Back to resultsA Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fluzoparib
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
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.
Sites / Locations
- Cancer Hospital Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Fluzoparib capsule
Outcomes
Primary Outcome Measures
ORR by RECIST v1.1
Objective response rate
Secondary Outcome Measures
DoR
Duration of response
PFS
Progression free survival
Response rate by GCIG CA-125
Response rate per GCIG CA-125
OS
Overall suvival
Incidence of adverse events, clinical laboratory abnormalities, and dose modifications
per CTC AE 4.03
Trough (Cmin) level of fluzoparib concentrations
Cssmin of fluzoparib concentrations
Full Information
NCT ID
NCT03509636
First Posted
February 25, 2018
Last Updated
June 30, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03509636
Brief Title
A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
July 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Fluzoparib capsule
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Other Intervention Name(s)
SHR-3162
Intervention Description
Fluzoparib capsule will be given twice daily orally
Primary Outcome Measure Information:
Title
ORR by RECIST v1.1
Description
Objective response rate
Time Frame
every 8 weeks (±7 days) of treatment
Secondary Outcome Measure Information:
Title
DoR
Description
Duration of response
Time Frame
study data collection expected to last for ~2 years
Title
PFS
Description
Progression free survival
Time Frame
expected to last for ~2 years
Title
Response rate by GCIG CA-125
Description
Response rate per GCIG CA-125
Time Frame
every 8 weeks (±7 days) of treatment expected to last for ~2 years
Title
OS
Description
Overall suvival
Time Frame
study data collection expected to last for ~2 years
Title
Incidence of adverse events, clinical laboratory abnormalities, and dose modifications
Description
per CTC AE 4.03
Time Frame
Every day starting with signing of consent until 30 days after discontinuation of treatment
Title
Trough (Cmin) level of fluzoparib concentrations
Description
Cssmin of fluzoparib concentrations
Time Frame
Cycle 1 to cycle 4(each cycle is 28 days)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
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