Last updated: June 10, 2022
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Not Recruiting
Phase
3
Condition
Vaginal Cancer
Ovarian Cysts
Ovarian Cancer
Treatment
N/AClinical Study ID
NCT03863860
FZPL-Ⅲ-301-OC
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically diagnosed high-grade serous or endometrioid ovarian cancer (includingprimary peritoneal and fallopian tube cancer)
- Completion of ≥2 previous platinum-containing regimens
- Complete response (CR) or partial response (PR) achieved with last platinum-basedchemotherapy regimen as determined by investigator
- Ability to be randomized ≤8 weeks after last dose of platinum
Exclusion
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 thefirst administration(< 5 elimination half-lives of the study drug molecular targetedanti-cancer drugs).
- Patients with clinical symptoms of cancer ascites, pleural effusion, who need todrainage, or who have undergone ascites drainage within 2 months prior to the firstadministration.
Study Design
Total Participants: 252
Study Start date:
April 30, 2019
Estimated Completion Date:
December 31, 2022
Connect with a study center
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing
ChinaSite Not Available
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