Trials / Completed
CompletedNCT03509636
A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
An Open-Label Study to Assess the Efficacy And Safety of Poly(ADP-ribose) Polymerase Inhibitor Fluzoparib（SHR3162）in Patients With Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer and BRCA1/2 Mutation
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer.
Detailed description
Fluzoparib (SHR-3162) is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) 1/2 being developed for treatment of BRCA1/2-mutant solid tumor. The tolerability, safety and PK of fluzoparib has been evaluated in Phase 1 study. An oral formulation is the focus of current development efforts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluzoparib | Fluzoparib capsule will be given twice daily orally |
Timeline
- Start date
- 2018-04-04
- Primary completion
- 2019-08-26
- Completion
- 2020-07-23
- First posted
- 2018-04-26
- Last updated
- 2022-07-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03509636. Inclusion in this directory is not an endorsement.