A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Maintenance Fluzoparib monotherapy
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Drug: Fluzoparib
Fluzoparib capsules po. 150 mg twice daily
Other Names:
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Placebo Comparator: Maintenance placebo monotherapy
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Drug: Placebo
Placebo capsules po. twice daily
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Outcome Measures
Primary Outcome Measures
- PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1 [up to 3 years]
Progression-Free-Survival
Secondary Outcome Measures
- ORR by BICR Using RECIST v1.1 [up to 3 years]
Objective Response Rate
- DCR by BICR Using RECIST v1.1 [up to 3 years]
Disease Control Rate
- 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
- OS [up to 3 years]
Overall-Survival
- 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)
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Aged ≥ 18 years.
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Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
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Expected survival ≥ 3 months.
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Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
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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.
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Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT or MRI.
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Documented mutation in germline BRCA1/2 or PALB2 that is predicted to be deleterious or suspected deleterious.
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Adequate organ performance based on laboratory blood tests.
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Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
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Ability to understand and the willingness to sign a written informed consent document.
Major Exclusion Criteria:
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Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
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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.
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Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks.
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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.
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Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
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Patients with myelodysplastic syndrome/acute myeloid leukaemia.
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Known active hepatitis B or C infection.
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History of immunodeficiency (including HIV infection) or organ transplantation.
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Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Anhui Provincial Hospital | Hefei | Anhui | China | 230001 |
2 | Beijing Cancer Hospital | Beijing | Beijing | China | |
3 | Beijing Cancer Hospital | Beijing | Beijing | China | |
4 | Chinese PLA General Hospital | Beijing | Beijing | China | |
5 | Peking Union Medical College Hospital | Beijing | Beijing | China | |
6 | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing | China | |
7 | Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China | |
8 | Sun Yat-Sen Memorial Hospital | Guangzhou | Guangdong | China | |
9 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | |
10 | The 3rd Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China | |
11 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | |
12 | Hubei Cancer Hospital | Wuhan | Hubei | China | |
13 | Jiangsu Cancer Hospital | Nanjing | Jiangsu | China | 210009 |
14 | Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China | |
15 | Shandong Cancer Hospital and Institute | Jinan | Shandon | China | |
16 | Changhai Hospital | Shanghai | Shanghai | China | |
17 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | |
18 | Huashan Hospital, Fudan University | Shanghai | Shanghai | China | |
19 | Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai | China | |
20 | Xinhua Hospital Affilited to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | |
21 | Sichuan Cancer Hospital Institute | Chengdu | Sichuan | China | |
22 | West China Hospital | Chengdu | Sichuan | China | |
23 | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin | China | |
24 | The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
- Principal Investigator: Yupei Zhao, Ph.D, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR3162-III-304