Clinical trial · Interventional
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
NCT03509636CI-TRIAL-00059449completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluzoparib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Fluzoparib capsule
- interventionNames
- Drug: Fluzoparib
Primary outcomes (1)
- measure
- ORR by RECIST v1.1
- timeFrame
- every 8 weeks (±7 days) of treatment
- description
- Objective response rate
Secondary outcomes (6)
- measure
- DoR
- timeFrame
- study data collection expected to last for ~2 years
- description
- Duration of response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of high grade serous or Grade 2/3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer； * Confirmed documented BRCA1/2 mutation; * Received 2\~4 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen； * Relapsed/progressive disease as confirmed by radiologic assessment； * Have measurable disease as defined by RECIST v1.1. Exclusion Criteria: * Any previous treatment with a PARP inhibitor; * Patient with any other malignancy which has been active or treated within the previous 5 years; * Patients with symptomatic uncontrolled brain metastases; * Patients unable to swallow orally administered medication.
References
Publications (0)
Data not yet available
No reference posted for this study.