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
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
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
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
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
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
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
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
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
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
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
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)
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
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.
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
Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
Those have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
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
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).
That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.
Patients who are currently receiving treatment with agents that are metabolized predominantly through CYP3A4 and that have a narrow therapeutic window.
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.
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
Patients must not be receiving any of the following potent CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John’s wort
Co-administration with strong CYP3A4 inducers (e.g., phenytoin, rifampin, carbamazepine, St John’s Wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin), strong CYP3A4 inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, and voriconazole), and CYP3A4 substrates (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus and tacrolimus)
Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200 mg/day), voriconazole
The participant requires concomitant treatment with the following inhibitors of CYP3A4:\r\n* Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin\r\n* Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole, posaconazole\r\n* Antidepressants: nefazodone\r\n* Antidiuretic: conivaptan\r\n* Gastrointestinal (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); use of any of anti-retrovirals (delavirdine) or protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir, nelfinavir) is permitted; specifically, ritonavir and cobicistat is permitted for participants considered for the CYP3A4-inhibitor based ART regimen arm (Stratum A) of the trial; 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
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)
Current use of any of the following medications: boceprevir, carbamazepine, ciprofloxacin, cobicistat, conivaptan, enzalutamide, fluvoxamine, itraconazole, ketoconazole, mitotane, phenytoin, posaconazole, rifampin, ritonavir, St. John’s Wort, telaprevir, voriconazole, or zafirlukast
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.
Current use or anticipated inability to avoid use of drugs that are known strong CYP3A4/5 inhibitors (atazanavir, boceprevir, conivaptan, clarithromycin, grapefruit or grapefruit juice, indinavir, itraconazole, ketoconazole, nelfinavir, nefazodone, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole)
Concomitant medications, any of the following should be considered for exclusion: strong CYP3A4 inhibitors: (Patients must discontinue drug 7 days prior to starting ruxolitinib), including but not limited to boceprevir, clarithromycin, conivaptam, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole; in addition, patients will be instructed to avoid grapefruit or grapefruit juice, starfruit, or Seville oranges
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)
Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible; the subject requires concomitant treatment with the following inhibitors of CYP3A4:\r\n* Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin; specifically, clarithryomycin is permitted for patients considered for this trial\r\n* Antifungals: itraconzaole, ketoconazole, voriconazole, fluconazole, posaconazole\r\n* Antidepressants: nefazodone\r\n* Antidiuretic: conivaptan\r\n* Antiretrovirals: delaviridine or protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir, nelfinavir) or cobicistat-boosted antiretrovirals\r\n* Gastrointestinal (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)
The subject requires chronic concomitant treatment of strong cytochrome P450, family 3, subfamily A polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John’s Wort); the subject requires chronic concomitant treatment of strong CYP3A4 inhibitors (e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem, cimetidine, amiodarone, chloramphenicol, boceprevir, ciprofloxacin, delavirdine, diethyl-dithiocarbamate, fluvoxamine, gestodene, imatinib, mibefradil, mifepristone, norfloxacin, norfluoxetine, starfruit, telaprevir, voriconazole); 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 require chronic concomitant treatment of strong CYP450 3A4 inducers (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St. John’s wort) or inhibitors (eg. ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil and conivaptan)
Patients must stop taking ritonavir, idinavir, saquinavir, telithromycin, clarithromycin and nelfinavir 1 week prior to registration; Note: topical ketoconazole is permitted
Patients must stop taking phenytoin, rifampicin, rifapentine, rifabutin, carbamazepine, nevirapine, modafinil and St John’s wort (hypericum perforatum) 3 weeks prior to registration; patients must stop taking phenobarbitone 5 weeks prior to registration; patients must stop taking all strong CYP3A4 inhibitors, including clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir, prior to registration
Concomitant medications: the following medicines should be avoided on this study:\r\n* Inhibitors: ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir\r\n* Inducers: rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine\r\n* Patients receiving any of the above medications are ineligible
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)
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
Subjects taking the following are not eligible:\r\n* Carbamazepine (e.g., Tegretol)\r\n* Rifabutin (e.g., Mycobutin) or\r\n* Rifampin (e.g., Rifadin)\r\n* Rifapentine (e.g., Priftin)\r\n* St. John's wort\r\n* Clarithromycin (e.g., Biaxin)\r\n* Cyclosporine (e.g. Neoral or Sandimmune)\r\n* Diltiazem (e.g., Cardizem)\r\n* Erythromycin (e.g., Akne-Mycin, Ery-Tab)\r\n* Itraconazole (e.g., Sporanox)\r\n* Ketoconazole (e.g., Nizoral)\r\n* Telithromycin (e.g., Ketek)\r\n* Verapamil (e.g., Calan sustained release [SR], Isoptin, Verelan)\r\n* Voriconazole (e.g., VFEND)\r\n• Tacrolimus (e.g. Prograf)
Subjects taking fluconazole, voriconazole, itraconazole, posaconazole, and ketoconazole within 72 hours of study drug starting are not eligible; reinstitution of fluconazole, voriconazole, itraconazole, posaconazole, ketoconazole and diltiazem is permissible 72 hours after the last dose of sirolimus
Present use or anticipated need for cytochrome P450 (CYP) family 3, subfamily A, polypeptide 4 (3A4)-inhibiting, CYP3A4-inducing drugs (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole, rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St. John's wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin)
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
Caution should be exercised when administering paclitaxel (Taxol) concomitantly with medicines known to inhibit (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir and nelfinavir) OR induce (e.g. rifampicin, carbamazepine, phenytoin, efavirenz and nevirapine) either CYP2C8 or CYP3A4.
Concomitant use of known CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir.
Patients may not take any of the following medications while on study, but will be considered eligible if medication is discontinued 72 hours prior to first dose of sirolimus:\r\n* Carbamazepine (e.g. Tegretol)\r\n* Rifabutin (e.g. Mycobutin)\r\n* Rifampin (e.g. Rifadin)\r\n* Rifapentine (e.g. Priftin)\r\n* St. John’s wort\r\n* Clarithromycin (e.g. Biaxin)\r\n* Cyclosporine e.g. (Neoral or Sandimmune)\r\n* Diltiazem (e.g. Cardizem)\r\n* Erythromycin (e.g. Akne-Mycin, Ery-Tab)\r\n* Itraconazole (e.g. Sporanox)\r\n* Fluconazole (e.g. Diflucan)\r\n* Ketoconazole (e.g. Nizoral)\r\n* Telithromycin (e.g. Ketek)\r\n* Verapamil (e.g. Calan SR, Isoptin, Verelan)\r\n* Voriconazole (e.g. VFEND) - can take 72 hours after last dose of sirolimus\r\n* Tacrolimus (e.g. Prograf)
Subject is receiving potent inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); for such medications, a wash-out period of >= 7 days is required prior to starting dasatinib unless discontinuation or substitution of such an inhibitor is not in the best interest of the patient as determined by the investigator; these include the following medications: itraconazole, ketoconazole, miconazole, voriconazole; amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir; ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, isoniazid, ketamine, nefazodone, nicardipine, propofol, quinidine, telithromycin; in instances where use of these agents is felt to be required for the best management of the patients, inclusion of such a patients should be discussed with principal investigator (PI) and the rationale documented
Concomitant use of potent inhibitors of CYP 3A4 including ketoconazole, itraconazole and ritonavir. Consumption of grapefruit juice should also be avoided.
Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice; the topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed
Patients 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
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
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
Subject is taking ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin, rifampin, rifabutin, bromocriptione, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, protease inhibitors (e.g., human immunodeficiency virus [HIV] and hepatitis C that include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine, troleandomycin, verapamil, carbamazepine, phenobarbital, phenytoin, rifapentine, St. John’s wort (hypericum perforatum), and grapefruit juice; patients on metformin will not be excluded
Avoid the use of strong CYP3A/PgP inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole).
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 be receiving any of the following potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors: erythromycin, clarithromycin, azithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, grapefruit juice or St. John’s wort
The patient requires treatment with a medication that is a strong inhibitor of CYP3A4 (boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole).
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
Subjects taking the following are not eligible: \r\n* Carbamazepine (e.g., Tegretol) \r\n* Rifabutin (e.g., Mycobutin) or \r\n* Rifampin (e.g., Rifadin) \r\n* Rifapentine (e.g., Priftin) \r\n* St. John's wort \r\n* Clarithromycin (e.g., Biaxin) \r\n* Cyclosporine (e.g. Neoral or Sandimmune) \r\n* Diltiazem (e.g., Cardizem) \r\n* Erythromycin (e.g., Akne-Mycin, Ery-Tab) \r\n* Itraconazole (e.g., Sporanox) \r\n* Ketoconazole (e.g., Nizoral) \r\n* Telithromycin (e.g., Ketek) \r\n* Verapamil (e.g., Calan SR, Isoptin, Verelan) \r\n* Voriconazole (e.g., VFEND) \r\n* Tacrolimus (e.g. Prograf)\r\n* Subjects taking fluconazole, voriconazole, itraconazole, posaconazole, and ketoconazole within 72 hours of study entry are not eligible; reinstitution of fluconazole, voriconazole, itraconazole, posaconazole, ketoconazole and diltiazem is permissible 72 hours after the last dose of sirolimus
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)
Concurrent treatment with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice) or inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort)
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
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)
Patients must not be receiving any of the following potent CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John’s wort
Patients cannot have received cytochrome P450-inducing anticonvulsants (enzyme-inducing antiepileptic drugs [EIADs]; e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) or similar agents (e.g., rifampin) or P450 inhibiting agents (ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) within 10 days prior to starting lapatinib
Use of any strong CYP3A4 inhibitor such as ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir, or saquinavir (see Table 6 6) 14 days before the first dose of study drug or during the study
Chronic concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole).
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 use with strong inhibitors of CYP3A4 (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazadone, posaconazole, telithromycin, and voriconazole)
The following medications may not be taken within 24 hours of the first dose of study agent or at any time while a participant is taking study agent\r\n* Coumadin\r\n* Strong CYP3A4 inhibitors including ketoconazole, atazanavir, boceprevir, ceritinib, clarithromycin, cobicistat, darunavir, dasabuvir, idelalisib, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ombitasvir, paritaprevir, posaconazole, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice\r\n* CYP3A4 inducers including rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, primidone, enzalutamide, fosphenytoin, lumacaftor, mitotane, and St. John's wort\r\n* Agents which decrease gastric acid are allowed but should be avoided if possible\r\n* Participants may resume inhibitors or inducers of CYP3A4 > 14 days after their last dose of study agent
The participant requires concomitant treatment with the following inhibitors of CYP3A4:\r\n* Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin\r\n* Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole, posaconazole\r\n* Antidepressants: nefazodone\r\n* Antidiuretic: conivaptan\r\n* Gastrointestinal (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); use of any of anti-retrovirals (delavirdine) or protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir, nelfinavir) is permitted; specifically, ritonavir and cobicistat is permitted for participants considered for the CYP3A4-inhibitor based ART regimen arm (Stratum A) of the trial
Concurrent use of:\r\n* Strong CYP3A4 inhibitors: including but not limited to ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole\r\n* Strong CYP3A4 inducers: including but not limited to rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort\r\n* Therapeutic doses of anticoagulants (low dose warfarin up to 2 mg daily for DVT prophylaxis is permitted)\r\n* Grapefruit and grapefruit juice\r\n**(Note: Alternative therapies should be used when available; if use of a strong CYP3A4 inhibitor or inducer is necessary, this must be approved by the principal investigator and documented in source documents)
Patients must not be receiving any of the following potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's Wort
Use of ketoconazole, itraconazole, ritonavir, cyclosporine, carbamazepine, phenytoin, phenobarbital within 2 weeks prior to and while on study therapy
Use of the following strong inhibitors are prohibited =< 7 days prior to registration\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 (Norvir®)\r\n* Saquinavir (Invirase®)\r\n* Telaprevir (Incivek®)\r\n* Telithromycin (Ketek®)
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)
Use of any of the following medications within the past 6 months: clarithromycin, telithromycin, chloramphenicol, itraconazole, nefazodone, cobicistat
Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks (ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin)
The subject requires concomitant treatment with the following inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4):\r\n* Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin\r\n* Antifungals: itraconzaole, ketoconazole, voriconazole, fluconazole, posaconazole\r\n* Antidepressants: nefazodone\r\n* Antidiuretic: conivaptan\r\n* Anti-retrovirals: delaviridine or protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir, nelfinavir) or cobicistat-boosted antiretrovirals\r\n* Gastrointestinal (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
Use of potent CYP3A4 inhibitors, including but not limited to ketoconazole, atazanavir, clarithromycin, indinavir,\r\nitraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice
Use of potent CYP3A4 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice
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)
Current use of the following cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 3A4) inhibitors are not allowed: boceprevir, clarithromycin, cyclosporine (oral), darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, gemfibrozil, grapefruit juice > 1 liter per day, itraconazole, lopinavir plus ritonavir, nelfinavir, saquinavir plus ritonavir, telaprevir, tipranavir plus ritonavir
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.
strong CYP3A inhibitors (including, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit, grapefruit juice)
CYP3A4 Inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin many non-nucleoside reverse-transcriptase inhibitors (NNRTIs), diltiazem, verapamil, and grapefruit juice are not eligible
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
PIK3CA MUTANT AND WILD TYPE COHORT (closed 03/17/2016): 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) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John’s wort)
Anti-HIV agents: delavirdine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, lopinavir
Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors, including their administration within 10 days prior to patient treatment with study drug (eg, grapefruit juice or grapefruit/grapefruit-related citrus fruits [eg, Seville oranges, pomelos], ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, erythromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan); the topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed
Treated within the last 7 days prior to day 1 of protocol therapy with:\r\n* Food or drugs that are known to be CYP3A4 inhibitors (e.g. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, telithromycin, indinavir, ritonavir, nelfinavir, atazanavir, amprenavir, nefazodone, diltiazem, and delavirdine) or inducers (e.g. glucocorticoids, progesterone, rifampin, phenobarbital, St. John’s wort)\r\n* Drugs that are known to prolong the QT interval\r\n* Drugs that are proton pump inhibitors
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
Current or anticipated use of the following P gp inhibitors (amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, verapamil, and valspodar), P gp inducers (avasimibe, carbamazepine, phenytoin, rifampin, and St. John's wort), or BCRP inhibitors (curcumin, cyclosporine, elacridar [GF120918] and eltrombopag).
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)
Current use or anticipated need for food or drugs that are known strong 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) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John’s wort)
Concomitant medications \r\n* Corticosteroids: subjects 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\r\n* Investigational drugs: subjects who are currently receiving another investigational drug are not eligible\r\n* Anti-cancer agents: subjects who are currently receiving other anti-cancer agents are not eligible\r\n* Anti-graft-versus-host disease (GVHD) agents post-transplant: subjects 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* Study specific: subjects who are unable to swallow a tablet or swallow liquid are still eligible provided they have a nasogastric (NG) or gastric (G) tube through which the medicine can be administered\r\n* Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors: subjects chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, miconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed\r\n * CYP3A4 inducers: subjects chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, tipranavir, ritonavir, and St. John’s wort are not eligible
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
Drugs that potently inhibit or induce CYP3A4 should be administered with caution; below are a few examples of the agents:\r\n* Drugs that may increase exposure of trametinib (CYP3A4 inhibitors):\r\n** Antivirals: amprenavir, atazanavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir\r\n** Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin\r\n** Antifungals: fluconazole, itraconazole, ketoconazole, voriconazole\r\n** Antidepressants: nefazodone\r\n** Calcium channel blockers: mibefradil, diltiazem, verapamil\r\n** Miscellaneous: aprepitant\r\n* Drugs that may decrease exposure of trametinib (CYP3A4 inducers)\r\n** Antivirals: efavirenz, nevirapine\r\n** Antibiotic: rifampin\r\n** Anticonvulsants: carbamazepine, phenobarbital, phenytoin\r\n* Caution should be exercised when dosing trametinib concurrently with medications with narrow therapeutic windows that are substrates of CYP2C8; below are a few examples of the agents\r\n** Drug metabolism potentially affected by trametinib resulting in increased exposure of these substrates\r\n*** 3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA)-reductase inhibitors: cerivastatin\r\n*** Thiazolidinediones: rosiglitazone, pioglitazone\r\n*** Miscellaneous: chloroquine, zopiclone, repaglinide\r\n* As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, miconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed
Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to, ketoconazole, itraconazole, miconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed
Treated within the last 7 days prior to day 1 of protocol therapy with:\r\n* Food or drugs that are known to be CYP3A4 inhibitors (e.g. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, telithromycin, indinavir, ritonavir, nelfinavir, atazanavir, amprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John’s wort)\r\n* Drugs that are known to prolong the QT interval\r\n* Drugs that are proton pump inhibitors
Use caution when co-administered with moderate CYP3A4/PgP inhibitors (e.g., amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem).
Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, and delavirdine)
Patients cannot receive cytochrome P450 3A (CYP3A4) inhibiting drugs including antibiotics (clarithromycin, erythromycin, troleandomycin), anti-HIV agents (delavirdine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, lopinavir), antifungals (itraconazole, ketoconazole, fluconazole at doses > 200 mg/day, voriconazole), antidepressants (nefazodone, fluvoxamine), calcium channel blockers (verapamil, diltiazem) or amiodarone
Patients CANNOT be receiving enzyme-inducing or enzyme inhibiting agents listed here: Inhibitors: Amiodarone, Amprenavir, Atazanavir, Chloramphenicol, Clarithromycin, Conivaptan, Cyclosporine, Darunavir, Dasatinib, Delavirdine, Diltiazem, Erythromycin, Fluconazole, Fluoxetine, Fluvoxamine, Fosamprenavir, Imatinib, Indinavir, Isoniazid, Itraconazole, Ketoconazole, Lapatinib, Miconazole, Nefazodone, Nelfinavir, Posaconazole, Ritonavir, Quinupristin, Saquinavir, Tamoxifen, Telithromycin, Troleandomycin, Verapamil, Voriconazole; inducers: Aminoglutethimide, Bexarotene, Bosentan, Carbamazepine, Efavirenz, Fosphenytoin, Griseofulvin, Modafinil, Nafcillin, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Rifapentine, St. John’s wort, Sulfadimidine, Sulfinpyrazone, Troglitazone, Troleandomycin; all concomitant medications must be recorded
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)
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)
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
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
Patients receiving medications that may increase risk of rhabdomyolysis such as itraconazole, ketoconazole, erythromycin, cyclosporine, amiodarone, verapamil, clarithromycin, nefazodone, ranolazine, human immunodeficiency virus (HIV) protease inhibitors, gemfibrozil, posaconazole, danazol, amiodarone, diltiazem, and amlodipine
On scheduled strong or moderate CYP3A4 inhibitors (boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole; amprenavir, aprepitant, atazanavir, ciprofloxacin, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) within one week of study enrollment
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)
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
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
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
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.
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
Chronic use of known strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin, voriconazole, nefazodone, posaconazole, ritonavir, lopinavir/ritonavir, indinavir, saquinavir, boceprevir, telaprevir and nelfinavir), moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil), strong CYP3A4 inducers (e.g. phenytoin, rifampicin, carbamazepine, St. John’s wort, phenobarbital) and moderate CYP3A4 inducers (e.g. bosentan, efavirenz, etravirine, modafinil and nafcillin). Concomitant use of these drugs with olaparib is not allowed. Patients may undergo limited courses of them prior to starting olaparib but will be required to have >= 5-week washout period from phenobarbital, and >= 3-week washout period from the rest, before initiating treatment with olaparib.
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 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
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 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
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.
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 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