A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
NCT ID: NCT04300114
Last Updated: 2024-03-28
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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TERMINATED
PHASE3
5 participants
INTERVENTIONAL
2020-08-19
2022-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Maintenance Fluzoparib monotherapy
Fluzoparib
Fluzoparib capsules po. 150 mg twice daily
Maintenance placebo monotherapy
Placebo
Placebo capsules po. twice daily
Interventions
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Fluzoparib
Fluzoparib capsules po. 150 mg twice daily
Placebo
Placebo capsules po. twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
* Expected survival ≥ 3 months.
* Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
* Patients who have received a minimum of 16 weeks of continuous platinum treatment for metastatic disease and have no evidence of progression based on investigator's opinion.
* Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT or MRI.
* Documented mutation in germline BRCA1/2 or PALB2 that is predicted to be deleterious or suspected deleterious.
* Adequate organ performance based on laboratory blood tests.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* Patients who have had radiotherapy within 2 weeks or participated in another clinical trial with any investigational agents within 2 weeks prior to study screening.
* Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks.
* Significant cardiovascular disease such as New York Heart Associate Class III/IV, cardiac failure, myocardial infarction, unstable arrhythmia, or evidence of ischemia on ECG within 6 months prior to enrolment.
* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
* Patients with myelodysplastic syndrome/acute myeloid leukaemia.
* Known active hepatitis B or C infection.
* History of immunodeficiency (including HIV infection) or organ transplantation.
* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yupei Zhao, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The 3rd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Shandong Cancer Hospital and Institute
Jinan, Shandon, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affilited to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital Institute
Chengdu, Sichuan, China
West China Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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SHR3162-III-304
Identifier Type: -
Identifier Source: org_study_id
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