A study evaluating efficacy of the drug BGB-290 in patients with gastric cancer that responded to previous chemotherapy

Phase 1

• Conditions: Inoperable Locally Advanced or Metastatic Gastric Cancer that Responded to Platinum-based First-line Chemotherapy; MedDRA version: 21.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003493-13-CZ
• Lead Sponsor: BeiGene, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-20
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Patients must meet all of the following criteria to be eligible for the study:
1) Age 18 years
2) Histologically proven adenocarcinoma of the stomach or gastroesophageal junction, inoperable locally advanced or with metastatic disease
a) Patients with gastric cancer overexpressing HER2 are not allowed.
b) Irradiation as part of prior first-line treatment is not allowed.
3) Availability of archival tumor tissue for central laboratory determination of HRD status for randomization and exploratory biomarker analyses
4) Confirmed PR that is maintained for >=4 weeks or CR as determined by the investigator per RECIST Version 1.1

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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 340

Exclusion Criteria

1) Unresolved acute effects of prior therapy of Grade =2
2) Prior treatment with a PARP inhibitor
3) Chemotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or anticancer herbal remedies =14 days prior to randomization
4) Diagnosis of MDS
5) Leptomeningeal disease or brain metastasis
6) Previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome
7) Active bleeding disorder

Study & Design

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