Active — Not RecruitingPhase 3

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

China224 participantsStarted 2018-05-14

Plain-language summary

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

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
✓. Completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin)
✓. 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
✓. Ability to be randomized ≤8 weeks after last dose of platinum

Exclusion criteria

✕. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
✕. Progressive disease (PD) as per CA-125 criteria before randomization
✕. Diagnosis of myelodysplastic syndrome (MDS)
✕. Known history of intolerance to the excipients of the Pamiparib capsule

What they're measuring

Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment

Timeframe: up to 8 years

Trial details

NCT IDNCT03519230

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-01

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