Patients must not be receiving any strong CYP3A4 or P-glycoprotein (P-gp) inducers or inhibitors within 7 days prior to enrollment; moderate inducers or inhibitors of CYP3A4 and P-gp should also be avoided during ABI-009 treatment, if possible
Strong CYP1A2 inhibitors: Patients must not have received strong CYP1A2 inhibitors (ciprofloxacin, fluvoxamine, zafirlukast) for at least 7 days prior to enrollment and must not receive them for the duration of the study
Patients who have received drugs that are strong inducers of CYP3A4 within 14 days prior to study enrollment are not eligible; while on study, concomitant use of strong CYP3A4 inhibitors, BCRP inhibitors (cyclosporine, eltrombopag, gefitinib), and UGT1A1 inhibitors, (diclofenac, ketoconazole, probenecid, silibinin, nilotinib and atazanavir) should be avoided
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
No strong inducers of cytochrome P450 (CYP) 3A4 or CYP1A2 or strong inhibitors of CYP3A4 or CYP1A2 within 14 days prior to registration\r\n*Note: Ixazomib is a substrate of CYP3A4 and CYP1A2
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): No strong inducers of cytochrome P450 (CYP) 3A4 or CYP1A2 or strong inhibitors of CYP3A4 or CYP1A2\r\n* Note: Ixazomib is a substrate of CYP3A4 and CYP1A2
Patients should not require chronic use of strong CYP3A inhibitors or strong CYP3A inducers
Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study; Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
Patients who require chronic treatment with strong CYP3A4/5 inhibitors =< 14 days prior to registration are not eligible\r\n* NOTE: patients who are currently on treatment with strong CYP3A4/5 inhibitors may be eligible if they are able to be switched to an alternative therapy that is not a strong CYP3A4/5 inhibitor prior to registration on study
Receipt of strong CYP3A inhibitors or inducers (for treatment phase)
Concomitant use of strong inhibitors of CYP3A
Strong inhibitors (eg, ketoconazole) or inducers (eg, rifampicin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study)
Strong inhibitors and strong inducers of CYP3A4 should not be used concomitantly.
Use of strong CYP3A4 inhibitors or strong inducers within 7 days prior to the start of study treatment and for the duration of the study
Is receiving treatment with medication(s) that are known to be strong inhibitors or inducers of CYP3A4/5.
Ongoing treatment with CYP3A4 inducers or strong inhibitors.
Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have received these medications within 1 week prior to study entry; these include:
Participants receiving any medications or substances that are known to be strong inhibitors of CYP1A2, CYP2D6, and CYP3A4 or strong inducers of CYP3A4 are ineligible;
Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
Treatment with strong CYP3A inducers within 14 days prior to the first dose of study treatment of RO6870810/venetoclax.
Treatment with strong CYP3A4/5 inhibitors or inducers
known strong CYP3A inhibitors .
known strong CYP3A inducers
Concomitant medications:\r\n* Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study\r\n* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment\r\n* Patients requiring anticoagulation must be on stable dose of medication prior to registration
Participant requires treatment with concomitant drugs that are strong inducers of CYP3A within 14 days of start of study drug.
Participant requires treatment with concomitant drugs that are strong inducers of CYP3A within 14 days of starting study drug.
Currently using concomitant medications that are strong inhibitors or inducers of CYP3A4.
Drug interactions: Concomitant administration of strong CYP3A4/5 inhibitors or inducers is prohibited while on therapy; patients must not have received these medications for a minimum of 10 days prior to enrollment
Use of medications that are known to be strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
Part B1 only: No concomitant medications that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) or midazolam
Patients receiving concomitant treatment with strong CYP3A4 inhibitors within 3 days of start of study therapy (including posaconazole and voriconazole).
Requires chronic treatment with strong CYP3A inhibitors
Known intermediate or strong CYP3A4 or CYP2C8 inhibitors or inducers within 14 days prior to first dose of study treatment
STRATUM A: Participants who are receiving known strong inducers and/or strong inhibitors of CYP3A4/5, drugs that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5, and medications that carry a known risk for QT prolongation must discontinue these drugs at least 7 days prior to study enrollment
STRATUM B: Participants who are receiving known strong inducers and/or strong inhibitors of CYP3A4/5, drugs that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5, and medications that carry a known risk for QT prolongation must discontinue there drugs at least 7 days prior to study enrollment
STRATUM C: Participants who are receiving known strong inducers and/or strong inhibitors of CYP3A4/5, drugs that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5, and medications that carry a known risk for QT prolongation must discontinue there drugs at least 7 days prior to study enrollment
Patients receiving CYP3A substrates with narrow therapeutic indices, strong CYP3A inhibitors, and strong CYP3A inducers.
Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency
Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency.
Concomitant use of strong CYP3A4 inhibitors and inducers.
Has treatment with strong cytochrome P 3A (CYP3A) inducers within 14 days before the first dose of pevonedistat.
Participants who are receiving strong CYP3A4 inhibitors and inducers.
Current and concurrent use of strong CYP3A4 inhibitors or inducers.
Patients receiving medications that are strong CYP3A4 inhibitors or inducers are ineligible; concomitant use of strong CYP3A4 inhibitors with T-DM1 should be avoided; consider an alternate medication with no or minimal potential to inhibit CYP3A4
Patients taking strong CYP3A4 inhibitors or inducers with risk X (avoid combination) according to lexicomp
Received strong CYP3A inhibitors or strong CYP3A inducers within 7 days of starting venetoclax
Strong CYP3A4 inhibitors
Subjects who are receiving strong CYP3A4 inhibitors or CYP3A4 inducers
Receiving medications that are strong inhibitors or inducers of CYP3A4 (Appendix D).
No strong inducers of CYP3A4 (see Appendix 13.5) within 2 weeks prior to first study treatment.
Is currently using (i.e., within 14-days prior to first dose) drugs that are known strong CYP3A4/5 inhibitors / inducers.
Planned ongoing treatment with another drug that may potentially have adverse interactions with brentuximab vedotin; if such a drug has been used, it must be discontinued at least 1 week prior to initiating study treatment; examples of potential interactions include:\r\n* Coadministration of strong inhibitors of CYP3A4 (eg, ketoconazole, ritonavir, clarithromycin)\r\n* Coadministration of CYP3A4 inducers (eg, rifampin)\r\n* Concomitant treatment with strong inhibitors of P-glycoprotein (P-gp)
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with study drug and for the duration of participation:\r\n* Medication with a significant known risk of prolonging the QT interval or inducing Torsades de Pointes\r\n* Strong inhibitors or strong inducers of CYP3A4/5 \r\n* Herbal supplements
Requires treatment with strong cytochrome P450 3A (CYP3A) inhibitors
Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4)
Any foods/supplements that are strong inhibitors or inducers of CYP3A are prohibited at least 7 days prior to initiation of and during study treatment
Strong inducers of cytochrome P450 3A4 (CYP3A4) are not permitted starting day -14 of cycle 1
Treatment with strong CYP3A4 and CYP2C19 inhibitors and/or inducers must be discontinued at least 1 week before administration of the first dose of study drug
Concurrent therapy with drugs known to be strong inhibitors of cytochrome P450 1A2 (CYP1A2), cytochrome P450 2D6 (CYP2D6), and cytochrome P450 3A4 (CYP3A4), or strong inducers of CYP3A4
known to be strong inducers or inhibitors of CYP3A4/5 (for single agent part); known to be moderate to strong inducers or inhibitors of CYP3A4/5 (for combination part)
CAPMATINIB EXCLUSION CRITERIA: Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of capmatinib treatment and for the duration of the study:\r\n* Strong and moderate inhibitors of CYP3A4\r\n* Strong inducers of CYP3A4\r\n* Proton pump inhibitors (PPI)
Strong inducers or inhibitors of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John?s Wort).
Strong inducers of CYP3A4
Medications or supplements that are known to be strong CYP3A mechanism based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drug. In general, the use of these agents is not permitted during the study except for AE management.
Newly diagnosed MCL: Requires treatment with strong CYP3A4/5 inhibitors
Patients who require medications that are strong CYP3A4 inhibitors or inducers
Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment
REGISTRATION TO TREATMENT (STEP 1): Patients should not be receiving concomitant strong CYP3A4 inducers or inhibitors =< 7 days prior to registration
REGISTRATION TO TREATMENT (STEP 2): Patients should not be receiving concomitant strong CYP3A4 inducers or inhibitors =< 7 days prior to registration
Current treatment with a combination of ibrutinib and strong CYP3A inhibitors
Treatment with strong CYP3A inhibitors or inducers within 14 days before the first dose of study drug; strong CYP3A inhibitors/inducers are not permitted during the study, including nutraceutical preparations, e.g., grapefruit juice and St John’s wort; patients must have no prior history of amiodarone in the 6 months prior to the first dose of pevonedistat
Requires treatment with strong cytochrome P4503A (CYP3A) inhibitors.
Administration of strong CYP2C8 or CYP3A4 inhibitors or inducers =< 10 days prior to registration
Patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; Note: Dexamethasone for CNS tumors or metastases, on a stable dose, is allowed
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
Treatment with strong inhibitors or inducers of CYP3A are prohibited from 14 days prior to the first dose of tazemetostat to the end of the study
Patients must not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, strong CYP3A4 inhibitors and/or strong CYP3A4 inducers; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution
Strong inducers of CYP3A4 are prohibited
requires treatment with strong CYP3A inhibitors
Requires treatment with strong CYP3A inhibitors Exclusion Criteria for Phase 2 Sub-study Cohort:
Patients treated within the last 7 days prior to randomization and/or concurrent use of drugs known to be strong CYP3A4 inhibitors or inducers (see appendix 21.3)
Concomitant treatment with strong inhibitors or inducers of CYP3A4 and P-glycoprotein
Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
Patients taking strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) who cannot interrupt therapy from the time the C-13 consent is signed through 30 days after the last dose of study therapy.
Requires treatment with strong CYP3A inhibitors
Treatment with strong CYP3A4 inhibitors or inducers
Seizures Patients who are currently receiving enzyme inducing anti-epileptic drugs that are known strong inducers or inhibitors of CYP3A4/5 (EIAEDs). Patients with a history of seizures and maintained on an anti-epileptic drug that is not a strong inducers or inhibitor of CYP3A4/5 are eligible.
Strong CYP3A4/5 inducers or inhibitors
Known strong inducers or inhibitors of CYP3A4/5,
Concomitant use of CYP3A4 strong inducers and strong inhibitors
Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization (Part 2).
Concurrent use of any strong inducers or strong inhibitors of CYP3A4
Patients requiring medications that are strong inducers or strong inhibitors of CYP3A4
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 CYP3A.
The following concomitant medications are not allowed from 7 days prior to the first dose of study drug and during venetoclax administration: strong CYP3A4 inhibitors including but not limited to fluconazole, ketoconazole, and clarithromycin or strong CYP3A4 inducers included but not limited to rifampin, carbamazepine
Is receiving concomitant therapy with strong CYP3A4 or CYP2A6 inhibitors or inducers
Requires treatment with strong cytochrome P450 3A (CYP3A) inhibitors
Patient is taking a drug known to be a strong inhibitor or inducers of the isoenzyme cytochrome P450, family 3, subfamily A (CYP3A); participants must be off a strong CYP3A inhibitors and inducers for at least two weeks prior to starting the study drug
Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 2 weeks before the first dose of study drug (See Appendix F for list of excluded drugs)
Strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4), strong inhibitors of cytochrome P450 1A2 (CYP1A2), or CYP3A4 substrates with a narrow therapeutic range within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
Patients requiring strong CYP3A4 inducers or inhibitors are excluded
Administration of medications or foods that are strong inhibitors or inducers of CYP3A within 2 weeks of randomization
Requires treatment with strong CYP3A inhibitors
That are known strong inducers or inhibitors of CYP3A4.
Requires treatment with strong CYP3A inhibitors
Concomitant use of strong CYP3A4 inhibitors
Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have received these medications within 1 week of entry
Strong inhibitors or inducers of CYP3A4
Patients who are receiving treatment with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to study entry
Required treatment with certain strong CYP3A4 inhibitors or inducers.
Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 weeks before the date of randomisation.
Participants who are taking strong CYP3A4 inhibitors
Requires treatment with strong cytochrome (CYP3A4/5) inhibitors
strong CYP3A4 inhibitors, or
Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.
Patients who are taking medications that are strong inducers or inhibitors of CYP3A4
Subjects currently taking medications known to be strong CYP3A4 inhibitors.
Concomitant therapy with strong CYP3A4 inhibitors or inducers
Strong CYP3A4 inhibitors or inducers as well as inhibitors of breast cancer resistance protein (BCRP) within 14 days or 5 drug half-lives, whichever is longer, before start of study drug.
Patients who require strong CYP3A inducers at the time of study enrollment are excluded; for patients who can safely discontinue prior strong CYP3A inducers, a wash-out period of 5 effective half-lives is required prior to 1st dose of ibrutinib
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
Subjects taking or likely to take strong and moderate CYP2D6 inhibitors, strong CYP1A1 inhibitors, and/or CYP1A1/CYP1A2 sensitive substrates or with narrow therapeutic index. Subjects receiving oral BAY1143269 and IV docetaxel must not take or be likely to take strong CYP3A1 inhibitors
Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug.
No concurrent strong CYP3A4 inducers or inhibitors.
Receiving treatment with medications that are known strong inhibitors or inducers of CYP3A, and cannot be discontinued 7 days prior to the start of the treatment and during the course of the study.
The subject requires chronic concomitant treatment of strong CYP3A4 inhibitors
Requirement for treatment with any of the prohibited medications including strong CYP3A inhibitors, strong CYP3A inducers, CYP3A substrates with a narrow therapeutic index, and medications with strong risk of QT prolongation
Concurrent therapy with drugs known to be strong inhibitors of CYP1A2, CYP2D6, and CYP3A4, or strong inducers of CYP3A4
Requires treatment with strong CYP3A inhibitors.
Use of strong Cytochrome P450 3A4 (CYP3A4) inducers while on study medication
Currently receiving medications known to be strong inducers or inhibitors of CYP3A4 with a narrow therapeutic window. Strong inducers and inhibitors of CYP3A4 with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug.
Subject requiring concomitant use of strong CYP3A4 inhibitors or inducers.
Strong inhibitors and potent inducers of CYP3A4
Narrow Therapeutic index substrates, strong inhibitors and strong inducers of CYP3A4
Patients who are concurrently receiving strong inducers/inhibitors of CYP3A
Receiving strong CYP3A4 inhibitors/ inducers.
Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of treatment
Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment
Further, patients treated with medications that were known to be strong inhibitors or inducers of CYP3A4/5 that could not be discontinued at least a week prior to start of treatment with LDK378 and for the duration of the study were also excluded.
Strong inhibitors or inducers of CYP3A4
Patients requiring chronic treatment with strong CYP3A inhibitors
Medications or supplements that are known to be strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drug. The use of these agents is not permitted during the study. See a list of prohibited strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers based on the US FDA Draft DDI Guidance.
Use of strong CYP3A4 or CYP2C8 inhibitors or inducers or presence of any other contra indications for irinotecan
Patient requires treatment with strong CYP3A4 inhibitors or moderate or strong CYP3A4 inducers other than those required for GVH or infection prophylaxis or treatment
Patients on strong CYP3A4 inducers or inhibitors that cannot be discontinued
Subjects taking strong CYP3A4 and CYP2C19 inhibitors and/or inducers should be considered with caution; alternative treatments that are less likely to affect MLN0128 (TAK-228) metabolism, if available, should be considered; if a subject requires treatment with 1 or more of the strong CYP3A4 and CYP2C19 inhibitors and/or inducers, the study doctor should be consulted
Treatment with Strong inhibitors or inducers of CYP3A4 within 2 weeks prior to receiving study drug
Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A
Medications or supplements that are known to be strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days or within 5 times the inhibitor or inducer half-life (whichever is longer) before the first dose of study drug. In general, the use of these agents is not permitted during the study except in cases in which an AE must be managed during interruption of study drug dosing.
Medications or supplements that are known to be strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or P-gp inducers within 7 days, or within 5 times the inhibitor or inducer half-life (whichever is longer), before the first dose of study drug. The use of these agents is not permitted during the study.