A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
- Registration Number
- NCT04300114
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The study is being conducted to evaluate the tolerability, safety and efficacy of maintenance Fluzoparib monotherapy in patients with gBRCA/PALB2 mutated metastatic pancreatic cancer whose disease has not progressed on first line platinum based chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- Aged ≥ 18 years.
- 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.
Major
- Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maintenance placebo monotherapy Placebo - Maintenance Fluzoparib monotherapy Fluzoparib -
- Primary Outcome Measures
Name Time Method PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1 up to 3 years Progression-Free-Survival
- Secondary Outcome Measures
Name Time Method DCR by BICR Using RECIST v1.1 up to 3 years Disease Control Rate
ORR by BICR Using RECIST v1.1 up to 3 years Objective Response Rate
OS up to 3 years Overall-Survival
DoR by BICR Using RECIST v1.1 up to 3 years Duration of Response
PFS by Investigators Using RECIST v1.1 up to 3 years Progression-Free-Survival
ORR by Investigators Using RECIST v1.1 up to 3 years Objective Response Rate
DCR by Investigators Using RECIST v1.1 up to 3 years Disease Control Rate
DoR by Investigators Using RECIST v1.1 up to 3 years Duration of Response
Number of participants with treatment-emergent adverse events From the first drug administration to within 30 days for the last drug dose The number and proportion of subjects experiencing treatment-emergent adverse events (TEAE)
Trial Locations
- Locations (23)
West China Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Sun Yat-Sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The 3rd Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Sichuan Cancer Hospital Institute
🇨🇳Chengdu, Sichuan, China
Xinhua Hospital Affilited to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Shandong Cancer Hospital and Institute
🇨🇳Jinan, Shandon, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China