Ovarian Cancer
Conditions
Brief 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.
Interventions
DRUGFluzoparib
Fluzoparib capsule will be given twice daily orally
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR by RECIST v1.1 | every 8 weeks (±7 days) of treatment | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | expected to last for ~2 years | Progression free survival |
| Response rate by GCIG CA-125 | every 8 weeks (±7 days) of treatment expected to last for ~2 years | Response rate per GCIG CA-125 |
| DoR | study data collection expected to last for ~2 years | Duration of response |
| Incidence of adverse events, clinical laboratory abnormalities, and dose modifications | Every day starting with signing of consent until 30 days after discontinuation of treatment | per CTC AE 4.03 |
| Trough (Cmin) level of fluzoparib concentrations | Cycle 1 to cycle 4(each cycle is 28 days) | Cssmin of fluzoparib concentrations |
| OS | study data collection expected to last for ~2 years | Overall suvival |
Countries
China
Outcome results
None listed