A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
- Conditions
- Relapsed Ovarian Cancer
- Interventions
- Drug: Fluzoparib+Apatinib
- Registration Number
- NCT04517357
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Safety Lead-in or Parallel， Fluzoparib+Apatinib Fluzoparib+Apatinib Participants will receive Fluzoparib-Apatinib combination until progression Exploratory cohort: Fluzoparib+Apatinib Fluzoparib+Apatinib Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression Fluzoparib monotherapy Fluzoparib Participants will receive Fluzoparib monotherapy until progression
- Primary Outcome Measures
Name Time Method (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
Name Time Method 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 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
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China