Phase 2
N=136
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Advanced or Inoperable Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03427814 ↗Enrolled (actual)
136
Serious AEs
20.6%
Results posted
Sep 2023
Primary outcome: Primary: Progression Free Survival (PFS) by Investigator Assessment — 3.7; 2.1 Months — p== 0.1428
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pamiparib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) by Investigator Assessment |
3.7; 2.1 | = 0.1428 |
| SECONDARY Overall Survival (OS) |
10.2; 12.0 | — |
| SECONDARY Time To Second Subsequent Treatment (TSST) |
9.8; 9.7 | — |
| SECONDARY Objective Response Rate (ORR) |
7.7; 6.3 | — |
| SECONDARY Duration of Response (DOR) |
3.6; NA | — |
| SECONDARY Time To Response |
3.68; 1.87 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
66; 61; 17; 11 | — |
Summary
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.
Eligibility Criteria
Key Inclusion Criteria
- Age ≥ 18 years.
- Signed informed consent.
- Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
- Received platinum based first line chemotherapy for ≤ 28 weeks.
- Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).
- Able to be randomized to study ≤ 8 weeks after last platinum dose.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Adequate hematologic, renal and hepatic function.
- Must be able to provide archival tumor tissue for central biomarker assessment.
- 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
- Unresolved acute effects of prior therapy ≥ Grade 2.
- Prior treatment with PARP inhibitor.
- Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.
- Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.
- Diagnosis of myelodysplastic syndrome (MDS)
- Other diagnoses of significant malignancy
- Leptomeningeal disease or brain metastasis
- Inability to swallow capsules or disease affecting gastrointestinal function.
- Active infections requiring systemic treatment.
- Clinically significant cardiovascular disease
- Pregnant or nursing females.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03427814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.