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

Last updated: February 21, 2025
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Ovarian Cysts

Recurrent Ovarian Cancer

Treatment

Fluzoparib+Apatinib

Fluzoparib

Clinical Study ID

NCT04517357
FZPL-II-201
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically diagnosed high-grade serous or endometrioid recurrentovarian,fallopian tube,or peritoneal cancer.

  2. Patients must have received at least 2 previous platinum-containing regimens.

  3. At least one target lesion.

  4. ECOG performance status 0-1.

  5. Adequate bone marrow, kidney and liver function.

Exclusion

Exclusion Criteria:

  1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.Forexploratory cohort ,patients who received PARP inhibitor are eligible;

  2. Prior malignancy unless curatively treated and disease-free for > 5 years prior tostudy entry. Prior adequately treated non-melanoma skin cancer, in situ cancer ofthe cervix allowed;

  3. Radiation or anti-hormonal therapy or anticancer therapy within 14 days before firstadministration;

  4. Known to be human immunodeficiency virus positive;

  5. Known active hepatitis C virus, or known active hepatitis B virus;

  6. Untreated and/or uncontrolled brain metastases;

  7. Patients with clinical symptoms of cancer ascites, pleural effusion, who need todrainage, or who have undergone ascites drainage within 3 months prior to the firstadministration;

  8. Pregnant or breast-feeding women.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Fluzoparib+Apatinib
Phase: 2
Study Start date:
October 16, 2020
Estimated Completion Date:
November 01, 2024

Connect with a study center

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Jiangsu HengRui Medicine Co., Ltd.

    Shanghai,
    China

    Site Not Available

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