Status:
COMPLETED
A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Relapsed Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04517357
Start Date
October 16 2020
End Date
November 1 2024
Last Update
February 24 2025
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000