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

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Fluzoparib Monotherapy in Patients With gBRCA/PALB2 Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

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.

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.