Clinical trial

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With BGB-290 Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Name
BGB-290-302
Description
To evaluate the efficacy, safety and tolerability of maintenance therapy with BGB-290(Pamiparib) versus placebo in Chinese participants with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy
Trial arms
Trial start
2018-05-14
Estimated PCD
2025-06-30
Trial end
2026-06-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Pamiparib capsule
60 mg twice daily (BID), orally (per os-PO)
Arms:
Treatment arm
Other names:
BGB-290
Placebo capsule
60mg BID, PO
Arms:
Placebo arm
Size
216
Primary endpoint
Progression free survival
Up to 2 years
Eligibility criteria
Key Inclusion Criteria: 1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) 2. Completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin) 3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 4. Ability to be randomized ≤8 weeks after last dose of platinum Key Exclusion Criteria: 1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor 2. Progressive disease (PD) as per CA-125 criteria before randomization 3. Diagnosis of myelodysplastic syndrome (MDS) 4. Known history of intolerance to the excipients of the Pamiparib capsule NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 216, 'type': 'ESTIMATED'}}
Updated at
2024-05-07

1 organization

2 products

1 indication

Product
Pamiparib
Indication
Ovarian Cancer
Organization
BeiGene
Product
Placebo