--- a +++ b/clusters/9knumclustersv2/clust_1361.txt @@ -0,0 +1,49 @@ +Use of prescription proton pump inhibitors (PPIs) within 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 (H) receptor antagonists; patients who intermittently use these medications, must meet the following criteria:\r\n* No use of PPIs within days before the first dose of alisertib\r\n* No use of H antagonist or pancreatic enzymes within 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 H-receptor antagonists include, but not limited to: cimetidine, famotidine, nizatidine, and ranitidine; if needed, administer H-receptor antagonists with a staggered dosing regimen (twice daily); the dosing of palbociclib should occur at least hours after H-receptor antagonist evening dose and hours before the H-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 hours before or at least hours after palbociclib administration +Proton-pump inhibitors and histamine H-receptor antagonists; +Treatment with any of the following; histamine receptor inhibitors, proton pump inhibitors or antacids within days or half-lives of administration of BGB, whichever is longer. +Treatment with proton pump inhibitors within days prior to study entry; if continued use of gastrointestinal (GI) prophylaxis is required, the patient will be switched to an appropriate histamine (H) antagonist with appropriate counsel and caution +Participants who require continuous use of proton pump inhibitors (PPIs) or histamine- (H) receptor antagonists and participants who are taking PPIs within days before the first dose of study drug. +Treatment with any of the following: histamine receptor inhibitors, proton pump inhibitors or antacids within days of start of study treatment. +Use of proton-pump inhibitors within days prior to the first dose of study drug. Other medications that increase gastric pH, ie, histamine H receptor antagonists and antacids may be taken provided they are not administered within hours before or after administration of study drug. +Need for ongoing therapy with proton pump inhibitors; H antagonists are allowed +Not receiving administration of proton pump inhibitor, H antagonist, or pancreatic enzymes +No requirement for constant administration of proton pump inhibitor, H antagonist, or pancreatic enzymes +Histamine (H) antagonists and proton pump inhibitors are not allowed +Requirement for constant administration of proton-pump inhibitor, histamine (H) antagonist, or pancreatic enzymes; intermittent uses of antacids or H antagonists are allowed while patients are on dexamethasone; we strongly recommend that patients who require gastric protection to receive only antacids starting hours before the first dose until hours after the last dose of alisertib +Concomitant use of proton pump inhibitors, H-receptor antagonists, antacids +Concomitant use of acid reducing agents (e.g., proton pump inhibitors, histamine (H) receptor antagonists, antacids) +The concomitant use of histamine (H) blockers and proton pump inhibitors (PPIs) with dasatinib is not recommended; the use of antacids should be considered in place of H 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 H blockers or PPIs are ineligible +Requirement for constant administration of proton pump inhibitor, H antagonist, or pancreatic enzymes; intermittent uses of antacids or H antagonists are allowed +Patients who have a requirement for constant administration of proton pump inhibitor, histamine- (H) antagonist, or pancreatic enzymes are not eligible; intermittent usage of antacids or H antagonists are allowed +Achlorhydria or use of antacids, proton-pump inhibitors, or other drugs known to raise gastric pH within weeks before study drug administration. +Requirement for constant administration of proton pump inhibitor, histamine (H) antagonist, or pancreatic enzymes; intermittent uses of antacids or H antagonists are allowed +The patient requires treatment with a pH elevating agent, including H 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 [-FU]); another histamine- receptor (H)-blocker or proton pump inhibitor may be substituted before study entry +Requirement for constant administration of proton pump inhibitor, histamine (H) antagonist, or pancreatic enzymes; intermittent uses of antacids or H antagonists are allowed as described +Requirement for constant administration of proton pump inhibitor, histamine- (H) antagonist, or pancreatic enzymes; histamine- (H) receptor antagonists are not permitted from the day prior (day -) through to the end of alisertib dosing (e.g., day ), except as required for premedication for a protocol-specific agent (e.g., taxane); neutralizing antacids and calcium-containing supplements cannot be taken from hours prior to alisertib dosing until up to hours after dosing +Requirement for constant administration of proton pump inhibitor or H antagonist; intermittent uses of antacids or H antagonists are allowed +Requirement for constant administration of proton pump inhibitors, H antagonists, or pancreatic enzymes; intermittent uses of antacids or H antagonists are allowed +Patients should not be on cimetidine; another histamine- (H)-blocker or proton pump inhibitor may be substituted before study entry +Patient must not require constant administration of a proton pump inhibitor, histamine receptor (H) antagonist, or pancreatic enzymes; intermittent uses of antacids or H antagonists are allowed +Patients should not be on cimetidine; another histamine (H)-blocker or proton pump inhibitor may be substituted before study entry +Patients should not be on cimetidine; another histamine (H)-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- (H) inhibitors +Requirement for constant administration of proton pump inhibitor from days prior to D of alisertib, and/or requirement for constant administration of histone (H) antagonist, or pancreatic enzymes; intermittent uses of antacids or H antagonists are allowed +Has taken histamine-H receptor antagonists and/or neutralizing antacids within hours before the first administration of study drug. +Treatment with proton pump inhibitors within days prior to study entry; if treatment with an histamine (H)-receptor antagonist such as ranitidine is required, erlotinib must be taken hours after the H-receptor antagonist dosing and at least hours before the next dose of the H-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) 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), H-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), H-antagonists (e.g. ranitidine) and antacids. Patients may be enrolled in the study after a washout period sufficient to terminate their effect. +A medical condition requiring use of pancreatic enzymes; daily, chronic, or regular use of proton pump inhibitors (PPIs); or histamine (H) receptor antagonists. Participants who intermittently use these medications, must meet the following criteria: +Patients who are on daily proton pump inhibitor therapy must be able to discontinue use or only require use of antacid or hydrogen (H) antagonist intermittently; patients who require daily administration of proton pump inhibitor, H antagonist, or pancreatic enzymes are not eligible; intermittent uses of antacids or H antagonists are allowed +Requirement for constant administration of proton pump inhibitor, H antagonist, or pancreatic enzymes. Intermittent uses of antacids or H antagonists are allowed (see section .) +Requirement for continued proton pump inhibitor after randomization +Requirement for constant administration of proton pump inhibitor, histamine (H) antagonist, or pancreatic enzymes; intermittent uses of antacids or H antagonists are allowed +Receiving histamine type (H) antagonists (cimetidine, ranitidine, famotidine, nizatidine) or proton pump inhibitors lansoprazole, omeprazole, pantoprazole, esomeprazole, raberprazole, dexlansoprazole) AND unable to hold the drug for h prior to and h after each cisplatin course on cycles - +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 +Concurrent use of antacids, hydrogen (H) antagonists, proton-pump inhibitors, or medications known to inhibit or induce hepatic enzyme cytochrome P (CYP) A +For weekly MLN (TAK-) dose cohorts, patients taking proton pump inhibitors (PPIs) are ineligible unless these patients are able to switch to a histamine (H) blocker and/or antacid +Intestinal motility agents, histamine? inverse agonists (H? blockers), or proton pump inhibitors