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
1 other identifier
interventional
113
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 ovarian-cancer
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2018
CompletedStudy Start
First participant enrolled
April 4, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2020
CompletedJuly 1, 2022
June 1, 2022
1.4 years
February 25, 2018
June 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
ORR by RECIST v1.1
Objective response rate
every 8 weeks (±7 days) of treatment
Secondary Outcomes (6)
DoR
study data collection expected to last for ~2 years
PFS
expected to last for ~2 years
Response rate by GCIG CA-125
every 8 weeks (±7 days) of treatment expected to last for ~2 years
OS
study data collection expected to last for ~2 years
Incidence of adverse events, clinical laboratory abnormalities, and dose modifications
Every day starting with signing of consent until 30 days after discontinuation of treatment
- +1 more secondary outcomes
Study Arms (1)
Treatment
EXPERIMENTALFluzoparib capsule
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2018
First Posted
April 26, 2018
Study Start
April 4, 2018
Primary Completion
August 26, 2019
Study Completion
July 23, 2020
Last Updated
July 1, 2022
Record last verified: 2022-06