A Study of Fluzoparib Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

  • STATUS
    Recruiting
  • End date
    Feb 25, 2024
  • participants needed
    680
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 25 January 2021
cancer
measurable disease
chemotherapy regimen
cancer chemotherapy
ovarian cancer
fallopian tube
apatinib
platinum-based chemotherapy
cancer of the ovary

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.

Details
Condition Ovarian disorder, Fallopian Tube Cancer, Ovarian Cancer, Ovarian Function, Primary Peritoneal Cancer, Primary Peritoneal Carcinoma, Recurrent Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, fallopian tube cancers, ovarian tumors
Treatment Placebo, Fluzoparib, Fluzoparib; Apatinib
Clinical Study IdentifierNCT04229615
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

phase 3Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
phase 3Complete response (CR) or partial response (PR) achieved with front-line platinum-based chemotherapy regimen as determined by investigator
phase 3Ability to be randomized 8 weeks after last dose of platinum
Saftey Lead-inReceived 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
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