A Study Of Fluzoparib In Combination With MFOLFIRINOX In Patients With Advanced Pancreatic Cancer

Study Overview

A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer

The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer, and establish the maximum tolerated dose and recommended phase II dose of the combination; and b) assess the efficacy of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer.

N/A

Advanced Pancreatic Cancer

DRUG: Fluzoparib
DRUG: Fluzoparib placebo
DRUG: mFOLFIRINOX

SHR3162-Ib/II-112

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 2020-01-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-14
First Submitted that Met QC Criteria 2020-01-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-16
First Posted (ACTUAL) 2020-01-14	Results First Posted N/A	Last Verified 2024-08

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: Fluzoparib+mFOLFIRINOX Fluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy	DRUG: Fluzoparib PARP DRUG: mFOLFIRINOX mFOLFIRINOX
PLACEBO_COMPARATOR: Placebo+mFOLFIRINOX Placebo+mFOLFIRINOX followed by placebo maintenance monotherapy	DRUG: Fluzoparib placebo Placebo DRUG: mFOLFIRINOX mFOLFIRINOX

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Fluzoparib+mFOLFIRINOX

Fluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy

DRUG: Fluzoparib

PARP

DRUG: mFOLFIRINOX

mFOLFIRINOX

PLACEBO_COMPARATOR: Placebo+mFOLFIRINOX

Placebo+mFOLFIRINOX followed by placebo maintenance monotherapy

DRUG: Fluzoparib placebo

Placebo

DRUG: mFOLFIRINOX

mFOLFIRINOX

Primary Outcome Measures	Measure Description	Time Frame
Phase Ib：Number of Participants With a Dose Limited Toxicity	Number of Participants With a Dose Limited Toxicity	Within 28 Days after The First Dose
Phase Ib：Maximum Tolerated Dose	Maximum Tolerated Dose	Up to 8 months
Phase Ib：Recommended Phase 2 Dose	Recommended Phase 2 Dose	Up to 2 years
Phase II：Objective Response Rate	Objective response rate according to RECIST 1.1	From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)

Secondary Outcome Measures	Measure Description	Time Frame
Adverse events evaluated by NCI CTCAE v5.0	Incidence of adverse events and associated dose of Fluzoparib	From the first drug administration to within 30 days for the last drug dose
Disease Control Rate	Disease control rate according to RECIST 1.1	From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)
Duration of Response	Duration of Response	Up to 2 years
Progression-Free-Survival	Time from randomisation until the date of objective radiological disease progression according to RECIST v1.1 or death	Up to 2 years
Overall-Survival	Time from the date of randomization until death due to any cause	Up to 2 years
Area under the curve (AUC)	Area under the plasma concentration time curve from 0 to 24 hours for Fluroparib	1 year
Maximum concentration (Cmax)	Maximum observed plasma concentration for Fluzoparib	1 year
Time to maximum concentration (Tmax)	Time to maximum plasma concentration for Fluzoparib	1 year

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 ≥ 6 months.
Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma.
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.
Presence of at least of one measurable lesion in agreement to RECIST criteria.
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.

Patients who have received any chemotherapy for the treatment of pancreatic cancer prior to entering the study.
Previous treatment with any poly ADP-ribose polymerase (PARP) inhibitor.
Patients who have had radiotherapy or participated in another clinical trial with any investigational agents within 28 days of enrolment (Day 1 visit).
History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan, 5-Fluorouracil or other agents used in the study.
Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks of enrolment (Day 1 visit).
Patients with known or suspected brain metastasis.
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.
Patients with second primary cancer except curatively treated in-situ cancer or slowly progressing malignancy.
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: Xianjun Yu, M.D., Fudan University

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

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Resources

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Clinical Trial Record