A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Safety Lead-in or Parallel, Fluzoparib+Apatinib Participants will receive Fluzoparib-Apatinib combination until progression |
Drug: Fluzoparib+Apatinib
Fluzoparib-Apatinib combination
|
Active Comparator: Fluzoparib monotherapy Participants will receive Fluzoparib monotherapy until progression |
Drug: Fluzoparib
Fluzoparib monotherapy
|
Other: Exploratory cohort: Fluzoparib+Apatinib Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression |
Drug: Fluzoparib+Apatinib
Fluzoparib-Apatinib combination
|
Outcome Measures
Primary Outcome Measures
- (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle [up to 28 days]
- (Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib [up to 28 days]
- (Phase 2) Objective response rate(ORR) in relapsed ovarian cancer patients [Assessed up to a maximum of 20 months]
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
- (Exploratory research) Objective response rate(ORR) in relapsed ovarian cancer patients [Assessed up to a maximum of 20 months]
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
Secondary Outcome Measures
- AEs+SAEs [from the first drug administration to within 30 days for the last treatment dose]
Adverse Events and Serious Adverse Events
- Progression free survival (PFS) [up to 20 months]
Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment
- Disease control rate (DCR) [up to 20 months]
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
- Duration of response (DoR) [up to 20 months]
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
- Response rate by RECIST 1.1 criteria [up to 20 months]
- Response rate by GCIG CA125 [up to 20 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
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Patients must have received at least 2 previous platinum-containing regimens.
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At least one target lesion.
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ECOG performance status 0-1.
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Adequate bone marrow, kidney and liver function.
Exclusion Criteria:
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Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ,patients who received PARP inhibitor are eligible;
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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;
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Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
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Known to be human immunodeficiency virus positive;
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Known active hepatitis C virus, or known active hepatitis B virus;
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Untreated and/or uncontrolled brain metastases;
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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;
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Pregnant or breast-feeding women.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FZPL-II-201