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OpenTrials
Completed

NCT Number: NCT03863860

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 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.

Treatment and study plan

Fluzoparib Capsules

Drug

Fluzoparib capsules

Other names: SHR-3162

placebo capsules

Drug

Placebo capsule

Other names: Placebo

Primary outcomes

  1. Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients

    Time frame: up to 2 years

    Defined as progression free survival per RECIST 1.1 criteria

  2. Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant

    Time frame: up to 2 years

    Defined as progression free survival per RECIST 1.1 criteria

Secondary outcomes

  1. Progression free survival(PFS) in relapsed ovarian cancer patients

    Time frame: up to 2 years

    PFS is Progression-Free-Survival per RECIST 1.1 criteria

  2. Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria

    Time frame: up to 2 years

    TTP is Time to Progression

  3. Chemotherapy free interval (CFI) CFI

    Time frame: up to 2 years

    CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen)

  4. overall survival(OS)

    Time frame: up to 3 years

    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

  5. Objective Response Rate

    Time frame: At baseline,at the time point of every 12 weeks, up to 2 years

    Objective Response Rate complete or partial response per RECIST 1.1 criteria

  6. Adverse Events(AEs) and Serious Adverse Events (SAEs)

    Time frame: from the first drug administration to within 30 days for the last treatment dose

    assess the safety and tolerability of Fluzoparib maintenance monotherapy in platinum sensitive relapsed ovarian cancer patients by record the number of Participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Mar 5, 2019
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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