Clinical trial · Interventional
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Inoperable Gastric Cancer | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pamiparib | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pamiparib
- description
- Participants received pamiparib orally.
- interventionNames
- Drug: Pamiparib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants received placebo orally.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) by Investigator Assessment
- timeFrame
- Approximately 23 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key 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. Eastern Cooperative Oncology Group (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. Key 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) 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
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