A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
NCT ID: NCT03509636
Last Updated: 2022-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
113 participants
INTERVENTIONAL
2018-04-04
2020-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Fluzoparib capsule
Fluzoparib
Fluzoparib capsule will be given twice daily orally
Interventions
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Fluzoparib
Fluzoparib capsule will be given twice daily orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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HR-FZPL-Ⅰb-OC
Identifier Type: -
Identifier Source: org_study_id
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