Brief Title
A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy
Official Title
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
Brief Summary
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
(Safety Lead-in) Incidence of ≥3 grade TRAEs
Secondary Outcome
AEs+SAEs
Condition
Ovarian Cancer
Intervention
Fluzoparib; Apatinib
Study Arms / Comparison Groups
Safety Lead-in, Doublet Arm
Description: Fluzoparib+Apatinib
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
690
Start Date
June 2, 2020
Completion Date
April 1, 2024
Primary Completion Date
June 30, 2023
Eligibility Criteria
Inclusion Criteria:
- （phase 3）Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade
serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube
cancer)
- （phase 3）Complete response (CR) or partial response (PR) achieved with front-line
platinum-based chemotherapy regimen as determined by investigator
- （phase 3）Ability to be randomized ≤8 weeks after last dose of platinum
- （Saftey Lead-in）Received 2~4 prior chemotherapy regimens. Platimun sensitive relapsed;
Have at least one measurable disease as defined by RECIST v1.1.
Exclusion Criteria:
- Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
- 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04229615
Organization ID
FZPL-Ⅲ-302
Responsible Party
Sponsor
Study Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor
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Verification Date
April 2022