A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Key Inclusion Criteria:

• 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 Criteria:

• 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.