Status:
COMPLETED
A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2025
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT03863860
Start Date
April 30 2019
End Date
June 19 2025
Last Update
July 3 2025
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China