Last updated on November 2019

Study of BGB-290 or Placebo in Patients With Advanced or Inoperable Gastric Cancer

Brief description of study

This study will enroll subjects with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A subjects will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects with advanced or inoperable gastric cancer.

Detailed Study Description

This is a double-blind, placebo controlled, randomized multicenter global phase 3 study comparing the efficacy and safety of single agent poly (ADP-ribose) polymerase (PARP) inhibitor BGB-290 to placebo as maintenance therapy in subjects with advanced gastric cancer who have responded to first line platinum based chemotherapy. Subjects are randomized 1:1 to BGB-290 (Arm A) or placebo (Arm B). Randomization will be stratified by geography, biomarker status, and ECOG performance status.

Patients will undergo tumor assessments at screening and then every 8 weeks, or as clinically indicated. Administration of BGB-290 or placebo will continue until disease progression, unacceptable toxicity, death, or another discontinuation criterion is met.

After end of treatment, long-term follow-up assessments include tumor imaging every 8 weeks for those patients without disease progression, survival status, and new anticancer therapy.

Clinical Study Identifier: NCT03427814

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St Joseph Heritage Healthcare

Santa Rosa, CA United States
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Wichita, KS United States
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Louisville, KY United States
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Oklahoma City, OK United States
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Renovatio Clincal

The Woodlands, TX United States
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Monash Health

Clayton, Australia
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UZ Antwerpen

Wilrijk, Belgium
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UZ Gent

Gent, Belgium
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ICM Val d'Aurelle

Montpellier Cedex 5, France
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Angers Cedex 2, France
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Queen Mary Hospital

Hong Kong, Hong Kong
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Raffles Hospital

Singapore, Singapore
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Institut Catal d Oncolog a (I.C.O.)

L'Hospitalet de Llobregat, Spain
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Mount Vernon Hospital

Northwood, United Kingdom
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