Concurrent use or receipt of a strong CYP3A4 inducer within 12 days prior to randomization or a strong CYP3A4 inhibitor within 7 days prior to randomization (see Table 10)
Patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration
Concomitant use of medications known to have strong inhibition or induction of CYP3A enzymes is discouraged and should be discussed with the study principal investigator (PI); note that systemic corticosteroids (e.g., dexamethasone is a CYP3A inducer) are not allowed; inhaled corticosteroids are allowed
Use of potent inhibitor or inducer of CYP3A4/3A5 within 14 days of planned study treatment or expected requirement for use of such a drug during study
Use of a potent inhibitor or inducer of drug transporters or conjugating enzymes within 14 days prior to planned study treatment or expected requirement for use of such a drug during study
Is receiving concomitant treatment with a strong inhibitor or inducer of CYP3A4/5.
Require continued treatment with a medication that is known to be a strong inducer of CYP3A.
Use of a strong inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to the start of study therapy or expected requirement for use of a strong CYP3A4 inhibitor or inducer during study therapy.
Treatment with a strong CYP3A4 inhibitor or a strong cytochrome P450 inducer within the last 2 weeks
Intake of St. John's wort or hyperforin (potent cytochrome P450 [CYP] 3A4 enzyme inducer) or grapefruit juice (potent CYP3A4 enzyme inhibitor) within 7 days prior to initiation of study treatment
Concurrent use of any medications or substances (e.g. herbal supplement or food) known to be a strong inhibitor or strong inducer of CYP3A4.\r\n* Although corticosteroids are considered to be strong inducers of CYP3A4, physiologic replacement doses of corticosteroids =< 10 mg daily prednisone or equivalent are allowed.
The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:\r\n* St. John’s wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)\r\n* Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4.
The patient has taken a medication known to be a potent inducer of CYP1A2, CYP2C8, or CYP3A4 within 4 weeks prior to the first dose of study drug
Taken a strong inhibitor or inducer of CYP3A4 within 14 days prior to enrollment
The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment: (1) St. John’s wort or hyperforin (potent CYP3A4 enzyme inducer) (2) grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Subjects who are required to use a medication classified as a strong CYP3A inducer of inhibitor
Requires treatment with a strong CYP3A4 inhibitor/inducer
Patient who is on strong inducer/inhibitor of CYP3A needs to be off the medication prior to treatment initiation unless it is medically necessary for the patient
The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:\r\n* St. John’s wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)\r\n* Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Taking a strong inhibitor or inducer of cytochrome P450; intermediate inhibitors are allowed if deemed medically necessary
Has taken a medication that is a potent inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 1-week prior to screening.
Consumption of any concomitant nutritional, herbal supplements, and antioxidants should be taken under the discretion of the investigator; the following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:\r\n* St. John’s wort or hyperforin (potent CYP3A4 enzyme inducer)\r\n* Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Patient who are required to take a strong CYP3A4 inducer are excluded from the study
Has been treated with a cytochrome P450 3A4 (CYP3A4) strong inhibitor or inducer within 7 days of enrollment
A strong or moderate CYP3A inhibitor or inducer within 7 days
Is receiving concomitant treatment with a strong inhibitor or inducer of CYP3A4/5.
Concurrent use of a strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor or inducer; these medications should be discontinued or switched to a different medication with a weaker CYP3A4 interaction prior to enrollment into the study; if patients need to continue the same medication(s), they are excluded from the study
Received a potent CYP3A inhibitor within 7 days or potent CYP3A inducer within 5 weeks prior to first dose of AP32788.
Administration of a strong or moderate CYP3A inhibitor or inducer =< 14 days prior to registration
Treatment with any drug(s) known to be an inhibitor or inducer of cytochrome P450 (CYP)2C19, CYP3A4, CYP2C8, and CYP2E1, within 14 days of the date of first administration of study drug
Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Treatment with a moderate or strong cytochrome P450 3A4 (CYP3A) inhibitor or inducer within 7 days prior to\r\nfirst dose of venetoclax or need for treatment with a strong CYP3A inhibitor or inducer during the period or the study; patients who have a need for treatment with a moderate CYP3A inhibitor or inducer during venetoclax dose escalation will also be excluded
Concurrent use of any medications or substances (e.g. herbal supplement or food) known to be a strong inhibitor or strong inducer of CYP3A4
Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the initiation of study treatment.
Requires treatment with a strong CYP3A inhibitor/inducer.
Receipt of a strong CYP3A4 inducer within 12 days prior to cycle 1 day 1 or a strong CYP3A4 inhibitor within 7 days prior to cycle 1 day 1 (Table 8)
Intake of St. John's wort or hyperforin (potent cytochrome P450 [CYP] 3A4 enzyme inducer) or grapefruit juice (potent CYP3A4 enzyme inhibitor) within 7 days preceding the start of study treatment to the end of treatment
Use of strong CYP3A4 inducer
Patients must not have continued requirement for therapy with a strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitor or inducer
Use of a strong CYP3A4 inducer or inhibitor, or strong CYP2C8 inducer or inhibitor within 3 elimination half-lives of the inhibitor or inducer prior to first dose of study treatment
Patients requiring treatment with a strong CYP3A4 inhibitor or inducer Additional exclusion criteria for PDR001/Panobinostat-
Patients requiring a strong inhibitor or inducer of CYP3A4
Use of potent cytochrome P450 3A4 (CYP3A4) inducer within one week of pacritinib initiation
Requires ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome 3A4 (CYP3A4) enzymes
Use of a strong CYP2C8 inducer or inhibitor within three elimination half-lives of the inducer or inhibitor prior to the start of study treatment.
Current or anticipated use of a P glycoprotein (P gp) inhibitor (eg, dronedarone, quinidine, ranolazine, itraconazole, ketoconazole), strong P gp inducer (eg, rifampin, ritonavir, tipranavir), or strong inhibitor of breast cancer resistance protein (BCRP) (eg, elacridar [GF120918]).
Use of prohibited medications (strong CYP3A4 or CYP2C8 inducers or inhibitors, or moderate CYP2C8 inhibitor trimethoprim) within 3 elimination half-lives of the inducer or inhibitor prior to first dose of the study treatment
The following foods/supplements are prohibited at least 7 days prior to initiation of\r\nand during study treatment:\r\n* St. John’s wort or hyperforin (potent cytochrome P450 family 3, subfamily A, polypeptide 4 [CYP3A4] enzyme inducer)\r\n* Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
Use of any strong CYP3A4 inducer such as rifampin, St John's Wort, or other herbal preparations that contain any strong CYP3A4 inducer (see Table 6 6) 14 days before the first dose of study drug or during the study
Concurrent administration of crizotinib and a strong inhibitor or inducer of cytochrome P450, family 3, subfamily A (CYP3A) is not permitted; many over-the-counter and dietary supplements also inhibit or induce CYP3A and thus are prohibited
St. John's wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)
Use of strong cytochrome P450 3A4 (CYP3A4) inducer within 2 weeks prior to the first dose of MMB
Concurrent therapy with a potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer or inhibitor; subjects may enter screening when therapy with the potent inhibitor or inducer is completed and may begin study treatment after 1 week or 5 half-lives, whichever is longer
Administration or possibility of initiating or continuing any treatment with any known Cytochrome P450 3A4 (CYP3A4) and CYP2C19 enzyme and P-glycoprotein altering drugs (inducer or inhibitor) or non drug agents within 14 days prior to dosing and during the primary objective phase
Patient has received any of the following agents within 3 days prior to study day 1 and/or are planned to receive throughout the duration of the study: opioid antagonist and mixed agonist/antagonist (e.g. pentazocine, buprenorphine, nalbuphine, naloxone/naloxone combinations, naltrexone/naltrexone combinations, methylnaltrexone, alvimopan), a strong cytochrome P450 family 3 subfamily A polypeptide 4 (CYP3A4) and/or P-glycoprotein 1 (P-gp) inhibitor, a moderate CYP3A4 and/or P-gp inhibitor, and/or a strong CYP3A4 inducer
Currently using select CYP2D6 inhibitor or inducer medications
Current use of strong CYP3A4 inducers or inhibitors\r\n* NOTE: patients may be eligible if they transition to an alternative agent or are able to stop CYP3A4 inducer or inhibitor
Subjects on a potent CYP3A4 inhibitor or CPY3A4 inducer who cannot be changed to another medication are excluded
Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the cytochrome P450 (CYP)3A or CYP2C9 pathways (patients should discontinue taking any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A or CYP2C9 pathways)
Participants taking any drug that is a strong inhibitor or inducer of the CYP3A4 enzyme within at least 2 weeks before the start of study drug and during the conduct of the study unless there is an emergent or life-threatening medical condition that requires it