Back to resultsA Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer
Primary Purpose
Advanced Pancreatic Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fluzoparib
Fluzoparib placebo
mFOLFIRINOX
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Aged ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Expected survival ≥ 6 months.
- Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma.
- Documented mutation in germline BRCA1/2 or PALB2 that is predicted to be deleterious or suspected deleterious.
- Adequate organ performance based on laboratory blood tests.
- Presence of at least of one measurable lesion in agreement to RECIST criteria.
- 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 received any chemotherapy for the treatment of pancreatic cancer prior to entering the study.
- Previous treatment with any poly ADP-ribose polymerase (PARP) inhibitor.
- Patients who have had radiotherapy or participated in another clinical trial with any investigational agents within 28 days of enrolment (Day 1 visit).
- 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 of enrolment (Day 1 visit).
- Patients with known or suspected brain metastasis.
- 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
- Fudan University Shanghai Cancer CenterRecruiting
- Zhejiang Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fluzoparib+mFOLFIRINOX
Placebo+mFOLFIRINOX
Arm Description
Fluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy
Placebo+mFOLFIRINOX followed by placebo maintenance 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
Objective Response Rate
Objective response rate according to RECIST 1.1
Secondary Outcome Measures
Adverse events evaluated by NCI CTCAE v5.0
Incidence of adverse events and associated dose of Fluzoparib
Disease Control Rate
Disease control rate according to RECIST 1.1
Duration of Response
Duration of Response
Progression-Free-Survival
Time from randomisation until the date of objective radiological disease progression according to RECIST v1.1 or death
Overall-Survival
Time from the date of randomization until death due to any cause
Area under the curve (AUC)
Area under the plasma concentration time curve from 0 to 24 hours for Fluroparib
Maximum concentration (Cmax)
Maximum observed plasma concentration for Fluzoparib
Time to maximum concentration (Tmax)
Time to maximum plasma concentration for Fluzoparib
Full Information
NCT ID
NCT04228601
First Posted
January 9, 2020
Last Updated
August 9, 2020
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04228601
Brief Title
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer
Official Title
A Phase Ib/II Study to Assess the Tolerability, Safety and Efficacy of Fluzoparib in Combination With mFOLFIRINOX Followed by Fluzoparib Maintenance Monotherapy in Patients With Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
February 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 mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer, and establish the maximum tolerated dose and recommended phase II dose of the combination; and b) assess the efficacy of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluzoparib+mFOLFIRINOX
Arm Type
Experimental
Arm Description
Fluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy
Arm Title
Placebo+mFOLFIRINOX
Arm Type
Placebo Comparator
Arm Description
Placebo+mFOLFIRINOX followed by placebo maintenance monotherapy
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Other Intervention Name(s)
SHR3162
Intervention Description
PARP
Intervention Type
Drug
Intervention Name(s)
Fluzoparib placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
mFOLFIRINOX
Intervention Description
mFOLFIRINOX
Primary Outcome Measure Information:
Title
Number of Participants With a Dose Limited Toxicity
Description
Number of Participants With a Dose Limited Toxicity
Time Frame
Within 28 Days after The First Dose
Title
Maximum Tolerated Dose
Description
Maximum Tolerated Dose
Time Frame
Time Frame: Up to 8 months
Title
Objective Response Rate
Description
Objective response rate according to RECIST 1.1
Time Frame
From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)
Secondary Outcome Measure Information:
Title
Adverse events evaluated by NCI CTCAE v5.0
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
Disease Control Rate
Description
Disease control rate according to RECIST 1.1
Time Frame
From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)
Title
Duration of Response
Description
Duration of Response
Time Frame
Up to 2 years
Title
Progression-Free-Survival
Description
Time from randomisation until the date of objective radiological disease progression according to RECIST v1.1 or death
Time Frame
Up to 2 years
Title
Overall-Survival
Description
Time from the date of randomization until death due to any cause
Time Frame
Up to 2 years
Title
Area under the curve (AUC)
Description
Area under the plasma concentration time curve from 0 to 24 hours for Fluroparib
Time Frame
1 year
Title
Maximum concentration (Cmax)
Description
Maximum observed plasma concentration for Fluzoparib
Time Frame
1 year
Title
Time to maximum concentration (Tmax)
Description
Time to maximum plasma concentration for Fluzoparib
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
Expected survival ≥ 6 months.
Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma.
Documented mutation in germline BRCA1/2 or PALB2 that is predicted to be deleterious or suspected deleterious.
Adequate organ performance based on laboratory blood tests.
Presence of at least of one measurable lesion in agreement to RECIST criteria.
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 received any chemotherapy for the treatment of pancreatic cancer prior to entering the study.
Previous treatment with any poly ADP-ribose polymerase (PARP) inhibitor.
Patients who have had radiotherapy or participated in another clinical trial with any investigational agents within 28 days of enrolment (Day 1 visit).
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 of enrolment (Day 1 visit).
Patients with known or suspected brain metastasis.
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
Xianjun Yu, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianjun Yu, M.D.
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiping Mou, M.D.
12. IPD Sharing Statement
Learn more about this trial
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer
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