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

Study Overview

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

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

N/A

Pancreatic Cancer

DRUG: Fluzoparib

SHR3162-I-116

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 2020-06-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-12-30
First Submitted that Met QC Criteria 2020-06-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-12-31
First Posted (ACTUAL) 2020-06-11	Results First Posted N/A	Last Verified 2020-12

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:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Fluzoparib+mFOLFIRINOX Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy	DRUG: Fluzoparib Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Fluzoparib+mFOLFIRINOX

Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy

DRUG: Fluzoparib

Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy

Primary Outcome Measures	Measure Description	Time Frame
Number of participants with a dose limited toxicity	Number of participants with a dose limited toxicity	28 Days (first and second cycle)
Maximum tolerated dose	Maximum tolerated dose	Up to 8 months
RP2D	Recommended Phase 2 Dose	Up to 8 months
R0 resection rate	R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer	Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
AEs	Incidence of adverse events and associated dose of Fluzoparib	From the first drug administration to within 30 days for the last drug dose
Resection Rate	Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer	Up to 2 years
MPR Rate	Major pathological response rate based on central review	Up to 2 years
Objective response rate	Objective response rate	Up to 2 years
Disease-free-survival	Disease-free-survival	Up to 2 years
Event-Free-Survival	Event-Free-Survival	Up to 2 years
Overall-Survival	Overall-Survival	Up to 2 years
Minimum concentration (Cmin)	Minimum observed plasma concentration for Fluzoparib	Up to 2 years

Contacts and Locations

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

Study Contact

Name: Chunlei Jin, Ph.D

Phone Number: 86-021-23511999

Email: jinchunlei@hrglobe.cn

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 18-79 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
Expected survival ≥ 6 months.
Histologically or cytologically confirmed pancreas adenocarcinoma.
Resectable or borderline resectable pancreatic cancer.
Adequate organ performance based on laboratory blood tests.
Presence of at least of one measurable lesion in agreement to RECIST criteria.
Ability to understand and the willingness to receive a needle biopsy.
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 had any chemotherapy or radiotherapy prior to entering the study.
Patients with metastasis disease.
Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
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.
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: Boyong Shen, M.D., Ruijin 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

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Resources

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Clinical Trial Record