A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients
NCT03075462 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2022-07-01
Summary
Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.
Conditions
Interventions
- DRUG
-
Fluzoparib
Fluzoparib either at 40,60,80mg twice daily,capsule oral.
- DRUG
-
Apatinib
Apatinib at 250mg once daily, tablet oral
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
collaborator OTHER -
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-09
- Primary Completion
- 2021-08-22
- Completion
- 2021-12-13
Countries
- China
Study Locations
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