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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
(Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle
Time frame: up to 28 days
(Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib
Time frame: up to 28 days
(Phase 2) Objective response rate(ORR) in relapsed ovarian cancer patients
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
Time frame: Assessed up to a maximum of 20 months
(Exploratory research) Objective response rate(ORR) in relapsed ovarian cancer patients
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
Time frame: Assessed up to a maximum of 20 months
AEs+SAEs
Adverse Events and Serious Adverse Events
Time frame: from the first drug administration to within 30 days for the last treatment dose
Progression free survival (PFS)
Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment
Time frame: up to 20 months
Disease control rate (DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Time frame: up to 20 months
Duration of response (DoR)
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
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Time frame: up to 20 months
Response rate by RECIST 1.1 criteria
Time frame: up to 20 months
Response rate by GCIG CA125
Time frame: up to 20 months