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

A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated 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.

N/A

Metastatic Pancreatic Cancer

DRUG: Fluzoparib
DRUG: Placebo

SHR3162-III-304

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-03-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-27
First Submitted that Met QC Criteria 2020-03-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-28
First Posted (ACTUAL) 2020-03-09	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Maintenance Fluzoparib monotherapy	DRUG: Fluzoparib Fluzoparib capsules po. 150 mg twice daily
PLACEBO_COMPARATOR: Maintenance placebo monotherapy	DRUG: Placebo Placebo capsules po. twice daily

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Maintenance Fluzoparib monotherapy

DRUG: Fluzoparib

Fluzoparib capsules po. 150 mg twice daily

PLACEBO_COMPARATOR: Maintenance placebo monotherapy

DRUG: Placebo

Placebo capsules po. twice daily

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Yupei Zhao, Ph.D, Peking Union Medical College Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record