[c09aa8]: / clusters / final9knumclusters / clust_415.txt

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No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined
Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or CYP3A4 inducers
Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study
Patients who have taken medications that are known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) within 28 days prior to registration are NOT eligible for participation
Of the five major cytochrome P450 (CYP) isoforms, 3A4 (BFC) may be involved in Phase I metabolism of PLX3397, with possibly cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) playing a minor role; until information regarding exposure toxicity and exposure-response relationships are available with PLX3397, concomitant strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and inducers are not permitted in the event they alter the systemic exposure to PLX3397; these include anticonvulsants, mycin antimicrobials, and antiretrovirals; some common examples include inhibitors such as erythromycin, fluoxetine, gemfibrozil, and inducers such as rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine; concomitant treatment is permitted if the medication is not expected to interfere with the evaluation of safety or efficacy of the study drug; during the study, if the use of any concomitant treatment becomes necessary (e.g., for treatment of an adverse event), the treatment must be recorded on the electronic case report form (eCRF), including the reason for treatment, generic name of the drug, dosage, route, and start and stop dates of administration; sirolimus undergoes extensive hepatic and intestinal metabolism via CYP3A4 and cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A5), as well as excretion by permeability (P)-glycoprotein; strong CYP3A inhibitors such as ketoconazole or grapefruit juice are not permitted; patients should be monitored for supratherapeutic toxic levels of sirolimus and PLX3397; as bone marrow suppression including anemia, neutropenia, and thrombocytopenia have been reported in patients receiving sirolimus monotherapy, these adverse effects may be exacerbated in combination with PLX3397 for which patients will be closely monitored
Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (3A4/5); (a one-week wash-out period is necessary for patients who are already on these treatments)
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers unless able to stop medication(s) prior to starting study treatment
EXCLUSION CRITERIA FOR REGISTRATION: Currently taking medications and herbal or dietary supplements that are strong cytochrome P450 (CYP) family 3, subfamily A, polypeptide 4 (3A4) inducers or inhibitors; a washout period of at least 5 days is required and must have been completed prior to the start of neratinib if the patient was taking any of these agents; if unavoidable, patients taking CYP3A4 inhibitors should be monitored closely
Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with INC280 and for the duration of the study:\r\n* Strong and moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)\r\n* Strong inducers of CYP3A4\r\n* Proton pump inhibitors (PPI)
Is chronically taking a strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A) inhibitor or inducer and cannot be switched to an alternative agent at least 7 days prior to idelalisib or ibrutinib initiation that in the opinion of investigator/treating physicians precludes utilization of either Ibrutinib or Idelalisib; caution is recommended for patients taking moderate inhibitors of CYP3A
Patients who are taking medications that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or phosphoglycolate phosphatase (PgP) and need to remain on these medications
As ibrutinib is extensively metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), and patients must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5
Patients who are receiving drugs that are strong inducers or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers unless able to stop medication(s) prior to starting study therapies
Current use or anticipated need for food or drugs that are known moderate/strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers, with the exception of azole antifungals, which are permitted
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers are not permitted
Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; investigator can change to a similar agent that is a non-CYP3A4 inhibitor/inducer with a washout period of 1 week
Patients receiving any medications or substances that are potent inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) isoenzymes within 7 days of randomization for list of CYP3A inhibitors and inducers
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
Requires chronic treatment with strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Use of strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers
Require treatment with strong cytochrome P450 family 3 subfamily A (CYP3A) inhibitors
Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) are prohibited
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Requires treatment with a strong cytochrome P450 modulators (cytochrome P450, family 3, subfamily A [CYP3A] inhibitor and/or CYP3A inducers)
Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Patients receiving any medications or substances that are strong inhibitors of cytochrome (CY)P450 family 3 subfamily A polypeptide 4 (3A4) isoenzyme
Patients who would be required to concurrently take ruxolitinib in conjunction with a strong cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and have a platelet count less than 100,000 are ineligible for the study
PHASE I: Concomitant use of known potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Administration of strong/potent cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib except for oral corticosteroids up to 20 mg of prednisone equivalent per day
Need for concurrent treatment with medications that strongly interact with everolimus (cytochrome P450 family 3 subfamily A member 4 [CYP3A4] inducers or inhibitors)
Subject takes cytochrome P450, family 3, subfamily A (CYP3A) inhibitors/inducers within 7 days prior to the study drug administration
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; strong inhibitors and inducers of UGT/PgP should be used with caution
Requires treatment with strong cytochrome P450, family 3, subfamily A (3A) (CYP3A) inhibitors
Patients requiring strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Inducers and Inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4): patients required to be on any CYP3A4/5 inhibitors or inducers will be excluded (with the exception of dexamethasone, but all efforts should be made to reduce the dose of dexamethasone); patients must discontinue drug at least 7 days prior to starting dasatinib
Planned ongoing administration of STRONG cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
Concomitant use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
Patients taking medications or herbal supplements that are known to be strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors within at least 14 days prior to registration are excluded
Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Use of a strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor less than 14 days prior to initiation of study treatment
Patients taking any medications or substances that are inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A)
Patients who are receiving treatment with medications known to be strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/5 or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting study treatment with sonidegib\r\n* Note: if patients can stop receiving these medications, strong CYP3A4/5 inhibitors should be discontinued at least 7 days prior to starting study treatment with sonidegib and strong CYP3A/5 inducers should be discontinued at least 2 weeks prior to starting study treatment with sonidegib
Relapsed/refractory MCL: Requires treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) inhibitors
Exclude persons who require ongoing administration of STRONG cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or STRONG CYP3A4 inducers and/or STRONG cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) inhibitors
Unable to discontinue use of potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors/inducers
Patients that are taking cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and/or inhibitors; if a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the protocol, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on protocol
Taking any medications or herbal supplements that are known to be strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) within at least 14 days before the first dose of ponatinib
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); use of the strong or moderate inhibitors are prohibited =< 7 days prior to registration
Chronic concomitant treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors is not allowed; patients must discontinue the drug >= 14 days prior to registration
Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
Concomitant medications:\r\n* Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098\r\n* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment for patients with NF2 mutation enrolled to GSK2256098
VX-970 is primarily metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); therefore, concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided
Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded
Requiring potent cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors
Patients on cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CPY450 3A4); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration:\r\n* Strong inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4): indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin\r\n* Moderate inhibitors of CYP3A4: aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP450 CYP2C8); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration\r\n* Strong or moderate inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8): gemfibrozil, trimethoprim
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP450 CYP2C9); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration\r\n* Strong or moderate inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9): fluconazole, amiodarone
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A) isoenzymes should be ineligible
Use of strong cytochrome P450 family 3 subfamily A member 4 (3A4) (CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the start of study treatment
Subjects must be willing and able to come off any proton pump inhibitor (PPI)/other strong cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inhibitors or inducers/simvastatin
Patients must NOT be taking current medications or substances that are inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4)
Subjects taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) and cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) inhibitors and/or inducers should be considered with caution; alternative treatments that are less likely to affect MLN0128 metabolism, if available, should be considered; if a subject requires treatment with 1 or more of the strong CYP3A4 and CYP2C19 inhibitors and/or inducers, the principal investigator should be consulted
Patients who are on concomitant medications that are STRONG inducers or inhibitors of the cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) enzyme should stop 2 weeks prior to first dose of dasatinib, if all other eligibility has been confirmed
Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded
Patients who are taking concomitant medications that in the investigator’s opinion are strong inducers of the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) enzymes and therefore likely to interact with the study agents, will not be eligible
Patient currently receiving any drugs considered to be strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors which cannot be discontinued or changed to an alternative drug prior to enrolling on the trial
Patients on potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and inhibitors
Co-administration with strong inhibitors of cytochrome P450, family 3, sub family A, polypeptide 4 (CYP3A4) (e.g., ketoconazole, itraconazole, ritonavir) or P-glycoprotein (PgP)
Patients taking medications known to be strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Subjects who require therapy with a strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor prior to enrollment to this study
Patients who are currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzymes cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP34A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8); the patient must have discontinued moderate and strong inducers of both enzymes for at least one week and must have discontinued strong and moderate inhibitors before the start of treatment; switching to a different medication prior to start of treatment is allowed
Use of a strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor less than 14 days prior to initiation of study treatment
Chronic concomitant treatment of strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or CYP3A4 inhibitors
Not receiving any medications or substances that are strong inhibitors of cytochrome P450 family 2, subfamily D, polypeptide 6 (CYP2D6)
Concomitant use with strong or moderate cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/P-glycoprotein (PgP) inhibitors and CYP3A4/PgP inducers
SUB-PROTOCOL AIM A: Receiving any concomitant antitumor therapy or inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Patients who require treatment with strong cytochrome P450 family 3, subfamily A (CYP3A) inducers
Requirement for chronic use of medications known to be strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) iso-enzymes; Note: if patients can stop receiving these medications, CYP3A4 inhibitors should be discontinued at least 7 days prior to starting treatment with G-202
Any medications which are strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers
Concurrent use of drugs that are known to be moderate or strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or inducers or drugs that are known to prolong the QT interval
Concomitant use of strong inhibitors of the cytochrome p450, family 3, subfamily a, polypeptide 4 (CYP3A4) isoenzyme is not permitted; must have wash-out period of 5 times the half-life of the compound before first dasatinib dose
Patients on strong cytochrome p450 family 3 superfamily A (CYP3A) inducers or inhibitors that are unable to be discontinued
Inability or unwillingness to abstain from taking any medications or herbal supplements that are moderate or strong inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) at least 1 week prior dosing with AZD1775 and while on study treatment
Patients who are currently receiving treatment (within 5 days prior to starting study drug) with agents that are known strong inducers or inhibitors of cytochrome P450, family 3, subfamily A polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A polypeptide 5 (5), or that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or moderate inhibitors of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
Patients requiring any medications or substances that are strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or clinically significant enzyme inducers of CYP3A4 are ineligible
Requires treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Requires treatment with strong cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) inhibitors
Taking any medications or herbal supplements that are known to be strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) =< 14 days prior to registration
Patients who are taking strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors, and/or CYP3A4 inducers
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); use of strong or moderate inhibitors are prohibited =< 7 days to registration
Foods or medications that are strong or moderate inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) taken within 1 week prior to study treatment and for the duration of the study
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) or drugs metabolized by cytochrome P450 family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 5 (5) or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A4/5 inducers for at least 2 weeks prior to starting treatment with LDE225; NOTE: patients who are already on or require initiation of azoles other than fluconazole will be excluded from the phase I dose escalation portion of the study
Women currently taking drugs which are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are not eligible
Use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers
PHASE I: Participants receiving any medications or substances that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A) isoenzymes are ineligible
Concurrent use with strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors/inducers is prohibited; moderate CYP3A4 inhibitors/inducers should be used with caution
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Concomitant use of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors at time of screening; if use of CYP3A4 inhibitors becomes medically necessary during study, they must be used with caution
Required, chronic, use of drugs that are strong inhibitors or inducers of cytochrome p450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Patients receiving any medications or substances that are strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) are ineligible
PART B: Ponatinib is a substrate for cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), concurrent use with potent CYP3A4/5 inhibitors or inducers should be undertaken with caution
Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)\r\n* Use of strong or moderate inhibitors is prohibited =< 7 days prior to registration
Patients may not be receiving concurrent therapy with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or strong inhibitors or inducers of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8); please note that concurrent use of trimethoprim, a component of Bactrim, is prohibited per protocol; patients who require pneumocystis carinii pneumonia (PCP) prophylaxis will need to switch to an alternative antibiotic (e.g. Mepron)
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible\r\n* For patients on intermediate inducers or inhibitors, attempts should be made to switch to an alternative agent or delay enrollment until treatment course with concomitant agent completed; if not possible, patient may be enrolled if it is felt to be in the patients best interest as decided by the investigator\r\n* Weak inhibitors of CYP3A or CYP2C8 should be used with caution and attempts made to limit their use or find alternative agents, if possible
At the time of registration, patients must not be receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8); patients must not be planning to use herbal remedies (e.g., St. John’s wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1)
Concurrent administration or received cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors within 2 weeks prior to the first day of study drug treatment
Patients unwilling or unable to refrain from use of moderate or strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A)
Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this trial; patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to the start of study treatment
Patients receiving any medications or substances that are strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; moderate inducers of CYP3A4 should be used with caution
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) complex are ineligible
Concomitant use of any drug which is a moderate or strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor or strong CYP3A4 inducer
Concurrent therapy with strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) due to concerning possible drug-drug interactions with abiraterone
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Individuals receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) enzyme(s) are eligible only if principal investigator approves subject enrollment prior to registration; participants who have received a medication or substance listed may be enrolled on study as long as they have discontinued its use at least 48 hours prior to registration
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450, family 3, sub family A polypeptide 4/5 (CYP3A4/5) or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with erismodegib; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with erismodegib
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A5) or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with sonidegib; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with sonidegib
Concomitant medications listed are prohibited; inhibitors or inducers of cytochrome P450, family 3, subfamily, polypeptide 4 (CYP3A4) not listed can be used with caution
Patients taking medications known to be strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Concomitant use of strong or moderate cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Participants receiving any medications or substances that are strong/intermediate inhibitors or inducers of cytochrome P450 (CYP450) cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) are ineligible
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
Patients requiring chronic treatment with strong cytochrome P450 family 3, subfamily A (CYP3A) inhibitors cannot be treated with ibrutinib but idelalisib would be an option
Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) are ineligible
Planned use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or CYP3A4 inducers while on study treatment unless deemed clinically necessary with no reasonable alternatives and with expressed permission from the principal investigator
Patients who are currently on or have used potent or moderate inhibitors or strong inducers cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or p-glycoprotein (PgP) inhibitors in the past 2 weeks
Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this trial; patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to the start of study treatment
Subjects have received potent cytochrome P450, family 3, subfamily A (CYP3A) inhibitors within 7 days prior to the initiation of study treatment
Cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) strong or moderate inhibitors/inducers in the past 7 days
Use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors within 2 weeks of starting study medication
Strong inducers and inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), and therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids is not allowed on the study
Systemic exposure to ketoconazole or other strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) isoenzyme inhibitors or inducers within 14 days prior to the start of study treatment; systemic exposure to aminodarone is not allowed within 1 year prior to the start of study treatment
Patients taking concomitant medications (chronically or within 1 week of study drug administration) which are strong inhibitors of hepatic metabolism via cytochrome P450 (P450)/cytochrome P450, family 3, subfamily A, polypeptide 4 (CY3PA4) isoenzyme will be excluded
Concurrent use of moderate to strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors is not allowed
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
Patients taking moderate/strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) or drugs metabolized by cytochrome P450 family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225
Concomitant use of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
Patients currently receiving strong or moderate cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers; patients should not begin study drugs until at least 72 hours after the last dose (or longer) of the inhibitor or inducer
Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of cytochrome P450 family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) or with drugs metabolized by cytochrome 450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome 450 family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow therapeutic index that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers should be discontinued for at least 14 days prior to starting treatment with LDE225
Taking any of the following agents:\r\n* Chronic treatment with systemic steroids or another immunosuppressive agent\r\n* Live vaccines \r\n* Drugs or substances known to be inhibitors or inducers of the isoenzyme cytochrome P450 family 3, subfamily A (CYP3A)
Receiving treatment with any potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors within 7 days of the first dose of study drug
Receiving any medications or substances that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5)
Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors
Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A)
Patient is taking a drug known to be a moderate and strong inhibitor or inducers of the P450 isoenzyme cytochrome P450, family 3, subfamily A (CYP3A); participants must be off P450/CYP3A inhibitors and inducers for at least two weeks prior to starting the study drug
Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
Patients who are receiving treatment with medications known to be strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) or drugs metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have a narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225; note that patients who require anti-fungal prophylaxis are preferred to be on fluconazole, and, patients taking voriconazole or posaconazole who must continue are excluded from the dose escalation phase of the study; once the maximum tolerated dose (MTD) is established, patients taking voriconazole or posaconazole will be allowed to enroll but at a dose adjustment to be determined before the expansion phase opens
Concurrent use of medications that are strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors within 14 days prior to registration for protocol therapy; NOTE: concurrent use of other CYP3A4 inhibitors may be allowed at the discretion of the treating physician or principal investigator
Concomitant use of dual strong inhibitors or inducers (cytochrome P450, family 3, subfamily A, polypeptide 4 [CYP3A4], P-glycoprotein [P-gp])
Drugs with potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and inducers should be avoided during the course of treatment
Patients who are taking medications that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or permeability (P)-glycoprotein (PgP) and need to remain on these medications
Required administration of concomitant moderate or strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) for 14 days prior to the first dose of study drug; prior amiodarone for up to 6 months prior to day 1 of study treatment