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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04425876
• Other study ID #: SHR3162-I-116
• Status: Recruiting
• Phase: Phase 1
• Start date: December 17, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Chunlei Jin, Ph.D
• Phone: 86-021-23511999
• Email: jinchunlei[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: September 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Fluzoparib
Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a dose limited toxicity	Number of participants with a dose limited toxicity	28 Days (first and second cycle)
Primary	Maximum tolerated dose	Maximum tolerated dose	Up to 8 months
Primary	RP2D	Recommended Phase 2 Dose	Up to 8 months
Primary	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	AEs	Incidence of adverse events and associated dose of Fluzoparib	From the first drug administration to within 30 days for the last drug dose
Secondary	Resection Rate	Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer	Up to 2 years
Secondary	MPR Rate	Major pathological response rate based on central review	Up to 2 years
Secondary	Objective response rate	Objective response rate	Up to 2 years
Secondary	Disease-free-survival	Disease-free-survival	Up to 2 years
Secondary	Event-Free-Survival	Event-Free-Survival	Up to 2 years
Secondary	Overall-Survival	Overall-Survival	Up to 2 years
Secondary	Minimum concentration (Cmin)	Minimum observed plasma concentration for Fluzoparib	Up to 2 years