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

NCT04425876 | Unknown Phase 1

• 1 other identifier: SHR3162-I-116
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• AEs

  From the first drug administration to within 30 days for the last drug dose

• Resection Rate

  Up to 2 years

• MPR Rate

  Up to 2 years

• Objective response rate

  Up to 2 years

• Disease-free-survival

  Up to 2 years

Study Arms (1)

Fluzoparib+mFOLFIRINOX

EXPERIMENTAL

Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy

Drug: Fluzoparib

Interventions

Fluzoparib DRUG

Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy

Also known as: SHR3162

Fluzoparib+mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

fluzoparib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Boyong Shen, M.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunlei Jin, Ph.D

CONTACT

86-021-23511999; jinchunlei@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 11, 2020
• Study Start: December 17, 2020
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

CN (1)