Loading clinical trials...
Loading clinical trials...
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib±Apatinib for Maintenance Treatment in Patients With Advanced Ovarian Cancer Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy
This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Start Date
June 2, 2020
Primary Completion Date
June 30, 2023
Completion Date
April 1, 2024
Last Updated
April 25, 2022
690
ACTUAL participants
Fluzoparib; Apatinib
DRUG
Fluzoparib
DRUG
Placebo
DRUG
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
NCT04550494
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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.
View ClinicalTrials.gov Terms and Conditions