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COMPLETEDPHASE3

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

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

NCT03863860•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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
•3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator
•4. Ability to be randomized ≤8 weeks after last dose of platinum

Exclusion Criteria

•1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
•2. 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).
•3. 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.

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Key Dates

Start Date

April 30, 2019

Primary Completion Date

January 10, 2022

Completion Date

June 19, 2025

Last Updated

July 3, 2025

Enrollment

252

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

Fluzoparib capsules

DRUG

Placebo capsules

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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