BGB-290-303

Phase 2

Completed

• Conditions: Inoperable Locally Advanced or Metastatic GastricCancer

• Registration Number: JPRN-jRCT2080225173
• Lead Sponsor: Beigene ( ICCC: Parexel International)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1.Age >= 18 years.
2.Signed informed consent.
3.Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
4.Received platinum based first line chemotherapy for <= 28 weeks.
5.Confirmed partial response (PR) maintained for >= 4 weeks or complete response (CR).
6.Able to be randomized to study <=8 weeks after last platinum dose.
7.ECOG performance status <= 1.
8.Adequate hematologic, renal and hepatic function.
9.Must be able to provide archival tumor tissue for central biomarker assessment.
10.Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last dosing.

Exclusion Criteria

1.Unresolved acute effects of prior therapy >= Grade 2.
2.Prior treatment with PARP inhibitor.
3.Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy<= 14 days prior to randomization.
4.Major surgery or significant injury <=2 weeks prior to start of study treatment.
5.Diagnosis of myelodysplastic syndrome (MDS) or active bleeding disorder.
6.Other diagnoses of significant malignancy
7.Leptomeningeal disease or brain metastasis
8.Inability to swallow capsules or disease affecting gastrointestinal function.
9.Active infections requiring systemic treatment.
10.Clinically significant cardiovascular disease
11.Pregnant or nursing females

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Progression free survival [ Time Frame: From randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first up to 5 years ]<br>The primary objective of this study is to compare progression free survival between treatment groups (BGB-290 versus placebo) as determined by Investigator.