Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Carcinoid Tumor

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Gastrointestinal Agents

All Drugs and Chemicals

Lansoprazole

Dexlansoprazole

Proton Pump Inhibitors

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

lansoprazole

Stan Van Uum, MD PhD

The goal of this study is to compare several methods for measurement of Chromogranin A in their ability to serve as a marker for disease activity in patients with neuroendocrine tumors.

Further, in a subgroup, we will determine if taking a proton pump inhibitor affects Chromogranin A levels.

Patient group: patients with neuroendocrine tumors (active or inactive) Healthy volunteers

Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples

For determination of normal CgA range, we will recruit 60 healthy subjects (30 female, 30 male), in whom a single plasma sample will be obtained for measurement of CgA B For determination of CgA in patients with carcinoid disease (active or inactaive), we wil recruit 200 patients with carcinoid disease from our local neuroendocinre oncology clinic.

To determine the effect of PPI on chromogranin A concentration, we will recruit a subgroup of 12 healthy subjects who will take a bedtime lansoprazole 30 mg for 7 days. Fasting serum samples for CgA will be obtained at day 7 and 1, 2, 4, and 7 days after discontinuation of the PPI.

University of Western Ontario, Canada

Principle investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Endometrial Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

Micronutrients

Antirheumatic Agents

Bone Density Conservation Agents

Antipyretics

Anti-Inflammatory Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Vitamins

Pembrolizumab

Cyclophosphamide

Immunomodulating Agents

Vitamin D

Cholecalciferol

Aspirin

Curcumin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Trace Elements

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Vitamin D3

Calciferol

Pembrolizumab, immune modulatory cocktail composed of Vitamin D, Lansoprazole Teva, Cyclophosphamide and Aspirine, radiation and Curcumin

Radiation

Hannelore Denys, MD, PhD

This is a Phase II study in patients with advanced and/refractory cervical cancer, endometrial carcinoma or uterine sarcoma.

Patients will be treated with an immunomodulatory cocktail (Vitamin D, aspirin, Cyclophosphamide and Lansoprazole), followed by pembrolizumab, combined with radiation. In addition, patients will take Curcumin, a food supplement.

This is a Phase II multi-center, open-label, non-randomized, 3-cohort study in patients with advanced and/or refractory cervical cancer, endometrial carcinoma or uterine sarcoma. Patients will be treated by an immunomodulatory cocktail (consisting of a daily intake of 2000 IU Vitamin D, 325 mg aspirin, 50 mg Cyclophosphamide and 180 or 30 mg Lansoprazole alternating weekly), followed by pembrolizumab administered intravenously at 200 mg in 21-day treatment cycles, combined with radiation (3x 8Gy in 48h-intervals). In addition, patients will take Curcumin, a food supplement on a daily basis.

Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer

A Phase II Investigation of Pembrolizumab (Keytruda) in Combination With Radiation and an Immune Modulatory Cocktail in Patients With Cervical and Uterine Cancer (PRIMMO Trial)

Efficacy (objective response rate) at week 26 according to immune related response criteria (irRC)

The number of unmanageable dose limiting toxicities will be reported for the run-in period and the main trial. This analysis will be performed for both the Full Analysis Set (FAS; evaluable patiënts) and extended FAS (eFAS; all patients included in the trial).

Objective response rate at week 26 according to RECIST criteria

At weeks 26, 52, 75, 104, 130 and 156 the proportion of progression-free patients will be estimated with a 95% confidence interval.

At weeks 26, 52, 75, 104, 130 and 156 the median PFS will be calculated.

At weeks 26, 52, 75, 104, 130 and 156 the proportion of patients surviving will be estimated with a 95% confidence interval.

At weeks 26, 52, 75, 104, 130 and 156 the median survival will be calculated.

Quality of life as measured by FACT-Cx questionnaire for the cervical cancer group and by the FACT-G questionnaire for the endometrial carcinoma and uterine sarcoma group. Descriptive statistics of the total score at each visit and the difference with the baseline visit for all other visits will be reported.

Kom Op Tegen Kanker

Anticancer Fund, Belgium

University Hospital, Ghent

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

33 patients who will receive neoadjuvant chemotherapy and lansoprazole 60 mg twice daily four days before starting chemotherapy regimen and then the same dose will be used during chemotherapy cycles

33 patients who will receive neoadjuvant chemotherapy and placebo capsules.

administration of lansoprazole 60 mg twice daily 4 days before starting neoadjuvant chemotherapy regimen and continue till end of chemotherapy cycles

administration of Placebo capsule twice daily 4 days before starting neoadjuvant chemotherapy regimen and continue till end of chemotherapy cycles

Placebo

Investigation of the possible efficacy and safety of lansoprazole co-administration with neoadjuvant chemotherapy in tumor response in women with breast cancer who will be planned for surgery.

Several studies revealed that PPIs inhibit not only the H+/K+ ATPase in gastric parietal cells, but also the vacuolar H+ ATPase (V-ATPase) overexpressed in tumor cells, the V-ATPase is an ATP-dependent proton pump that transports H+ across both intracellular and plasma membranes to regulate intracellular and extracellular pH.

Co-administration or pretreatment with PPIs could inhibit H+ transport via the V-ATPase in tumor cells, resulting in lower extracellular acidification and intracellular acidic vesicles which increase the sensitivity of the tumor cells to the anticancer agents. Moreover, the low extracellular pH induces an increased activity of drug efflux pumps P-glycoprotein (P-gp), which is closely associated with multi-drug resistance (MDR) of tumors. As a consequence, there remains a lower concentration of chemotherapeutic drugs in tumor cells and reduced cytotoxic efficacy, thus restoring the normal extracellular PH will decrease MDR.

The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer

- Tumor response evaluation will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

- Assessment of the level of Ki-67 expression in cancer cells through a staining process (a marker of cancer cell proliferation).

- Assessment of P-gp level by ELISA Kits according to manufacturer's instructions.

- Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.

measurement of serum creatinine levels in (mg/dl) and blood urea nitrogen (BUN) levels in (mg/dl) from blood samples will be assessed monthly for all participants.

measurement of alanine transaminase (ALT) and aspartate transaminase (AST) both in U/L from blood samples will be assessed monthly for all participants.

measurement of the counts of red blood cells, white blood cells, platelets, hemoglobin and hematocrit will be assessed monthly for all participants.

Tanta University

Principal investigator

Digestive System Diseases

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Esomeprazole

Debra Silberg, MD

The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients

An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

An Open-Label, 2-Way Crossover Study of Steady-State Intragastric pH Control Comparing 2 Dosage Regimens of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

AstraZeneca

Serabelisib

TAK-117900 milligram (mg), capsules, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, tablets, orally, once on Day 15.

TAK-117 900 mg tablets, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, capsules, orally, once on Day 15.

TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 15.

TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 15.

TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 1, followed by lansoprazole 30 mg, tablets or capsules, once daily from Day 10 to Day 15, followed by TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 15.

TAK-117

Medical Director

The purpose of this study is to evaluate the relative bioavailability of a new tablet formulation of TAK-117 (new clinical trial material \[NTM\]) compared to the TAK-117 Process B capsules (current clinical trial material \[CTM\]) (Part 1), to assess the effects of food on the oral bioavailability and pharmacokinetics (PK) of TAK-117 (Part 2), and to assess the effects of gastric pH-modifying agent on the PK of TAK-117 in healthy participants (Part 3).

The drug being tested in this study is called TAK-117. TAK-117 is being tested to treat people who have advanced solid tumors. This study will look at the PK and relative bioavailability of new tablet formulation of TAK-117 as compare to current capsule formulation in Part 1. In Part 2 and Part 3, interaction of TAK-117 with food and a gastric pH modifying agent will be evaluated respectively in healthy participants, and will commence only after the completion of Part 1.

The study will enroll approximately 54 participants. In Part 1, participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 2 crossover sequences:

* Sequence A: TAK-117 capsules (9\*100 mg) first then TAK-117 tablets (3\*300 mg)
* Sequence B: TAK-117 tablets (3\*300 mg) first then TAK-117 capsules (9\*100 mg)

Part 2 and Part 3 will be evaluated only on the new tablet formulation of TAK-117 at the dose determined in Part 1. In Part 2, participants will be randomly assigned to receive a single dose of TAK-117 in the fasted state followed by TAK-117 with standard high-fat breakfast in Sequence A or vice-versa in Sequence B. In Part 3, participants will receive a single dose of TAK-117 on Day 1 followed by lansoprazole 30 mg on Day 10 for 6 days and then second dose of TAK-117 on Day 15. Blood samples will be collected at predose and up to 72 hours postdose at prespecified time points on Days 1 and 15. Urine samples will be collected predose, 0 to 12 hours, and 12 to 24 hours postdose in Part 1 only.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 45 days. Participants will make 2 visits to the clinic in each part, during which they will remain confined to the clinic for a 4 to 10 day period for drug dosing and other study procedures. Participants will also complete a final visit 30 to 33 days after their last dose of study drug for a follow-up assessment (Day 45).

A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants

A Phase 1, Open-Label Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of MLN1117 in Healthy Subjects

Millennium Pharmaceuticals, Inc.

At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.

TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 1 or 15 of intervention period.

Part-1: TAK-117 900 mg Capsules

TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 or 15 of intervention period.

Part-1: TAK-117 900 mg Tablets

TAK-117 2\*300 mg, tablets (NTM), orally, once in a fasted state on Day 1 or 15 of intervention period.

Part-2: TAK-117 600 mg Fasted

TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 1 or 15 of intervention period.

Part-2: TAK-117 600 mg Fed

TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1.

Part-3: TAK-117 900 mg

Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 14.

Part-3: Lansoprazole 30 mg

Lansoprazole 30 mg, capsule, orally, once daily on Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 15.

Part 3: Lansoprazole 30 mg + TAK-117 900 mg

TAK-117 9\*100 mg, capsules (current clinical trial material \[CTM\]), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 3\*300 mg, tablets (new clinical trial material \[NTM\]), orally, once on Day 15 (second intervention).

Part-1: TAK-117 900 mg Capsules + TAK-117 900 mg Tablets

TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 9\*100 mg, capsules (CTM), orally, once on Day 15 (second intervention).

Part-1: TAK-117 900 mg Tablets + TAK-117 900 mg Capsules

TAK-117 2\*300 mg, tablets (NTM), orally, once in the fasted state on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2\*300 mg, tablets (NTM), orally, with a standard high-fat breakfast, once on Day 15 (second intervention).

Part-2: TAK-117 600 mg Fasted + TAK-117 600 mg Fed

TAK-117 2\*300 mg, tablets (NTM), orally, once with a standard high-fat breakfast on Day 1 (first intervention), followed by washout from Day 2 to Day 14, further followed by TAK-117 2\*300 mg, tablets (NTM), orally, in the fasted state, once on Day 15 (second intervention).

Part-2: TAK-117 600 mg Fed + TAK-117 600 mg Fasted

TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 1, followed by lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally, once on Day 15 approximately 1 hour (hr) after the last dose of lansoprazole 30 mg.

Part-3: TAK-117 900 mg + Lansoprazole 30 mg

Total

18-45 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Safety analysis population included all the participants who received at least 1 dose of study drug.

Analysis of variance was performed for calculating 90 percent (%) confidence intervals (CIs) for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet versus capsule dosage form.

Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with food versus without food.

Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.

Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)

Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)

Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)

Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)

Part-3: TAK-117 900 mg (3*300 mg Tablets)

Lansoprazole 30 mg, capsule, orally, once daily from Day 10 to Day 15 along with TAK-117 3\*300 mg, tablets (NTM), orally once on Day 15.

Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg

The pharmacokinetic (PK)-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.

Cmax: Maximum Observed Plasma Concentration for TAK-117

The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117

Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet versus capsule dosage form.

Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with food versus without food.

Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117

Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet versus capsule dosage form.

Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with food versus without food.

Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.

The PK-evaluable population where data at specified time points were available. The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples	NCT01216267	Neuroendocrine ...	Lansoprazole lansoprazole	18 Years - 70 Years	University of Western Ontario, Canada
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples	NCT01216267	Neuroendocrine ...	Lansoprazole lansoprazole	18 Years - 70 Years	University of Western Ontario, Canada
Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer	NCT03192059	Cervical Cancer Endometrial Can... Uterine Cancer	Pembrolizumab Radiation Vitamin D Aspirin Lansoprazole Cyclophosphamid... Curcumin	18 Years -	University Hospital, Ghent
The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer	NCT04874935	Breast Cancer	Lansoprazole Placebo	18 Years - 70 Years	Tanta University
An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients	NCT00352261	Barrett's Esoph...	Esomeprazole Lansoprazole	18 Years - 70 Years	AstraZeneca
A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants	NCT02625259	Neoplasm, Advan...	TAK-117 Lansoprazole TAK-117	18 Years - 45 Years	Takeda
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples	NCT01216267	Neuroendocrine ...	Lansoprazole lansoprazole	18 Years - 70 Years	University of Western Ontario, Canada
The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer	NCT04874935	Breast Cancer	Lansoprazole Placebo	18 Years - 70 Years	Tanta University

Spots Global Cancer Trial Database for lansoprazole

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