A Study to Test Combination Treatments in People With Advanced Gastric Cancer

Phase 1

• Conditions: Advanced Gastric Cancer; MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002807-24-NL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-27
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

For the master protocol:
-Advanced Gastric Cancer
-Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
-Must have at least 1 lesion with measurable disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

For the master protocol:
-Patients/subjects with HER2 positive tumor that have not been treated with trastuzumab prior to enrollment
-Must not have suspected or known central nervous system metastases unless adequately treated
-Patients/subjects with autoimmune disease
-Patients/subjects who need daily oxygen therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified