Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Gastrointestinal Agents

All Drugs and Chemicals

Rabeprazole

Proton Pump Inhibitors

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

Subjects in treatment A will administered HMPL-453 at fast overnight condition.

Subjects in treatment B will administered HMPL-453 at high-fat meal condition.

Subjects in treatment C will administered HMPL-453 at low-fat meal condition.

Subjects in treatment D will administered rabeprazole combined with HMPL-453 at low-fat meal condition hour prior to receiving a standardized low-fat meal.

HMPL-453

20 mg of rabeprazole will be administered by mouth once daily.

A Phase 1, Open-label, 4-Period, Randomized 6-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-453 in Healthy Volunteers

Open-label, 4-Period, Randomized 6-Sequence Study

HMPL-453 Food Effect and PPI Study in Healthy Volunteer Study

A Phase 1, Open-label, 4-period, Randomized 6-sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of HMPL-453 in Healthy Volunteers

Area under the concentration time curve from time 0 to the last measurable concentration

Area under the concentration time curve from time 0 extrapolated to infinity

Any untoward medical occurrence associated with the study drug

Time to reach the maximum observed plasma concentration, elimination half-life

Hutchmed

Skin and Connective Tissue Diseases

Melanoma

Anti-Infective Agents

Antineoplastic Agents

Rifampin

Dabrafenib

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Protein Kinase Inhibitors

Subjects will administer Dabrafenib from Day 1 to Day 15, Dabrafenib and Rabeprazole from Day 16 to Day 19, Dabrafenib and Rifampin from Day 20 to Day 29. The serial PK samples will be collected for 12 hours following dosing on Day 15 (Dabrafenib alone), Day 19 (Dabrafenib and Rabeprazole), and Day 29 (Dabrafenib and Rifampin).

Dabrafenib dosed at 150mg twice a day from Day 1 to the morning of Day 29

Dabrafenib 150 mg twice a day (BID)

Rabeprazole dosed at 40mg each morning on Days 16 to 19

Rabeprazole 40 mg once daily (OD)

Rifampin dosed at 600mg each morning on Days 20 to 29

Rifampin 600 mg OD

GSK Clinical Trials

The study is being conducted to evaluate the effect of rifampin (a strong CYP3A4 inducer) and rabeprazole (a pH elevating agent) on the PK of dabrafenib (a CYP3A4/CYP2C8 substrate). The study will be conducted in subjects with BRAF V600 mutation-positive tumors. Data collected from this study will be used to inform recommendations regarding use of concomitant medications with dabrafenib and future clinical pharmacologic evaluation of dabrafenib.

A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors

An Open-label Study to Evaluate the Effects of a Potent CYP3A4 Inducer and the Effects of a pH Elevating Agent on the Repeat Dose Pharmacokinetics of Dabrafenib (GSK2118436) in Subjects With BRAF V600 Mutation Positive Tumors

Blood samples will be collected to assess PK parameters including: maximum observed concentration (Cmax)

Blood samples will be collected to assess PK parameters including: time to Cmax (tmax)

Blood samples will be collected to assess PK parameters including: area under the concentration-time curve over the dosing interval (AUC\[0-tau\])

Blood samples will be collected to assess PK parameters including: Pre-dose concentration (Ctau) after administration of Dabrafenib co-administered with rabeprazole or rifampin

Blood samples will be collected to assess PK parameter (AUC\[0-tau\]) after administration of Dabrafenib co-administered with rabeprazole or rifampin

Blood samples will be collected to assess PK parameters including: Cmax and Ctau, after administration of Dabrafenib co-administered with rabeprazole or rifampin

Blood samples will be collected to assess PK parameter (tmax), after administration of Dabrafenib co-administered with rabeprazole or rifampin

Blood samples will be collected for AUC(0 tau) to estimate ratio of Dabrafenib metabolites to parent Dabrafenib co-administered with rabeprazole or rifampin

Safety and tolerability assessment for vital signs including systolic and diastolic blood pressure, temperature, and pulse rate for dabrafenib in combination with rabeprazole or rifampin

A single 12-lead ECG will be obtained to assess safety and tolerability of dabrafenib in combination with rabeprazole or rifampin

Safety and tolerability assessment for clinical laboratory tests including hematology, clinical chemistry and other tests for dabrafenib in combination with rabeprazole or rifampin

Safety and tolerability assessment includes adverse events (AEs) and serious adverse events (SAEs)

Blood sample will be collected to measure concentration of Rabeprazole in the presence of Dabrafenib

Blood sample will be collected to measure concentration of Rifampin in the presence of Dabrafenib

GlaxoSmithKline

Symptoms and General Pathology

Digestive System Diseases

Hemorrhage

Ulcer

Gastrointestinal Hemorrhage

The rabeprazole group will receive oral rabeprazole 20mg twice day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).

rabeprazole

The placebo group will receive a placebo by mouth twice a day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).

placebo

MyungKu Choi, MD

The purpose of this study is:

* To examine if oral administration of Pariet (proton pump inhibitor, 20mg tablets, twice daily for 5 days) before Endoscopic mucosal resection(EMR) exhibits preventive effects of ulcer bleeding compared with placebo group (preoperative administration of placebo)
* To evaluate the effects on the suppression of acid secretion of preoperative administration of an Proton pump inhibitor

* Endoscopic mucosal resection (EMR) is less invasive than surgery and is known to be general treatment for early gastric cancer or gastric adenoma when patients' quality of life is taken into consideration. However, major complications such as bleeding and perforation remain to be problematic.1-5 The incidence of these complications is expected to rise as the size of lesions for which EMR is indicated has enlarged. Histamine 2 receptor antagonists (H2RA) and proton pump inhibitors (PPI) have been used for the bleeding,1-3 but the bleeding rate following EMR has been reported to be still high as 1.4% to 24%.1,4 Green et al and Berstad et al cited in their research that intragastric PH should be sustained above 5.4 to prevent bleeding, and PPIs should be administered instead of H2RAs to keep PH above 5.4. Being studied are administration modalities to enhance the therapeutic efficacy of PPIs or H2RAs.1-3 Several studies have already demonstrated that high-dose PPI therapy, for which a PPI was administered twice daily, effectively blocks acid secretion by increasing intragastric pH to neutral.3 Our study team also suggested in a previous study that high-dose PPI therapy was adequate to maintain intragastric pH above 6.
* PPIs are known to induce the suppression of acid secretion because they destroy a proton pump, yet it takes 5 days to achieve their maximum effects.7,8 It's been suggested that the onset of PPIs is slow to prevent bleeding with administration of a PPI after EMR.4 Therefore, our investigators expect that 5-day administration of an oral PPI before EMR would increase intragastric pH to above 6 and would be at least equal to or superior to intravenous PPIs currently being used in terms of the suppression of acid secretion.
* This is a prospective, randomized, comparative study to substantiate that oral administration of rabeprazole (Pariet tablets) 20mg twice daily before and after EMR (PO RBP group) will show similar effects on the prevention of bleeding compared with the conventional treatment with iv administration of pantoprazole after EMR but no special medication given before EMR (Placebo group). In addition, we are going to measure intragastric pH among part of study subjects and then to evaluate if the effect of acid suppression in the PO RBP group is superior to that in the placebo group.

Effects of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection

Effects of Preoperative Administration of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection(EMR): Prospective, Randomized, Placebo-controlled, Comparative Study

Janssen Korea, Ltd., Korea

The Catholic University of Korea

MD, PhD

Micronutrients

Hematinics

Vitamins

Nivolumab

Paclitaxel

Albumin-Bound Paclitaxel

Pemetrexed

Cisplatin

Ipilimumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

BMS-986408

Platinum-doublet chemotherapy

Bristol-Myers Squibb

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

Adenoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks.

Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks.

Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast

Ilaprazole

Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast

ChangSeok Bang, MD, PhD

This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.

This study is a Multicenter, Randomized, Parallel and Prospective study to compare Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and to investigate Prevention of gastrointestinal bleeding.

Participants are defined as persons who underwent a Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer. For 8 weeks, Participants treated as Ilaprazole 20mg or Rabeprazole 20mg once a day. After treatment, The ulcer healing rate was evaluated by Endoscopy at 4, 8 weeks.

Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.

Effects of Ilaprazole 20mg on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone Endoscopic Submucosal Dissection(ESD) for Gastric Adenoma or Early Gastric Cancer.

The rate of Ulcer size reduction(Δ) : \[(Initial ulcer size) - (Ulcer size at 8 weeks)\] / (Initial ulcer size)

Apply 0.15% Indigo carmine to scarring of the ulcer and Describe the pattern of the scar as flat, nodular or intermediate at tracking endoscopy.

The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HMPL-453 Food Effect and PPI Study in Healthy Volunteer Study	NCT05930119	Intrahepatic Ch...	HMPL-453 Rabeprazole	18 Years - 55 Years	Hutchmed
A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors	NCT01954043	Cancer	Dabrafenib 150 ... Rabeprazole 40 ... Rifampin 600 mg...	18 Years -	GlaxoSmithKline
A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors	NCT01954043	Cancer	Dabrafenib 150 ... Rabeprazole 40 ... Rifampin 600 mg...	18 Years -	GlaxoSmithKline
Effects of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection	NCT00844675	Early Gastric A... Adenocarcinoma,...	rabeprazole placebo	18 Years - 70 Years	The Catholic University of Korea
A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors	NCT05407675	Advanced Solid ...	BMS-986408 Nivolumab Ipilimumab Platinum-double... Rabeprazole	18 Years -	Bristol-Myers Squibb
Effects of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection	NCT00844675	Early Gastric A... Adenocarcinoma,...	rabeprazole placebo	18 Years - 70 Years	The Catholic University of Korea
Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.	NCT02638584	Gastric Cancer	Ilaprazole Rabeprazole	19 Years - 85 Years	Il-Yang Pharm. Co., Ltd.
A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors	NCT05407675	Advanced Solid ...	BMS-986408 Nivolumab Ipilimumab Platinum-double... Rabeprazole	18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for rabeprazole

Every month we try and update this database with for rabeprazole cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rabeprazole

Every month we try and update this database with for rabeprazole cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rabeprazole cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.