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
Overview
- Phase
- Phase 2
- Intervention
- Fluzoparib+Apatinib
- Conditions
- Relapsed Ovarian Cancer
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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-
- •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.
Arms & Interventions
Safety Lead-in or Parallel， Fluzoparib+Apatinib
Participants will receive Fluzoparib-Apatinib combination until progression
Intervention: Fluzoparib+Apatinib
Fluzoparib monotherapy
Participants will receive Fluzoparib monotherapy until progression
Intervention: Fluzoparib
Exploratory cohort: Fluzoparib+Apatinib
Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression
Intervention: Fluzoparib+Apatinib
Outcomes
Primary Outcomes
(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
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
(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
- Response rate by RECIST 1.1 criteria(up to 20 months)
- Response rate by GCIG CA125(up to 20 months)
- AEs+SAEs(from the first drug administration to within 30 days for the last treatment dose)
- Progression free survival (PFS)(up to 20 months)
- Disease control rate (DCR)(up to 20 months)
- Duration of response (DoR)(up to 20 months)