Back to resultsA Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fluzoparib
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
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.
Sites / Locations
- Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fluzoparib+mFOLFIRINOX
Arm Description
Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy
Outcomes
Primary Outcome Measures
Number of participants with a dose limited toxicity
Number of participants with a dose limited toxicity
Maximum tolerated dose
Maximum tolerated dose
RP2D
Recommended Phase 2 Dose
R0 resection rate
R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
Secondary Outcome Measures
AEs
Incidence of adverse events and associated dose of Fluzoparib
Resection Rate
Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
MPR Rate
Major pathological response rate based on central review
Objective response rate
Objective response rate
Disease-free-survival
Disease-free-survival
Event-Free-Survival
Event-Free-Survival
Overall-Survival
Overall-Survival
Minimum concentration (Cmin)
Minimum observed plasma concentration for Fluzoparib
Full Information
NCT ID
NCT04425876
First Posted
June 4, 2020
Last Updated
December 30, 2020
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04425876
Brief Title
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluzoparib+mFOLFIRINOX
Arm Type
Experimental
Arm Description
Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Other Intervention Name(s)
SHR3162
Intervention Description
Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy
Primary Outcome Measure Information:
Title
Number of participants with a dose limited toxicity
Description
Number of participants with a dose limited toxicity
Time Frame
28 Days (first and second cycle)
Title
Maximum tolerated dose
Description
Maximum tolerated dose
Time Frame
Up to 8 months
Title
RP2D
Description
Recommended Phase 2 Dose
Time Frame
Up to 8 months
Title
R0 resection rate
Description
R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
AEs
Description
Incidence of adverse events and associated dose of Fluzoparib
Time Frame
From the first drug administration to within 30 days for the last drug dose
Title
Resection Rate
Description
Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
Time Frame
Up to 2 years
Title
MPR Rate
Description
Major pathological response rate based on central review
Time Frame
Up to 2 years
Title
Objective response rate
Description
Objective response rate
Time Frame
Up to 2 years
Title
Disease-free-survival
Description
Disease-free-survival
Time Frame
Up to 2 years
Title
Event-Free-Survival
Description
Event-Free-Survival
Time Frame
Up to 2 years
Title
Overall-Survival
Description
Overall-Survival
Time Frame
Up to 2 years
Title
Minimum concentration (Cmin)
Description
Minimum observed plasma concentration for Fluzoparib
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlei Jin, Ph.D
Phone
86-021-23511999
Email
jinchunlei@hrglobe.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boyong Shen, M.D.
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boyong Shen, M.D.
12. IPD Sharing Statement
Learn more about this trial
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer
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