Status:
TERMINATED
A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04300114
Start Date
August 19 2020
End Date
February 18 2022
Last Update
March 28 2024
Active Locations (23)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
3
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China