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Completed

NCT Number: NCT04517357

A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.

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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 recurrent ovarian,fallopian tube,or peritoneal cancer.
  • Patients must have received at least 2 previous platinum-containing regimens.
  • At least one target lesion.
  • ECOG performance status 0-1.
  • Adequate bone marrow, kidney and liver function.

Exclusion criteria

  • Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ,patients who received PARP inhibitor are eligible;
  • Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;
  • Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
  • Known to be human immunodeficiency virus positive;
  • Known active hepatitis C virus, or known active hepatitis B virus;
  • Untreated and/or uncontrolled brain metastases;
  • Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;
  • Pregnant or breast-feeding women.

Treatment and study plan

Fluzoparib+Apatinib

Drug

Fluzoparib-Apatinib combination

Fluzoparib

Drug

Fluzoparib monotherapy

Primary outcomes

  1. (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle

    Time frame: up to 28 days

  2. (Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib

    Time frame: up to 28 days

  3. (Phase 2) Objective response rate(ORR) in relapsed ovarian cancer patients

    Time frame: Assessed up to a maximum of 20 months

    Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment

  4. (Exploratory research) Objective response rate(ORR) in relapsed ovarian cancer patients

    Time frame: Assessed up to a maximum of 20 months

    Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment

Secondary outcomes

  1. AEs+SAEs

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

    Adverse Events and Serious Adverse Events

  2. Progression free survival (PFS)

    Time frame: up to 20 months

    Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment

  3. Disease control rate (DCR)

    Time frame: up to 20 months

    Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1

  4. Duration of response (DoR)

    Time frame: up to 20 months

    Time from documentation of tumor response to disease progression assessed among patients who had an objective response

  5. Response rate by RECIST 1.1 criteria

    Time frame: up to 20 months

  6. Response rate by GCIG CA125

    Time frame: up to 20 months

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Aug 18, 2020
Registry last updated
Feb 24, 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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