A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients

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/A

Clinical Study ID

NCT03863860
FZPL-Ⅲ-301-OC
  • Ages > 18
  • Female

Study 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 (CR) or partial response (PR) after platinum-based chemotherapy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (includingprimary peritoneal and fallopian tube cancer)
  2. Completion of ≥2 previous platinum-containing regimens
  3. Complete response (CR) or partial response (PR) achieved with last platinum-basedchemotherapy regimen as determined by investigator
  4. Ability to be randomized ≤8 weeks after last dose of platinum

Exclusion

Exclusion Criteria:

  1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
  2. 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).
  3. 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
    China

    Site Not Available

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