CompletedPhase 3

A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients

China252 participantsStarted 2019-04-30

Plain-language summary

To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients 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
✓. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator
✓. Ability to be randomized ≤8 weeks after last dose of platinum

Exclusion criteria

✕. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
✕. Patients who have received other study drug treatment within 4 weeks prior to the first administration(\< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).
✕. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.

What they're measuring

Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients

Timeframe: up to 2 years

Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant

Timeframe: up to 2 years

Trial details

NCT IDNCT03863860

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-10

View on ClinicalTrials.gov More Ovarian Cancer trials