[c09aa8]: / clusters / 9knumclustersv2 / clust_2469.txt

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Subjects taking strong inhibitors and/or inducers of cytochrome P (CYP) A, CYPC or CYPC within week preceding the first dose of MLN (TAK-); if a subject requires treatment with strong inhibitors and/or inducers of CYPA, CYPC and/or CYPC, alternative treatment must be considered; if no alternative is available, one such medication may be allowed after discussing with the study principle investigator
NO treatment with strong inhibitors and/or inducers of cytochrome P (CYP) A, or CYPC within week preceding the first dose of study drug
Exposure to sensitive or narrow therapeutic range substrates of the drug metabolising enzymes CYPC, CYPC, CYPC or the drug transporters Pgp, BCRP, OATPB, OATPB, OCT and OCT within the appropriate wash-out period before the first dose of study treatment.
Concomitant treatment with strong inhibitors or inducers of CYPA, CYPC and CYPC.
Strong CYPA and CYPC inhibitors or inducers or CYPA substrate drugs with a narrow therapeutic range taken within days or drug half-lives before start of study drug.
Treatment with strong inhibitors and/or inducers of cytochrome P (CYP) A, CYPC or CYPC within days prior to study registration
Require continued treatment with a medication that is known to be a strong inhibitor of CYPC.
Treatment with any of the strong CYPC inducers within days before the first dose of TAK-
Treatment with gemfibrozil (strong CYPC inhibitor) within days before the first dose of TAK-
Medications that have a narrow therapeutic window and are predominantly metabolized through CYPC, CYPC, CYPC, or CYPA;
Treatment with strong inhibitors and/or inducers of CYPA, CYPC, or CYPC within days preceding the first dose of the study drugs.
Participant is currently taking a strong CYPC inhibitor (e.g. gemfibrozil [Lopid])
Mifepristone can both inhibit CYPA and induce CYPA; addition of mifepristone to a pre-existing drug regimen may cause a mild and temporary increase in plasma drug concentration of drugs with significant CYPA metabolism; medications that are strong inducers of CYPA such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's wort may decrease plasma mifepristone levels; strong CYPA inhibitor medications are expected to cause the largest increases in plasma mifepristone concentrations\r\n* Mifepristone may increase the plasma drug concentration of concomitant medications with metabolism mediated by CYPC/CYPC; drugs with the largest increases will be those whose metabolism is largely or solely mediated by CYPC/C and include: non-steroidal anti-inflammatory drugs (NSAIDs) and warfarin
Concomitant use of the strong CYPC inhibitors gemfibrozil or trimethoprim (Bactrim)
Concomitant receipt of the following sensitive CYP substrate medications that have a narrow therapeutic range (unless the participant can be transferred to other medications at least half-lives prior to the start of study treatment): paclitaxel and docetaxel (CYPC), phenytoin (CYPC), S-mephenytoin (CYPC), thioridazine (CYPD), theophylline, and tizanidine (CYPA)
Known intermediate or strong CYPA or CYPC inhibitors or inducers within days prior to first dose of study treatment
Concurrent therapy with strong inhibitors or inducers of CYPA or CYPC or with sensitive substrates of CYPA, CYPC or CYPC
Patients receiving medications that are known to be substrates of CYPC (including paclitaxel), CYPC, or CYPC or to be oral substrates of CYPA with narrow therapeutic window; subjects who have discontinued any of these medications must have a wash-out period of at least days or half-lives of the drug (whichever is longer) prior to the first dose of merestinib
Mifepristone can both inhibit CYPA and induce CYPA; addition of mifepristone to a pre-existing drug regimen may cause a mild and temporary increase in plasma drug concentration of drugs with significant CYPA metabolism; medications that are strong inducers of CYPA such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's wort may decrease plasma mifepristone levels; strong CYPA inhibitor medications are expected to cause the largest increases in plasma mifepristone concentrations\r\n* Mifepristone may increase the plasma drug concentration of concomitant medications with metabolism mediated by CYPC/CYPC; drugs with the largest increases will be those whose metabolism is largely or solely mediated by CYPC/C and include: non-steroidal anti-inflammatory drugs (NSAIDs) and warfarin
Trametinib may be an inhibitor of CYPC in vivo; caution should be exercised when dosing trametinib concurrently with medications with narrow therapeutic windows that are substrates of CYPC
Treatment with strong inhibitors and/or inducers of cytochrome P (CYP) A, CYPC or CYPC within week preceding the first dose of study drug
Concomitant use or use in the prior two weeks of moderate or strong CYPA and CYPC inducers or strong CYPC inhibitors, including nutraceutical preparations, e.g., grapefruit juice and St Johns wort
While not an exclusion criterion, unless clinically indicated, patients should avoid taking other additional non-study medications that may interfere with the study medications; in particular, patients should avoid medications that are known to strong inhibitor or inducers of hepatic microsomal isoenzymes CYPA, CYPC, CYPC, CYPC, CYPA/, UGTA, UGTA and transporters BCRP and P-gp
Treatment with strong inhibitors and/or inducers of cytochrome P (CYP) A, CYPC or CYPC within week preceding the first dose of study drug
Concomitant use of strong CYPA, CYPA, or CYPC substrates
Treatment with strong CYPA and CYPC inhibitors and/or inducers must be discontinued at least week before administration of the first dose of study drug
All CYPC inhibitors, inducers, and substrates should be discontinued >= days prior to registration; systemic treatment with CYPC inhibitors (anastrozole, montelukast, quercetin, trimethoprim, gemfibrozil, rosiglitazone, pioglitazone), inducers (carbamazepine, phenytoin, rifabutin, rifampin), or substrates (amiodarone, repaglinide, rosiglitazone, sorafenib, torsemide) should be discontinued >= days prior to registration
Current use of strong CYPA inhibitors such as ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, and clarithromycin are prohibited; NOTE: moderate inhibitors of CYPA should be used with caution; navitoclax is a moderate inhibitor of CYPC and a strong inhibitor of CYPC; caution should be exercised when dosing navitoclax concurrently with CYPC and CYPC substrates; common CYPC substrates include paclitaxel, statins and repaglinide; CYPC substrates include celecoxib, phenytoin and warfarin; when possible, investigators should switch to alternative medications or monitor the patients closely
Strong CYPC inhibitors or CYPC substrates
OATPB/ substrates Received the following within days prior to the initiation of study treatment: * Strong CYPC inducers
Strong CYPC inhibitors or CYPC substrates
Received the following within days prior to the initiation of study treatment: * Strong CYPC inducers
Patients on drugs that are strong inhibitors and/or inducers of CYPC, CYPC or CYPA (including enzyme-inducing anti-epileptic drugs [EIAEDs]), are not eligible for treatment under this protocol; patients taking non-EIAEDs are permitted to take part in the study; patients previously treated with any of the prohibited concomitant medications listed above may be enrolled if they have been off of the medication for >= days prior to the first dose of BAL
Current use or anticipated need for food or drugs that are known strong or moderate CYPA inhibitors, inducers and substrates; drugs that are CYPC substrates; drugs that are sensitive CYPB substrates; drugs that are strong CYPC inhibitors; drugs that are strong CYPC inhibitors; and drugs that are P-gp substrates.
Selected dual substrates of CYPA/ and CYPC
Patients that have been treated with strong cytochrome P, family , subfamily C, polypeptide (CYPC) inhibitors, CYPC inducers, within weeks of starting the trial treatment.
Patients requiring treatment with strong CYPC inhibitors Additional exclusion criteria for PDR/Everolimus
If a potential study patient is taking any of the medications in the categories described below, the investigator will assess and document the use of medications known or suspected to fall in the following medication categories:\r\n* Moderate/weak CYPA inducers such as efavirenz and oxcarbazepine\r\n* CYPC substrates such as thiazolidinediones (glitazones) and select statins (because of expected inhibition of the metabolism of CYPC substrates) by venetoclax\r\n* CYPC substrates such as tolbutamide (because of expected inhibition of the metabolism of CYPC substrates by venetoclax; it is recommended to exclude CYPC substrates with a narrow therapeutic index such as phenytoin
Exposure to sensitive or narrow therapeutic range substrates of the drug metabolizing enzymes CYPC, CYPC, CYPC, CYPD or the drug transporters Pgp (MDR), BCRP, OATPB, OATPB, OCT and OCT within the appropriate wash-out period (a minimum of x reported elimination half-life) before the first dose of study treatment
Use of cytochrome P isoenzyme A (CYPA)/ CYPC substrates
Subjects taking the following sensitive cytochrome P (CYP) substrate medications that have a narrow therapeutic range are excluded from the study unless they can be transferred to other medications within ? half-lives prior to dosing: paclitaxel (CYPC) warfarin, phenytoin (CYPC), S-mephenytoin (CYPC), thioridazine (CYPD), theophylline and tizanidine (CYPA).
Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's wort; these drugs induce cytochrome P A (CYPA) and may decrease levels of taxanes; fluorouracil (-FU) is a strong cytochrome P C (CYPC) inducer, and concomitant use with carvedilol, celecoxib, fosphenytoin, fluoxetine, phenytoin, warfarin and other CYPC substrates should be used with caution
Certain medications that act through the cytochrome P (CYP) system are specifically prohibited in subjects receiving pazopanib and others should be avoided or administered with extreme caution and require principal investigator (PI) approval\r\n* Strong inhibitors of CYPA such as ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole may increase pazopanib concentrations and are prohibited; grapefruit juice is also an inhibitor of CYP and should not be taken with pazopanib\r\n* Strong inducers of CYPA, such as rifampin, may decrease pazopanib concentrations, are prohibited\r\n* Medications which have narrow therapeutic windows and are substrates of CYPA, CYPD, or CYPC should be avoided and, if necessary, administered with caution\r\n* Pazopanib, mg once daily, has no effect on CYPC, CYPA, or CYPC in vivo but does in vitro; therefore, therapeutic doses of warfarin, a substrate of CYPC, and omeprazole, a substrate of CYPC are permitted; caffeine, a substrate of CYPA, is also permitted
Use of prohibited medications (strong CYPA or CYPC inducers or inhibitors, or moderate CYPC inhibitor trimethoprim) within elimination half-lives of the inducer or inhibitor prior to first dose of the study treatment
Subject uses medication known to be strong inducers of CYPA and CYPC (Section .).
Substrates of cytochrome P, family , subfamily A, polypeptide (CYPA) or cytochrome P, family , subfamily C, polypeptide (CYPC)\r\n* Preliminary results of a clinical drug-drug interaction study, examining the effect of ganetespib on the pharmacokinetics of the CYPC-sensitive probe omeprazole, show a modest (%) increase in omeprazole exposure when coadministered with ganetespib; in vitro data implies expectation of greater interaction with CYPC substrates than with CYPA substrates; caution is advised when sensitive narrow therapeutic range CYPA or CYPC substrates are concomitantly administered
Receiving treatment with medications that are known CYPA, CYPA, CYPC, CYPC or CYPC substrates with narrow therapeutic index, and cannot be discontinued during the course of the study.
Prohibited medications, supplements and herbal medications:\r\n* Tetracycline and its derivatives (enhance the risk of retinoic acid toxicity)\r\n* Live vaccines\r\n* Vitamin A\r\n* St. Johns wort\r\n* Dong quai: Herbal supplement, (Angelica sinensis)\r\n* Cytochrome P family subfamily C member (CYPC) inhibitors: gemfibrozil, trimethoprim, thiazolinediones, montelukast, quercetin\r\n* CYPC inducers: rifampicin\r\n* Patients receiving any medications or substances that are moderate and strong inhibitors of CYPC or inducers of CYPC are ineligible and can only be enrolled if these medications are discontinued
Known poor metabolizers of CYPC substrates
Treatment with strong inhibitors and/or inducers of cytochrome P (CYP) A, CYPC or CYPC within week preceding the first dose of study drug
Subjects taking the following sensitive cytochrome P (CYP) substrate medications that have a narrow therapeutic range are excluded from the study unless they can be transferred to other medications prior to enrolling: paclitaxel (CYPC), warfarin, phenytoin (CYPC), S-mephenytoin (CYPC), thioridazine (CYPD), theophylline and tizanidine (CYPA)
Narrow therapeutic index substrates of CYPC, CYPC, CYPC and CYPD
Contraindicated: \r\n* CYPC sensitive substrates (unless close monitoring with labs or drug levels with dose adjustments is feasible), inducers, and moderate/strong inhibitors of CYPC; patients taking these concurrent medications are ineligible unless they can be switched to alternative medications prior to initiation of the study\r\n* CYPA/ inducers and moderate/strong inhibitors of CYPA/; patients taking these concurrent medications are ineligible unless they can be switched to alternative medications prior to initiation of the study
Crolibulin is a substrate of cytochrome P (CYP)C, CYPC, CYPC and CYPA; strong inducers and inhibitors of these enzymes will constitute concomitant medications that are prohibited during the study; these medications include but are not limited to: for CYPC, montelukast and trimethoprim, for CYPC, lovastatin and sertraline, for CYPC, fluoxetine, ketoconazole, pantoprazole, omeprazole, rabeprazole, and ticlopidine, for CYPA, itraconazole, clarithromycin, erythromycin, telithromycin, and verapamil
Treatment with strong inhibitors and/or inducers of cytochrome P (CYP) family A, CYPC or CYPC within week preceding the first dose of study drug
Current or anticipated need for drugs that are known cytochrome P isozyme CYPA or CYPC inducers or inhibitors; only exception is oral glucocorticoids, which are a required premedication for docetaxel
Currently receiving medications known to be strong inhibitors of CYPC, strong inducers (except enzalutamide) or inhibitors of CYPA and substrates of CYPA, CYPC and CYPC with a narrow therapeutic window. Strong inducers, inhibitors and substrates must be discontinued at least days prior to the first administration of study drug.
Use of strong CYPA or CYPC inhibitors or inducers or presence of any other contra indications for irinotecan
Subjects taking strong CYPA and CYPC inhibitors and/or inducers should be considered with caution; alternative treatments that are less likely to affect MLN (TAK-) metabolism, if available, should be considered; if a subject requires treatment with or more of the strong CYPA and CYPC inhibitors and/or inducers, the study doctor should be consulted
Need to use drugs that have a narrow therapeutic index and are substrates for CYPB, CYPC, CYPC, CYPC, OATPB, OATPB, and OCT (organic cation transporter ), ie warfarin, digoxin, phenytoin, paclitaxel, S-mephenytoin
Require treatment with inducers or inhibitors of cytochrome P (CYP)A, CYPC, CYPD, and CYPA within days before the first dose of study drug through the end of Period
Patients who are taking medications that may alter the metabolism of enzalutamide; this includes the following: strong or moderate CYPC inhibitors or inducers; strong CYPA inhibitors or inducers; or CYPC, C or A substrates with a narrow therapeutic index
Treatment with gemfibrozil (or other strong CYPC inhibitor) within days before the first dose of TAK-.