors or inducers of CYP1A2 and/or CYP3A4 are ineligible
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor/inducers
Medical need for the continued use of potent inhibitors/inducers of CYP3A4
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
Concurrent administration of strong inducers and inhibitors of CYP3A enzyme or CYP3A substrates with narrow therapeutic window
Require treatment with strong cytochrome P450 family 3 subfamily A (CYP3A) inhibitors
Concomitant use of CYP3A4 inhibitors
Strong inhibitors or inducers of hepatic microsomal isoenzymes
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
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)
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
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
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
Current use or anticipated inability to avoid use of drugs that are known strong cytochrome P450 family 3 subfamily A member 4/5 (CYP3A4/5) inhibitors (atazanavir, boceprevir, conivaptan, clarithromycin, grapefruit or grapefruit juice, indinavir, itraconazole, ketoconazole, nelfinavir, nefazodone, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole)
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
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
Concomitant use of known strong cytochrome P450 (CYP) 3A (CYP3A) inhibitors or moderate CYP3A inhibitors. Concomitant use of known strong or moderate CYP3A inducers.
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
The use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors, including: itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice (or grapefruits)\r\n* Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
Patients receiving any medications or substances that are moderate or strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) 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
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
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
Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
Concomitant use of strong CYP3A4, CYP1A2, or CYP2C9 substrates
Taking a strong inhibitor or inducer of cytochrome P450; intermediate inhibitors are allowed if deemed medically necessary
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
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)
Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4)
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.
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
Requires treatment with a strong cytochrome P450 modulators (cytochrome P450, family 3, subfamily A [CYP3A] inhibitor and/or CYP3A inducers)
Concomitant use of medications that are known cytochrome p450 family 3 subfamily A member 4 (CYP3A4) substrates
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
Strong inducers of cytochrome P450 3A4 (CYP3A4) are not permitted starting day -14 of cycle 1
Requires treatment with a strong cytochrome P450 (CYP), family 3, subfamily A (3A) inhibitor
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
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
Patient who are required to take a strong CYP3A4 inducer are excluded from the study
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)
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug\r\n* Known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\r\n* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\r\n* Herbal preparations/medications, dietary supplements
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)
CERITINIB EXCLUSION CRITERIA: 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 known risk of prolonging the QT interval or inducing torsades de pointes\r\n* Strong inhibitors or strong inducers of CYP3A4/5\r\n* Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, and/or CYP2C9\r\n* Therapeutic doses of warfarin sodium (coumadin) or any other coumadin-derived anticoagulant; 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
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
Unable or unwilling to discontinue use of any sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic window
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
PHASE I: Concomitant use of known potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Strong inducers or inhibitors of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John?s Wort).
Patients receiving any medications or substances that are inhibitors or inducers of nonsteroidal anti-inflammatory drugs (NSAIDS), probenecid, salicylates, sulfonamides are ineligible; concomitant drugs that are sensitive CYP450 substrates or strong and moderate CYP450 inducers and inhibitors should be avoided; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients receiving concomitant treatment with strong cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inhibitors, unless such drugs are considered critical for the well being of the patient and not adequate alternatives are available; strong CYP3A4 inhibitors include the following medications: itraconazole, ketoconazole, miconazole, voriconazole; amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir; ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, isoniazid, ketamine, nefazodone, nicardipine, propofol, quinidine, telithromycin
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
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)
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.
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
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
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors where the interaction is thought too great to proceed with romidepsin
Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
Strong inducers of CYP3A4
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 medications\r\n* Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible\r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\r\n* CYP3A4 agents: 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\r\n* CYP2C19 agents: patients who are currently receiving drugs that are strong CYP2C19 inducers (e.g., rifampin, ritonavir) or inhibitors (e.g.., fluoxetine, fluvoxamine, ticlopidine) are not eligible
Use of CYP3A4 inhibitors or inducers and CYP2D6 substrates must be discontinued prior to study entry
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
Any concomitant potent inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
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 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
Subject takes cytochrome P450, family 3, subfamily A (CYP3A) inhibitors/inducers within 7 days prior to the study drug administration
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
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
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
Requires treatment with a strong cytochrome P450 (CYP) family 3, subfamily A (3A) inhibitor
Patients requiring strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Concurrent administration of strong inhibitors or moderate inducers of CYP1A2 is not permitted; administration must be discontinued at least 7 days prior to initiating study drug administration.
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
Receiving drugs known to be strong inducers or inhibitors of permeability (P)-glycoprotein that are known to interact with afatinib including, but not limited to: ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the subject must stop the strong inducer or inhibitor of P-glycoprotein 7 days before or 5 half lives before study drug administration (whichever timepoint is longer)
Planned ongoing administration of STRONG cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
On medications which are CYP3A inhibitors.
Patients receiving any medications or substances that are strong inducers/inhibitors or substrates of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5, cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), CYP2C8, or CYP2C19 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
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.
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
Is receiving concomitant treatment with a strong inhibitor or inducer of CYP3A4/5.
Concomitant use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
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
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
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
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
Use of moderate to strong CYP3A4 inhibitors within 2 weeks prior to start 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
Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug; (please note that co-treatment with weak inhibitors of CYP3A is allowed)
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
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
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
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
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)
**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.
Relapsed/refractory MCL: Requires treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) inhibitors
Newly diagnosed MCL: Requires treatment with strong CYP3A4/5 inhibitors
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
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 who require medications that are strong CYP3A4 inhibitors or inducers
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 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
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
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
Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment
Participants taking a drug known to be strong inhibitors or inducers of isoenzyme CYP3A; participant must be off CYP3A inhibitors and inducers for at least 7 days prior to planned start of study treatment; NOTE: participants must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to planned start of study treatment and during the entire study treatment period due to potential CYP3A4 interaction
Received a potent CYP3A inhibitor within 7 days or potent CYP3A inducer within 5 weeks prior to first dose of AP32788.
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
Anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (i.e., verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine); grapefruit juice is also a CYP3A4 inhibitor
No concomitant medications such as phenytoin, carbamazepine, rifampicin, barbiturates, ketoconazole and itraconazole, which are potent inducers of CYP3A4 or potent inhibitors of CYP3A4
Administration of a strong or moderate CYP3A inhibitor or inducer =< 14 days prior to registration
concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein; Standard criteria:
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)
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
Receiving any medications or substances that are inducers of CYP3A4; use of inducers are prohibited =< 7 days prior to registration
Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug (Please note that co-treatment with weak inhibitors of CYP3A4 is allowed)
Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
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
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.
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
Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
Strong or moderate CYP3A inhibitors within 3 days prior to day 1 of protocol therapy
Strong or moderate CYP3A inducers within 7 days prior to day 1 of protocol therapy
Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil); the required washout period prior to starting olaparib is 2 weeks
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
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
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 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.
Current treatment with a combination of ibrutinib and strong CYP3A inhibitors
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
Strong inhibitors or inducers of cytochrome P450 3A (washout from prior use of such agents before C1D1 must exceed 21 days)
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
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
Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
Requires treatment with strong cytochrome P4503A (CYP3A) inhibitors.
Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzymes CYP3A or CYP2C8. The patient must have discontinued strong inducers for at least 1 week and must have discontinued strong inhibitors before the start of the study treatment. Switching to a different medication prior to initiation of the trial treatment is allowed.
Administration of strong CYP2C8 or CYP3A4 inhibitors or inducers =< 10 days prior to registration
Patient is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A; the patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment; switching to a different medication prior to randomization is allowed
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
Patients currently receiving treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors and treatment cannot be either discontinued or switched to a different medication prior to starting study drug
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
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 cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors is not allowed; patients must discontinue the drug >= 14 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
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
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
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
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
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or moderate inhibitors of CYP3A4 are ineligible; the study team should check a frequently-updated medical reference for a list of drugs to avoid or minimize use of; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Participants receiving any medications or substances that are potent inhibitors of CYP3A4, including grapefruit juice are ineligible; participants receiving fluconazole are also ineligible
Received strong cytochrome (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers and moderate CYP3A inducers within 7 days prior to initiation of study treatment
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
Received the following within 14 days prior to the initiation of study treatment: * Strong CYP2C8 inducers
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
Patients on drugs that are strong inhibitors and/or inducers of CYP2C9, CYP2C19 or CYP3A4 (including enzyme-inducing anti-epileptic drugs [EIAEDs]), are not eligible for treatment under this protocol; patients taking non-EIAEDs are permitted to take part in the study; patients previously treated with any of the prohibited concomitant medications listed above may be enrolled if they have been off of the medication for >= 10 days prior to the first dose of BAL101553
Required ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment; if such medications have been used, patients must have discontinued these agents at least 1 week prior to initiating study treatment; examples include:\r\n* Strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or strong CYP3A4 inducers;\r\n* Strong inhibitors of P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP);\r\n* Simvastatin and other hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (ie, statins)\r\n* Drugs that raise gastric potential of hydrogen (pH) including proton pump inhibitors and histamine-2 receptor antagonists (hydrogen [H2]-blockers); Note: Short-acting antacids, in place of proton pump inhibitors (PPIs) and H2-blockers, are permitted\r\n* HDAC inhibitors
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
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
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)
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
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
Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil); the required washout period prior to starting olaparib is 2 weeks
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
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
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
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
Concomitant use of strong and moderate CYP3A4 inhibitors and inducers
Less than 1 week since prior treatment (most recent dose) with a potent cytochrome P450 family 3, subtype A, polypeptide 4 (3A4) (CYP3A4) inhibitor
Concomitant use of potent P450 3A4 (CYP3A4) inducers
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
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
Concurrent use of medications or substances that are strong inhibitors of CY3A4 are ineligible
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 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 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
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
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates
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
Patients must not be taking, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 or CYP2D6 inhibitors and/or inducers
Patients must not be taking, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 or CYP2D6 substrates
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
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
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
Patient is being treated at start of study treatment with any of the following drugs:\r\n* Drugs known to be strong inhibitors or inducers of isoenzyme CYP3A4 including herbal medications \r\n* Drugs with a known risk to induce Torsades de Pointes \r\n* Note: the patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated; switching to a different medication prior to starting study treatment is allowed
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug:\r\n* Known strong inducers or inhibitors of cytochrome P450 family 3 subfamily A member 4/5 (CYP3A4/5), including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\r\n* That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\r\n* That have a known risk to prolong the QT interval or induce torsades de pointes\r\n* Herbal preparations/medications, dietary supplements not prescribed by a medical doctor (MD)
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)
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug (for details):\r\n* Known strong inducers or inhibitors of CYP3A4/5 including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\r\n* Those have a narrow therapeutic window and are predominantly metabolized through CYP3A4\r\n* Those have a known strong risk to prolong the QT interval or induce Torsades de Pointes\r\n* Herbal preparations
Subject is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme cytochrome P450, family 3, subfamily A (CYP3A); the subject must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment
Patients must NOT be taking current medications or substances that are inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4)
PHASE II: Patients must NOT be taking current medications or substances that are inhibitors or inducers of CYP3A4
Patients chronically receiving drugs that are known strong cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit, and grapefruit juice are not eligible
Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450, family 3, subfamily A (CYP3A); the patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment; switching to a different medication prior to starting study treatment is allowed
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
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
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
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
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 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
Patients on potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and inhibitors
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) (indinavir, nelfinavir, atazanavir, ritonavir, clarithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem); use of the aforementioned strong or moderate inhibitors is prohibited < 7 days prior to registration
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)
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
Patients taking medications known to be strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug
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
Subjects who require therapy with a strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor prior to enrollment to this study
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
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.
Patient is currently receiving any of the prohibited substances that cannot be discontinued 7 days prior to Cycle 1 Day 1: concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5; medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5; systemic corticosteroids ? 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment; concomitant medications with a known risk to prolong the QT interval and/or known to cause torsades de points that cannot be discontinued or replaced by safe alternative medication.
For Cohort A: Is currently receiving strong or moderate inhibitors of CYP3A4 including azole antifungals; macrolide antibiotics; or protease inhibitors
For Cohort A: Is currently receiving strong or moderate inducers of CYP3A4
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.
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.
Strong inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited; grapefruit juice is an inhibitor of CYP450 and should not be taken with pazopanib
Strong inducers of CYP3A4 are prohibited
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
Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the initiation of study treatment.
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
Patient cannot be taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors such as:\r\n* Antibiotics: clarithromycin, telithromycin, troleandomycin\r\n* Human immunodeficiency virus (HIV) antiviral protease inhibitors: ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir\r\n* Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole\r\n* Antidepressants: nefazodone
Requires treatment with a strong CYP3A inhibitor/inducer.
requires treatment with strong CYP3A inhibitors
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
Unable or unwilling to discontinue use of prohibited medications within 14 days prior to randomization and while on treatment:\r\n* No chronic treatment with systemic steroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed\r\n* Growth factors (e.g. granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [G-GM-CSF], erythropoietin, platelets growth factors etc.) are not to be administered prophylactically but may be prescribed by the treating physician for rescue from severe hematologic events\r\n* Live vaccines must not be administered to patient \r\n* Drugs known to be strong inhibitors or inducers of the isoenzyme cytochrome P450 family 3 subfamily A member 4 (CYP3A4) must not be administered as systemic therapy; drugs or substances known to be moderate inhibitors or inducers of CYP3A should be avoided if possible or used subject to caution; co-administration with strong or moderate inhibitors of P-glycoprotein (PgP) should be avoided if possible, or used subject to caution; concomitant use of Seville orange, star fruit, grapefruit and their juices should be avoided
Subject is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme cytochrome P450 family 3, subfamily A (CYP3A); the subject must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment
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
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
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)
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)
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)
Patients must not be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors, (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, ritonavir) and/or strong CYP3A4 inducers (e.g. phenytoin, rifampin, rifabutin) within 14 days prior to randomization (moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution)
Use of moderate/strong cytochrome P450 (CYP)3A4 inhibitors or moderate/strong CYP3A4 inducers within 2 weeks prior to the first dose of study drug (with the exception of enzalutamide in the combination arms)
Concomitant treatment with strong inhibitors or inducers of CYP3A4 and P-glycoprotein
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
Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
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.
Chronic treatment (i.e. >7 days) with a strong Cytochrome P450 (CYP3A) inhibitor which cannot be terminated prior to the first dose of ibrutinib.
Patient is currently receiving any of the following medications and cannot be discontinued =< 7 days prior to starting study drug: known strong inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges or that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5 or herbal preparations/medications or dietary supplements
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
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 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.
SUB-PROTOCOL AIM A: Receiving any concomitant antitumor therapy or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
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.
Requires treatment with strong CYP3A inhibitors
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
Treatment with medications that are known to be strong inhibitors or inducers of CYP450 enzymes.
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
Treatment with strong CYP3A4 inhibitors or inducers
Use of moderate/strong cytochrome P450 (CYP)3A4 inhibitors or moderate/strong CYP3A4 inducers within 2 weeks prior to the first dose of study drug
Participants taking medications that are known potent CYP3A4 inducers/inhibitors or substrates with narrow therapeutic indices or St. John's Wort.
Treatment with strong cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days before the first dose of study drug.
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.
Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pomelos, star-fruit, and Seville oranges
Strong CYP3A4/5 inducers or inhibitors
Sensitive CYP3A4/5 substrates or CYP3A4/5 substrates with narrow therapeutic index (NTI)
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.
Known strong inducers or inhibitors of CYP3A4/5,
Requires treatment with a strong cytochrome P450 (CYP) family 3, subfamily A, polypeptide 4/5 (3A4/5) inhibitor
Patients who require treatment with strong cytochrome P450 family 3, subfamily A (CYP3A) inducers
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
Patient is currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme cytochrome P450, family 3, subfamily A (CYP3A), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug; patients must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment; note: the oral anti-diabetic drugs troglitazone and pioglitazone are CYP3A inducers
Avoid the use of strong CYP3A/PgP inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole).
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).
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.
Use of strong CYP3A4 inducer
Concomitant use of CYP3A4 strong inducers and strong inhibitors
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
Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment
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
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)
Use of potent CYP3A4 inhibitors or inducers
Patients receiving potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) (such as but not limited to boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) inhibitors will be excluded from the study
Patients must not have continued requirement for therapy with a strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitor or inducer
Patients currently receiving treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors and treatment cannot be either discontinued or switched to a different medication prior to starting study drug
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
Any medications which are strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers
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 treatment with moderate CYP3A4 inhibitors
Patients requiring a strong inhibitor or inducer of CYP3A4
Patients requiring medications that are strong inducers or strong inhibitors of CYP3A4
Patients who require the following treatments moderate to strong CYP3A4 inhibitors; any substrates of CYP3A4/5 with a narrow therapeutic index
Moderate to strong CYP3A4 inducers
Concomitant use of known strong or moderate CYP3A inhibitors
Concomitant use of known strong or moderate 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
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 CYP3A.
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.
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug:\r\n* Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges\r\n* Those having a narrow therapeutic window and are predominantly metabolized through CYP3A4/5\r\n* Those having a known risk to prolong the QT interval or induce Torsades de Pointes\r\n* Herbal preparations/medications
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
Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug: a. Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges. b. That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. c. Herbal preparations/medications, dietary supplements. d. Hormone replacement therapy, topical estrogens (including any intra-vaginal preparations), megestrol acetate and selective estrogen-receptor modulators (e.g. raloxifene).
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
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
Participants requiring any medications or substances that are strong inducers or inhibitors of CYP3A4 are ineligible; those who may discontinue these medications are eligible after a 7 day washout period; mild or moderate inducers or inhibitors of CYP3A4 are permitted but moderate inhibitors will require dose reduction of ibrutinib
Patient requires treatment with a strong or moderate cytochrome P450 (CYP) 3A4 inhibitors, and inducers, or drugs known to induce Torsades de Pointes and the treatment cannot be discontinued or switched to a different medication prior to starting study drug
Is receiving concomitant therapy with strong CYP3A4 or CYP2A6 inhibitors or inducers
Patients currently receiving treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and treatment that cannot be either discontinued or switched to a different medication prior to starting study drug; patients receiving any medications or substances that are strong inhibitors of CYP3A4; all azoles but fluconazole are discouraged to be used in patients requiring treatment with antifungal antibiotics; use of the following strong inhibitors is prohibited =< 7 days prior to registration\r\n* Strong inhibitors of CYP3A4/5; > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance\r\n** Boceprevir (Victrelis)\r\n** Clarithromycin (Biaxin, Biaxin XL)\r\n** Conivaptan (Vaprisol)\r\n** Indinavir (Crixivan)\r\n** Itraconazole (Sporanox)\r\n** Ketoconazole (Nizoral)\r\n** Lopinavir/Ritonavir (Kaletra)\r\n** Mibefradil\r\n** Nefazodone (Serzone)\r\n** Nelfinavir (Viracept)\r\n** Posaconazole (Noxafil)\r\n** Ritonavir (Novir, Kaletra)\r\n** Saquinivir (Fortovase, Invirase)\r\n** Telaprevir (Incivek)\r\n** Telithromycin (Ketek)\r\n** Voriconazole (Vfend)\r\n** Troleandomycin\r\n** Cobicistat\r\n** Tipranavir
Concomitant treatment with strong cytochrome P450 3A4/cytochrome P450 3A5 (CYP3A4/5) inhibitor
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
Finasteroid (propecia), efavirenz, red clover, ketoconazole and other drugs that are cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
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
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
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
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) isoenzymes are ineligible
Received potent cytochrome P450 3A4 (CYP3A4) inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of study treatment
Able to stop all cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (voriconazole or posaconazole) at least 7 days before admission
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
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)
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
Use of potent cytochrome P450 3A4 (CYP3A4) inducer within one week of pacritinib initiation
Requires treatment with strong cytochrome P450 3A (CYP3A) inhibitors
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
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
Use of any medication or substances that are strong inhibitors or inducers of CYP3A isoenzymes.
Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4.
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.
Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450, family 3, subfamily A (CYP3A); the patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the start of treatment; switching to a different medication prior to the start of treatment is allowed
Current use of a prohibited medication; these include:\r\n* Patients who are receiving treatment with medications that are known to be strong inducers or inhibitors of CYP3A4/5 and CYP3A4/5 substrates with QT prolongation risk that cannot be discontinued prior to study entry\r\n* Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing torsades de pointes (TdP) and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment
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
Requires ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome 3A4 (CYP3A4) enzymes
Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug
Patients who are taking strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
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
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
Receiving any medications or substances that are inducers of CYP3A4; use of inducers are prohibited =< 7 days prior to registration
Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug
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
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)
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)
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)
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
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
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 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 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 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
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 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
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
Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to study enrollment; (please note that co-treatment with weak inhibitors of CYP3A is allowed)
Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) family 3, subfamily A (3A) inhibitor
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)
PHASE I: Participants receiving any medications or substances that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
PHASE II: Participants receiving any medications or substances that are strong inhibitors of 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
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)
Patients requiring strong CYP3A4 inducers or inhibitors are excluded
Use of cytochrome P450 isoenzyme 3A4 (CYP3A4)/ CYP2C19 substrates
Administration of medications or foods that are strong inhibitors or inducers of CYP3A within 2 weeks of randomization
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Requires treatment with strong CYP3A 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)
That are known strong inducers or inhibitors of CYP3A4.
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
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
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.
Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks
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
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
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
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
Receiving any medications or substances that are inducers of CYP3A4\r\n* Use of inducers is prohibited =< 12 days prior to 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 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)
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
HIV-positive patients requiring antivirals which are cytochrome P450 (CYP) interactive with the investigational agents (CYP3A4/5 strong inducers and inhibitors)
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)
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)
Requires treatment with strong CYP3A inhibitors
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
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 who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug (Please note that co-treatment with weak inhibitors of CYP3A is allowed)
Patients currently receiving treatment with strong CYP3A4 inhibitors and treatment that cannot be either discontinued or switched to a different medication prior to starting study drug; patients receiving any medications or substances that are strong or moderate inhibitors of CYP3A4\r\n* Use of the following strong or moderate inhibitors is prohibited =< 7 days prior to registration; concurrent use is not allowed simultaneously with nilotinib during the study\r\n** Strong inhibitors of CYP3A4/5 > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance\r\n*** Boceprevir (Victrelis)\r\n*** Clarithromycin (Biaxin, Biaxin XL)\r\n*** Conivaptan (Vaprisol)\r\n*** Grapefruit juice\r\n*** Indinavir (Crixivan)\r\n*** Itraconazole (Sporanox)\r\n*** Ketoconazole (Nizoral)\r\n*** Lopinavir/ritonavir (Kaletra)\r\n*** Mibefradil\r\n*** Nefazodone (Serzone)\r\n*** Nelfinavir (Viracept)\r\n*** Posaconazole (Noxafil)\r\n*** Ritonavir (Novir, Kaletra)\r\n*** Saquinivir (Fortovase, Invirase)\r\n*** Telaprevir (Incivek)\r\n*** Telithromycin (Ketek)\r\n*** Voriconazole (Vfend)\r\n** Moderate inhibitors of CYP3A4/5 > 2-fold in the plasma AUC values or 50-80% decrease in clearance\r\n*** Amprenavir (Agenerase)\r\n*** Aprepitant (Emend)\r\n*** Atazanavir (Reyataz)\r\n*** Ciprofloxacin (Cipro)\r\n*** Darunavir (Prezista)\r\n*** Diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)\r\n*** Erythromycin (Erythrocin, E.E.S. , Ery-Tab, Eryc, EryPed, PCE)\r\n*** Fluconazole (Diflucan)\r\n*** Fosamprenavir (Lexiva)\r\n*** Imatinib (Gleevec)\r\n*** Verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM)
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
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 receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) complex are ineligible
Patient must not be receiving any medication that is a strong cytochrome P450 3A4 (CYP3A4) inhibitor beginning 14 days prior to first dose of study drug; strong CYP3A4 inhibitors include (but are not limited to): antibiotics such as clarithromycin, telithromycin, troleandomycin; protease inhibitors such as ritonavir, indinavir, saquinavir, nelfinavir, lopinavir; antifungals such as itraconazole, ketoconazole, voriconazole; and antidepressants such as nefazodone
Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to study entry. See Appendix 14.1 for a list of these medications. This list may not be comprehensive.
Patients actively receiving therapy with herbal medicines that are strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to study entry. These herbal medicines may include Echinacea, (including E. purpurea, E. angustifolia and E. pallida), Piperine, Artemisinin, St. John's Wort, and Ginkgo.
Current systemic treatment with a potent cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor such as ketoconazole or ritonavir
Concomitant use of strong CYP3A4 inhibitors
Patients who require taking drugs that are strong inhibitors/inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) and cannot be switched to an alternative medication; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have received these medications within 1 week of entry
Patients taking substrates, inhibitors, or inducers of CYP3A4 should be encouraged to switch to alternative drugs whenever possible
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
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
Current use or anticipated need for food or drugs that are known strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine)
Receiving any medications or substances that are strong or moderate inhibitors of CYP3A4; use of the following strong or moderate inhibitors are prohibited =< 7 days prior to randomization:\r\n* Strong inhibitors of CYP3A4: indinavir (Crixivan), nelfinavir (Viracept), atazanavir (Reyataz), ritonavir (Norvir), clarithromycin (Biaxin, Biaxin XL), itraconazole (Sporanox), ketoconazole (Nizoral), nefazodone (Serzone), saquinavir (Fortovase, Invirase), telithromycin (Ketek)\r\n* Moderate inhibitors of CYP3A4: aprepitant (Emend), erythromycin (Erythrocin, E.E.S, Ery-Tab, Eryc, EryPed, PCE, fluconazole (Diflucan), grapefruit juice, verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM), diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)
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
Strong inhibitors or inducers of CYP3A4
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
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
Patients who are receiving treatment with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to study entry
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
Patients currently receiving treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and treatment cannot be either discontinued or switched to a different medication prior to starting study drug
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
Current use or anticipated inability to avoid use of drugs that are known potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, ergot derivatives, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine)
For ARMS A, C and D, unable or unwilling to discontinue use of any drug known to be a strong or moderate inhibitor or inducer of CYP3A4 (prohibited inducers must be discontinued within 2 weeks prior to first dose of study drug); please note that cotreatment with weak inhibitors of CYP3A4 is allowed
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
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
Treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors: \r\n* Cardiovascular: verapamil and diltiazem; \r\n* Antibiotics: clarithromycin, telithromycin, troleandomycin, erythromycin; \r\n* Human Immunodeficiency Virus (HIV): protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir); \r\n* Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole; \r\n* Antidepressants: nefazodone
EXPANSION COHORT ONLY: Treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors: \r\n* Cardiovascular: verapamil and diltiazem; \r\n* Antibiotics: clarithromycin, telithromycin, troleandomycin, erythromycin; \r\n* Human Immunodeficiency Virus (HIV): protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir); \r\n* Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole; \r\n* Antidepressants: nefazodone
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
Required treatment with certain strong CYP3A4 inhibitors or inducers.
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are ineligible
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.
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
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.
Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors;
Concomitant use of known strong or moderate CYP3A 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
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.
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
Participants who are taking strong CYP3A4 inhibitors
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
Requires treatment with strong cytochrome (CYP3A4/5) inhibitors
strong CYP3A4 inhibitors, or
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
Current (including their administration within 3 days prior to study entry) use or anticipated need for food or drugs that are strong CYP3A4 inhibitors.
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.
Strong or moderate CYP3A4 inhibitors or inducers
Strong or moderate P-gp inhibitors or inducers
Requires chronic treatment with strong cytochrome P450 (CYP)3A 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 treatment with strong CYP3A inhibitors at the time of study enrollment; for patients who can safely discontinue prior strong CYP3A inhibitor, a wash-out period of 5 effective half-lives is required prior to 1st dose of ibrutinib; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients 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
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
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.
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
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 have received potent cytochrome P450, family 3, subfamily A (CYP3A) inhibitors within 7 days prior to the initiation 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
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)
Cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) strong or moderate inhibitors/inducers in the past 7 days
Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug.
Ongoing or planned treatment with any of the following:\r\n* Atorvastatin\r\n* Strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4); 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** If any of these agents have been used, patients must be off them for >= 2 weeks before starting study treatment
Chronic concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole).
Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug; please note that co-treatment with weak inhibitors of CYP3A is allowed
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
Concomitant treatment with strong inhibitors or inducers of P-glycoprotein (P-gp)
Subject uses medication known to be strong inducers of CYP3A4 and CYP2C8 (Section 9.2).
No concurrent strong CYP3A4 inducers or inhibitors.
Concurrent use with strong inhibitors of CYP3A4 (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole)
Patients currently receiving treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors who cannot discontinue such treatment or be switched to a different medication prior to starting study drug are excluded from study entry; strong CYP3A4 inhibitors include the following medications: itraconazole, ketoconazole, miconazole, voriconazole; amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir; ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, isoniazid, ketamine, nefazodone, nicardipine, propofol, quinidine, telithromycin
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
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.
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
Concurrent use with strong inhibitors of CYP3A4 (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazadone, posaconazole, telithromycin, and voriconazole)
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
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.
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
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
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 who require concomitant treatment with CYP3A4/5 strong inhibitors or inducers OTHER than antiretroviral therapies for HIV\r\n* As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter product\r\n* A prednisone equivalent of < 20 mg daily is permitted in patients requiring chronic use; larger doses must be discontinued >= 7 days prior to ibrutinib initiation and are prohibited during study treatment
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
Subject requires either moderate or strong (if weak, 2 or more) inhibitors or inducers of Cytochrome P450 3A (CYP3A) mediated metabolism.
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.
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.
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
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
Use of strong/moderate CYP1A2 inhibitors.
No concurrent strong cytochrome P450 3A4 inhibitors
Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor).
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
Actual or potential cytochrome P450 (CYP) 3A interactions including: requirement for warfarin; use of strong and moderate CYP3A inhibitors or inducers within 7 days prior to first dose of venetoclax; or consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to first dose of venetoclax
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)
Strong CYP3A4 inducers and inhibitors should be avoided; selection of alternate concomitant medications with no or minimal CYP3A4 enzyme inhibition potential is recommended; 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
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
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
Treatment with medications that are known to be strong inhibitors or inducers of CYP450 enzymes
Use of strong cytochrome P450 3A4 (CYP3A4) inducer within 2 weeks prior to the first dose of MMB
Concurrent use of moderate to strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors is not allowed
Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1
The subject requires chronic concomitant treatment of strong CYP3A4 inhibitors
Patients receiving any medications or substances that are substrates of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) will be closely monitored for toxicity; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Requirement for 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.
Patients receiving any medications or substances that are strong inhibitors/inducers, sensitive substrates, or substrates with a narrow therapeutic index of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or permeability glycoprotein (P-gp) are ineligible; caution should be exercised when dosing dinaciclib and/or MK-2206 concurrently with CYP3A4 or P-gp substrates, inhibitors/inducers; if subjects are taken off a forbidden medicine, a one-week washout is required for inhibitors and two weeks for inducers; subjects on Coumadin are eligible but more frequent monitoring of the international normalized ratio (INR) (weekly during the first cycle, then at least each cycle thereafter) is recommended; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Use of 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 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.
Subject requiring concomitant use of strong CYP3A4 inhibitors or inducers.
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.
Use of potent cytochrome P450 family 3, subfamily A, polypeptide 4 (3A4) (CYP3A4) inhibitor within one week of pacritinib initiation
Contraindicated treatments noted in the product labelling for doxorubicin, including trastuzumab and inhibitors and inducers of CYP3A4, CYP2D6, or P-gp.
Strong inhibitors and potent inducers of CYP3A4
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor; strong inhibitors or inducers of CYP3A4/5 should be avoided and moderate inhibitors or inducers 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
Use of moderate or strong cytochrome P450 (CYP) 3A inhibitors or CYP3A inducers within 2 weeks before the first dose of study drug.
Narrow Therapeutic index substrates, strong inhibitors and strong inducers of CYP3A4
Patients who are concurrently receiving strong inducers/inhibitors of CYP3A
Systemic treatment with moderate and strong cytochrome P450 (CYP) CYP3A inhibitors or inducers must be discontinued at least 14 days before the first dose of MLN4924. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study. Participants must have no history of amiodarone use in the 6 months before the first dose of MLN4924.
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
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.
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
For two weeks prior to day 1 cycle 1, administration of specified cytochrome P450 3A (CYP3A) inducers
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.
Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before day 1 and during the study
Concomitant use of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Patient is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to randomization is allowed.
Patients taking cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors such as ketoconazole, ritonavir, itraconazole, erythromycin, clarithromycin, nelfinavir, fluconazole, amiodarone, cyclosporine, diltiazem, nefazodone, fluvoxamine, verapamil, chloramphenicol, indinavir or saquinavir within 7 days of treatment
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.
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
Systemic treatment with strong and moderate inhibitors of CYP1A2, strong and moderate inhibitors of CYP3A, or clinically significant CYP3A inducers or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study drug
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
Treatment with CYP3A inducers within 14 days before the first dose of MLN4924
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
Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP450 3A4) are ineligible
Currently taking strong or moderate inhibitors/inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); Note: dinaciclib is a CYP3A4 substrate; patients should not take grapefruit/grapefruit juice or St. John's wort; use of strong or moderate CYP3A4 inhibitors is prohibited from < 7 days prior to registration; use of CYP3A4 inducers is prohibited from =< 7 days prior to registration
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
Current treatment with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug; (please note that co-treatment with weak inhibitors of CYP3A is allowed)
Receiving strong CYP3A4 inhibitors/ inducers.
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
Use of rifampin (strong cytochrome P450 family 2, subfamily C, polypeptide 8 [CYP2C8] inducer) within 14 days of study day 1
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)
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
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
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
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
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
Strong and moderate Cytochrome P450 3A (CYP3A) inhibitors (Part 1 Dose Determination);
Strong and moderate CYP3A inducers (Part 1 Dose Determination and Part 2 Cohort Expansion).
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
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
Receiving any medications or substances that are inducers or strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) =< 7 days prior to registration\r\n* Use of CYP3A4 inducers are prohibited =< 7 days prior to registration\r\n* Use of CYP3A4 strong or moderate inhibitors are prohibited =< 7 days prior to registration
Received a strong or listed moderate inhibitor of CYP3A4 <2 weeks prior to first study dose
Patients should not be taking concomitant medication that are cytochrome P450 3A4 (CYP3A4) inducers or potent inhibitors (+++) and should try to avoid taking proton pump inhibitors and histamine (H2) antagonists during rest of treatment period; the above medications will be continued only if medically necessary and their use will be noted
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)
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
Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme cytochrome P450 family 3, subfamily A (CYP3A), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug
Patient is currently being treated with olanzapine and/or other drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug
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.
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 receiving any medications or substances that are inhibitors or inducers of cytochrome P450 (CYP450) enzyme(s) are ineligible
patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and treatments cannot be stopped or changed to a different medication at least 14 days prior to starting study drug
Patients may not be receiving agents thought to inhibit or induce the cytochrome p450 isoenzyme cytochrome P450 3A4 (CYP3A4)
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)
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
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
Use of strong and moderate CYP3A inhibitors and inducers =< 7 days prior to registration
Patient is currently receiving any of the prohibited substances that cannot be discontinued 7 days prior to Cycle 1 Day 1: concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5; medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5; systemic corticosteroids ? 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment; concomitant medications with a known risk to prolong the QT interval and/or known to cause torsades de points that cannot be discontinued or replaced by safe alternative medication.
Strong inhibitors or inducers of CYP3A4
Patients requiring chronic treatment with strong CYP3A inhibitors
Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs for > 2 weeks, and other platelet inhibitory agents, strong inhibitors/inducers of cytochrome P450-3A4 (CYP450-3A4)
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
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
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)
Subject who has received strong/moderate inhibitors or inducers of CYP3A4 within 14 days prior to the first dose 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 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
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
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 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 significant 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* 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* Enzyme-inducing anticonvulsive agents\r\n* Herbal supplements
Receiving any medications or substances that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5)
Receiving any medications or substances that are inducers of CYP3A4
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
Patient is being treated at start of study treatment with any of the following drugs:\r\n* Drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A4 including herbal medications\r\n* Drugs with a known risk to induce Torsades de Pointes\r\n* Note: The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated; switching to a different medication prior to starting study treatment is allowed
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
No concurrent use of moderate/strong CYP3A4 inhibitors, or strong 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 the following strong or moderate inhibitors are prohibited =< 7 days prior to registration\r\n* Strong inhibitors of CYP3A4:\r\n** > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance\r\n** Indinavir (Crixivan)\r\n** Nelfinavir (Viracept)\r\n** Atazanavir (Reyataz)\r\n** Ritonavir (Norvir)\r\n** Clarithromycin (Biaxin, Biaxin XL)\r\n** Itraconazole (Sporanox)\r\n** Ketoconazole (Nizoral)\r\n** Nefazodone (Serzone)\r\n** Saquinavir (Fortovase, Invirase)\r\n** Telithromycin (Ketek)\r\n* Moderate Inhibitors of CYP3A4\r\n** > 2-fold increase in the plasma AUC values or 50-80% decrease in clearance\r\n** Aprepitant (Emend)\r\n** Erythromycin (Erythrocin, E.E.S., Ery-Tab, Eryc, EryPed, PCE)\r\n** Fluconazole (Diflucan)\r\n** Grapefruit juice\r\n** Verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM)\r\n** Diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)
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
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 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.
Medications or supplements that are known to be moderate mechanism-based inhibitors or moderate inducers of CYP3A within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) 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 mechanism-based inhibitors or moderate CYP3A inducers based on the US FDA Draft DDI Guidance.
Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
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).
Clinical requirement for medications that are concurrent inducers or inhibitors of CYP3A4; CYP3A4 substrates are allowed
Prohibited medications: patients taking CYP3A4 enzyme inducers and moderate or strong inhibitors will be excluded from this trial
Co-administration of drugs that prolong QT interval, cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers, or other investigational agents (a wash-out period of five times the half life of drugs that prolong QT will be allowed with approval of prescriber)
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.
Concurrent administration of medications or foods that are moderate or strong inhibitors or inducers of CYP3A within 7 days prior to first dose of study drug
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
Requires treatment with a strong cytochrome P450 (CYP) family 3, subfamily A, polypeptide 4/5 (3A4/5) inhibitor
Use of strong CYP3A4 or CYP2C8 inhibitors or inducers or presence of any other contra indications for irinotecan
Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A)
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
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 taking any potent inhibitor of cytochrome P450 family 3, subfamily A, polypeptide 4 (3A4) (e.g., ketoconozole, itraconozole, erythromycin, etc)
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
Need for medications that are strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir), moderate CYP3A inhibitors (e.g. diltiazem, verapamil, erythromycin, fluconazole), CYP3A inducers (e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John’s wort), CYP3A substrates with a narrow therapeutic range (e.g. cyclosporine, tacrolimus, sirolimus), P-glycoprotein (P-gp) inhibitors or substrates (e.g. cyclosporine, digoxin), cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6) substrates (e.g. tricyclic antidepressants and antipsychotics),or simvastatin at doses > 20 mg/day within 7 days of the first planned ranolazine dose
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
Prior or current use of statin medication, or current use of gemfibrozil, cyclosporine, danazol, lomitapide, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, ranolazine, or strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, human immunodeficiency virus [HIV] protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, or cobicistat-containing products)
Patient requires treatment with strong CYP3A4 inhibitors or moderate or strong CYP3A4 inducers other than those required for GVH or infection prophylaxis or treatment
Use of any drugs or substances known to be strong or moderate inhibitors of CYP3A4 and CYP2D6 enzymes within 1 week prior to Day 1 or planned to be used during the overall study period.
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.
Use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4
Patients on strong CYP3A4 inducers or inhibitors that cannot be discontinued
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
Concomitant use of dual strong inhibitors or inducers (cytochrome P450, family 3, subfamily A, polypeptide 4 [CYP3A4], P-glycoprotein [P-gp])
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
Treatment with medications that are known to be strong inhibitors or inducers of CYP450 enzymes
Drugs with potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and inducers should be avoided during the course of treatment
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
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
Treatment with Strong inhibitors or inducers of CYP3A4 within 2 weeks prior to receiving study drug
Participants receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible
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
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
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
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).
Taking known strong cytochrome P450 (CYP) 2C8 inducers or 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
Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A
Requirement for medication with strong CYP3A4 inhibitor
Current use or anticipated need for food or drugs that are known strong or moderate CYP3A4 inhibitors, including their administration within 10 days prior to the first PF-06463922 dose (i.e., strong CYP3A4 inhibitors: grapefruit juice or grapefruit/grapefruit related citrus fruits [e.g., Seville oranges, pomelos], ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan; moderate CYP3A4 inhibitors: erythromycin, verapamil, atazanavir, delavirdine, fluconazole, darunavir, diltiazem, aprepitant, imatinib, tofisopam, ciprofloxacin, cimetidine)
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
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.
Use of concomitant medications that are known to be strong inhibitors or inducers of CYP3A4 enzyme unless participant can discontinue or switch medications.
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
Patients who are receiving strong CYP450 inducers or inhibitors are ineligible
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
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
Systemic treatment with moderate or strong CYP3A inhibitors or inducers must be discontinued at least 14 days before the first dose of alisertib, and the use of these agents is not permitted during the study (except for the protocol-specified administration of itraconazole).
Use of drugs or foods that are known strong CYP3A4 inhibitors, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice.
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.
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
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.
Medications or supplements that are known to be strong or moderate Cytochrome P4503A (CYP3A) inhibitors or strong or moderate CYP3A inducers and/or P-glycoprotein (P-gp) inhibitors or inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drugs. In general, the use of these agents is not permitted during the study except in cases in which an adverse event (AE) must be managed during interruption of study drug dosing.
Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. See Appendix 1 for a list of these medications. This list may not be exhaustive.
Patients actively receiving therapy with herbal medicines that are strong CYP3A4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. These herbal medicines may include Echinacea, (including E. purpurea, E. angustifolia and E. pallida), Piperine, Artemisinin, St. John's Wort, and Ginkgo.
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.
strong CYP3A inhibitors (including, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit, grapefruit juice)
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