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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: Fluzoparib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintenance Fluzoparib monotherapy<br> | Drug: Fluzoparib<br>* Fluzoparib capsules po. 150 mg twice daily<br>* Other names: SHR3162;|
| Placebo Comparator: Maintenance placebo monotherapy<br> | Drug: Placebo<br>* Placebo capsules po. twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1 | Progression-Free-Survival | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR by BICR Using RECIST v1.1 | Objective Response Rate | up to 3 years | 
| DCR by BICR Using RECIST v1.1 | Disease Control Rate | up to 3 years | 
| DoR by BICR Using RECIST v1.1 | Duration of Response | up to 3 years | 
| PFS by Investigators Using RECIST v1.1 | Progression-Free-Survival | up to 3 years | 
| ORR by Investigators Using RECIST v1.1 | Objective Response Rate | up to 3 years | 
| DCR by Investigators Using RECIST v1.1 | Disease Control Rate | up to 3 years | 
| DoR by Investigators Using RECIST v1.1 | Duration of Response | up to 3 years | 
| OS | Overall-Survival | up to 3 years | 
| Number of participants with treatment-emergent adverse events | The number and proportion of subjects experiencing treatment-emergent adverse events (TEAE) | From the first drug administration to within 30 days for the last drug dose |