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

A Phase I Study to Assess the Tolerability, Safety and Efficacy of Fluzoparib in Combination With mFOLFIRINOX as Neoadjuvant and Adjuvant Therapy 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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Fluzoparib

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chunlei Jin, Ph.D; Phone Number: 86-021-23511999; Email: jinchunlei@hrglobe.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Boyong Shen, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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; Other Names: SHR3162

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Boyong Shen, M.D., Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: SHR3162-I-116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No