Not receiving administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes
No requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes
Requirement for constant administration of proton-pump inhibitor, histamine 2 (H2) antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed while patients are on dexamethasone; we strongly recommend that patients who require gastric protection to receive only antacids starting 24 hours before the first dose until 24 hours after the last dose of alisertib
Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed
Patients who have a requirement for constant administration of proton pump inhibitor, histamine-2 (H2) antagonist, or pancreatic enzymes are not eligible; intermittent usage of antacids or H2 antagonists are allowed
Requirement for constant administration of proton pump inhibitor, histamine 2 (H2) antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed
Requirement for constant administration of proton pump inhibitor, histamine (H2) antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed as described
Requirement for constant administration of proton pump inhibitor, histamine-2 (H2) antagonist, or pancreatic enzymes; histamine-2 (H2) receptor antagonists are not permitted from the day prior (day -1) through to the end of alisertib dosing (e.g., day 7), except as required for premedication for a protocol-specific agent (e.g., taxane); neutralizing antacids and calcium-containing supplements cannot be taken from 2 hours prior to alisertib dosing until up to 2 hours after dosing
Requirement for constant administration of proton pump inhibitor or H2 antagonist; intermittent uses of antacids or H2 antagonists are allowed
Requirement for constant administration of proton pump inhibitors, H2 antagonists, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed
Patient must not require constant administration of a proton pump inhibitor, histamine receptor 2 (H2) antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed
Requirement for constant administration of proton pump inhibitor from 5 days prior to D1 of alisertib, and/or requirement for constant administration of histone 2 (H2) antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed
Patients who are on daily proton pump inhibitor therapy must be able to discontinue use or only require use of antacid or hydrogen (H2) antagonist intermittently; patients who require daily administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes are not eligible; intermittent uses of antacids or H2 antagonists are allowed
Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids or H2 antagonists are allowed (see section 5.5)
Requirement for constant administration of proton pump inhibitor, histamine (H2) antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed
Requirement for constant administration of H2 antagonist
Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs
Patients CANNOT have daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Participants receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A within 7 days of registration; proton pump inhibitors (PPI) may be taken while on study, however it is recommended that the PPI is taken 12 hours from the time of palbociclib administration; if needed, alternative antacid therapies may be used including H2-receptor antagonists and locally acting antacids; H2-receptor antagonists should be administered with a staggered dosing regimen (twice daily); the dosing of palbociclib should occur at least 10 hours after H2-receptor antagonist evening dose and 2 hours before the H2-receptor antagonist morning dose
Subjects requiring daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days prior to study registration
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of the study drugs.
Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug.
Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Patients who are taking proton pump inhibitor (PPI) within 7 days before receiving the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug
Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug
Patients who are taking proton pump inhibitor (PPI) within 7 days before receiving the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug
Treatment with an H2 blocker, other than famotidine; if the subject requires a proton pump inhibitor (PPI), then esomeprazole, pantoprazole, or rabeprazole may be given
History of continuous daily use of PPI more than 1 year prior to consent
Participants requiring daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug.
Treatment with proton pump inhibitor (PPI); patients on PPI therapy prior to enrollment must stop using the PPI for at least 4 days prior to the first dose of MLN8237
Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs
The intermittent use of proton-pump inhibitors (PPI), H2-antagonists and antacids (including carafate) is only allowed within these guidelines:\r\n* PPI until day (D)-5 prior to the first dose of alisertib and prohibited for the duration of the study,\r\n* H2 antagonists until D-1 and after the dosing of alisertib is done,\r\n* Antacid formulations until 2 hours before dosing and after 2 hours following dosing
Inability to tolerate a proton pump inhibitor (PPI)
No concomitant use of proton pump inhibitors (PPI) is allowed; any prior PPI must be discontinued at least one week before receiving MLN0128 (TAK-228)
Regular (>= 2 times per week) use of drugs that alter the pH of the gastrointestinal tract (GI) tract, such as proton pump inhibitors (PPI) and antacids; exceptions: individuals who use prescription PPIs and have approval from their primary health care provider to replace the PPI with an H2 receptor agonist, i.e. ranitidine, for the duration of the trial will be eligible
Chronic proton pump inhibitor (PPI) use or histamine (H2) blocker use that cannot be temporarily discontinued (at least 48 hours)
Proton pump inhibitor use at least once daily for at least twelve months prior to enrolment, and stable dose of PPI for the three months before enrolment
Chronic concomitant treatment with proton pump inhibitors must discontinue the drug for 7 days prior to registration on the study
Patients must not be receiving any proton pump inhibitors at the time of registration
Use of prescription proton pump inhibitors (PPIs) within 12 months prior to study entry\r\n* Dexlansoprazole (Dexilant)\r\n* Pantoprazole (Protonix)\r\n* Rabeprazole (AcipHex)\r\n* Esomeprazole (Nexium)\r\n* Lansoprazole (Prevacid)\r\n* Omeprazole (Prilosec, Zegerid)
A medical condition requiring use of proton pump inhibitors (PPIs); or histamine 2 (H2) receptor antagonists; patients who intermittently use these medications, must meet the following criteria:\r\n* No use of PPIs within 5 days before the first dose of alisertib\r\n* No use of H2 antagonist or pancreatic enzymes within 24 hours before the first dose of alisertib
Proton pump inhibitor: the concomitant use of proton-pump inhibitors (including, but not limited to, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole) with palbociclib is prohibited; recommendations about the use of antacids or H2-receptor antagonists include, but not limited to: cimetidine, famotidine, nizatidine, and ranitidine; if needed, administer H2-receptor antagonists with a staggered dosing regimen (twice daily); the dosing of palbociclib should occur at least 10 hours after H2-receptor antagonist evening dose and 2 hours before the H2-receptor antagonist morning dose; local antacids: as acid lowering agents, local antacids may decrease palbociclib absorption and exposure; however, if needed, local antacids should be given at least 2 hours before or at least 2 hours after palbociclib administration
Proton-pump inhibitors and histamine H2-receptor antagonists;
Patients receiving proton pump inhibitors which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
Treatment with any of the following; histamine receptor 2 inhibitors, proton pump inhibitors or antacids within 3 days or 5 half-lives of administration of BGB234, whichever is longer.
Treatment with proton pump inhibitors within 3 days prior to study entry; if continued use of gastrointestinal (GI) prophylaxis is required, the patient will be switched to an appropriate histamine (H2) antagonist with appropriate counsel and caution
Financial coverage for proton therapy
Participants who require continuous use of proton pump inhibitors (PPIs) or histamine-2 (H2) receptor antagonists and participants who are taking PPIs within 5 days before the first dose of study drug.
Treatment with any of the following: histamine receptor 2 inhibitors, proton pump inhibitors or antacids within 7 days of start of study treatment.
Treated with or eligible to commence prophylactic treatment with a proton-pump inhibitor prior to implantation, and to continue to receive treatment for at least 6 months post implantation
Use of proton-pump inhibitors within 4 days prior to the first dose of study drug. Other medications that increase gastric pH, ie, histamine H2 receptor antagonists and antacids may be taken provided they are not administered within 2 hours before or after administration of study drug.
Participants who are taking proton pump inhibitors (PPIs) within 7 days of the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug.
Need for ongoing therapy with proton pump inhibitors; H2 antagonists are allowed
Patients on proton pump inhibitors, potent CYP3A or P-glycoprotein substrates, inhibitors or inducers a minimum 7 day period washout required unless discontinuation or substitution is not in the best interests of the patient as determined by the investigator; in instances where use of these agents is felt to be required for optimal management, inclusion of such patients should be discussed with the principal investigator (PI) and the rationale documented; these patients, if enrolled on study, may require dose modifications for both axitinib and bosutinib
Histamine 2 (H2) antagonists and proton pump inhibitors are not allowed
Subjects currently receiving H2-blocker or proton pump inhibitors (or unable to stop at least 5 days prior to the first treatment).
Other drugs permitted but use with caution include; drugs are not recommended but can be used with caution\r\n* Antacids: use of H2 blockers and proton pump inhibitors is not recommended; patients who require antacids should use short acting, locally active agents (e.g., Maalox, Mylanta etc.); however, these agents should not be taken within either 2 hours before or 2 hours after the dasatinib dose\r\n* Drugs prolong QT interval; erythromycin, clarithromycin, pentamidine, ondansetron, granisetron, and methadone
Concomitant use of proton pump inhibitors, H2-receptor antagonists, antacids
Treatment with proton pump inhibitors (PPIs) within 7 days prior to enrollment.
Required ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment; if such medications have been used, patients must have discontinued these agents at least 1 week prior to initiating study treatment; examples include:\r\n* Strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and/or strong CYP3A4 inducers;\r\n* Strong inhibitors of P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP);\r\n* Simvastatin and other hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (ie, statins)\r\n* Drugs that raise gastric potential of hydrogen (pH) including proton pump inhibitors and histamine-2 receptor antagonists (hydrogen [H2]-blockers); Note: Short-acting antacids, in place of proton pump inhibitors (PPIs) and H2-blockers, are permitted\r\n* HDAC inhibitors
Concomitant use of acid reducing agents (e.g., proton pump inhibitors, histamine 2 (H2) receptor antagonists, antacids)
The concomitant use of histamine (H)2 blockers and proton pump inhibitors (PPIs) with dasatinib is not recommended; the use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy; if antacid therapy is needed, the antacid dose should be administered two hours before or after the dose of dasatinib; patients who cannot tolerate discontinuation of H2 blockers or PPIs are ineligible
Treatment with proton pump inhibitors within 3 days prior to study entry
Achlorhydria or use of antacids, proton-pump inhibitors, or other drugs known to raise gastric pH within 2 weeks before study drug administration.
Proton pump inhibitors
Current or anticipated need for treatment with proton pump inhibitors (PPI); patients on proton pump inhibitors who can be switched to histamine receptor H2 (H2)-blockers before the start of the study are still eligible
The patient requires treatment with a pH elevating agent, including H2 blockers, proton pump inhibitors, and antacids. If the medication is considered to be medically necessary, the patient should be discussed with the Medical Monitor.
No concurrent administration of cimetidine (as it can decrease the clearance of fluorouracil [5-FU]); another histamine-2 receptor (H2)-blocker or proton pump inhibitor may be substituted before study entry
Subjects who are using prescription or OTC medications (including, for example, proton pump inhibitors, H2 antagonists or calcium carbonate) that reduce or neutralize gastric acidity within 5 half lives before the first dose of study drug. Use of these medications for supportive care after cycle 1 is permitted.
Patients who are taking proton pump inhibitors within 7 days of the first dose or who require treatment with proton pump inhibitors during the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose
Patients should not be on cimetidine; another histamine-2 (H2)-blocker or proton pump inhibitor may be substituted before study entry
Patients should not be on cimetidine; another histamine 2 (H2)-blocker or proton pump inhibitor may be substituted before study entry
Patients should not be on cimetidine; another histamine 2 (H2)-blocker or proton pump inhibitor may be substituted before study entry
Proton pump inhibitors, such as rabeprazole, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, and pantoprazole are prohibited; short acting antacids such as Maalox Maximum Strength are allowed
Proton pump inhibitors and histamine-2 (H2) inhibitors
Subject has received potent CYP 3A4 inhibitors within 7 days prior to first dose of study drug or proton pump inhibitors such as omeprazole within 14 days prior to first dose of study drug.
Has taken proton pump inhibitors within 7 days before the first administration of study drug.
Receiving treatment with long acting proton pump inhibitors, and cannot be discontinued 3 days prior to the start of INC280 treatment and during the course of the study.
Treatment with proton pump inhibitors within 3 days prior to study entry; if treatment with an histamine (H2)-receptor antagonist such as ranitidine is required, erlotinib must be taken 10 hours after the H2-receptor antagonist dosing and at least 2 hours before the next dose of the H2-receptor antagonist; although the effect of antacids on erlotinib pharmacokinetics has not been evaluated, the antacid dose and the erlotinib dose should be separated by several hours, if an antacid is necessary
Concomitant use of proton pump inhibitors or histamine (H)2 blockers
Concomitant treatment with medicinal products that increase the pH (reduce acidity) of the upper gastrointestinal tract, including, but not limited to, proton-pump inhibitors (e.g. omeprazole), H2-antagonists (e.g. ranitidine) and antacids. Patients may be enrolled in the study after a wash-out period sufficient to terminate their effect.
Concomitant treatment with medicinal products that increase the potential hydrogen (pH), reduce acidity of the upper gastrointestinal tract, including, but not limited to, proton-pump inhibitors (e.g. omeprazole), H2-antagonists (e.g. ranitidine) and antacids. Patients may be enrolled in the study after a washout period sufficient to terminate their effect.
Current therapy with proton pump inhibitors
A medical condition requiring use of pancreatic enzymes; daily, chronic, or regular use of proton pump inhibitors (PPIs); or histamine 2 (H2) receptor antagonists. Participants who intermittently use these medications, must meet the following criteria:
Requirement for continued proton pump inhibitor after randomization
Patients should not be taking concomitant medication that are cytochrome P450 3A4 (CYP3A4) inducers or potent inhibitors (+++) and should try to avoid taking proton pump inhibitors and histamine (H2) antagonists during rest of treatment period; the above medications will be continued only if medically necessary and their use will be noted
Must not be receiving tacrolimus or cyclosporine; use of H2 antagonists such as ranitidine, cimetidine and proton pump blockers such as omeprazole are permissible only in conjunction with corticosteroids in the setting of increased intracranial pressure or for spinal cord compression, as these drugs interfere with cytochrome P450 3A4 (CYP3A4); if patients are given such drugs, they must be taken at least 4 hours after intake of everolimus
Use of H2 antagonists such as ranitidine, cimetidine and proton pump blockers such as omeprazole are permissible only in conjunction with corticosteroids in the setting of increased intracranial pressure or for spinal cord compression, as these drugs interfere with CYP3A4; if patients are given such drugs, they must be taken at least 4 hours after intake of everolimus
Receiving histamine type 2 (H2) antagonists (cimetidine, ranitidine, famotidine, nizatidine) or proton pump inhibitors 9lansoprazole, omeprazole, pantoprazole, esomeprazole, raberprazole, dexlansoprazole) AND unable to hold the drug for 24 h prior to and 24 h after each cisplatin course on cycles 1-4
Treatment with any of the following: histamine receptor two inhibitors, protocol pump inhibitors or antacids within three days or five half-lives, whichever is longer
Proton RT
Patients must not have documented history of gastric/duodenal ulcer within the last 12 months; participant must not currently be on treatment for gastric/duodenal ulcer or be experiencing symptoms at study entry; patients with gastroesophageal reflux disease (GERD) are eligible, however, and these patients may receive over-the-counter histamine-2 (H2) antagonists; proton-pump inhibitors, or other prescription-based treatment for GERD
Participants who regularly (>= 2 times per week) use drugs that alter the pH of the gastrointestinal (GI) tract, such as proton pump inhibitors (PPI) and antacids; exceptions: individuals who use prescription PPIs and have approval from their primary health care provider to discontinue for the duration of clinical trial participation may be enrolled; an alternate drug to control gastroesophageal reflux disease (GERD)/peptic ulcer disease (PUD) symptoms will be suggested
Daily therapy with H2 blockers or protein pump inhibitors
Concurrent use of antacids, hydrogen (H2) antagonists, proton-pump inhibitors, or medications known to inhibit or induce hepatic enzyme cytochrome P450 (CYP) 3A4
No use of proton pump inhibitors (PPIs) within the previous 3 months
For weekly MLN0128 (TAK-228) dose cohorts, patients taking proton pump inhibitors (PPIs) are ineligible unless these patients are able to switch to a histamine (H2) blocker and/or antacid
Intestinal motility agents, histamine?2 inverse agonists (H?2 blockers), or proton pump inhibitors
Treatment with long-acting proton pump inhibitors that cannot be discontinued 3 days prior to the start of study drug and during the course of the study
Chronic proton pump inhibitor, H2-blocker (i.e., ranitidine, famotidine), and/or calcium carbonate use
Concurrent use of any proton pump inhibitors