Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer

BeiGene

Status and phase: Active, not recruiting; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Pamiparib capsule; Drug: Placebo capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03519230

CTR20171666 (Registry Identifier)

BGB-290-302

ChiCTR1800014643 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 224 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups, including a placebo group

Treatment arm

Experimental group

Treatment:

Drug: Pamiparib capsule

Placebo arm

Placebo Comparator group

Treatment:

Drug: Placebo capsule