A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer
- Conditions
- Advanced Pancreatic Cancer
- Interventions
- Registration Number
- NCT04228601
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluzoparib+mFOLFIRINOX Fluzoparib Fluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy Fluzoparib+mFOLFIRINOX mFOLFIRINOX Fluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy Placebo+mFOLFIRINOX Fluzoparib placebo Placebo+mFOLFIRINOX followed by placebo maintenance monotherapy Placebo+mFOLFIRINOX mFOLFIRINOX Placebo+mFOLFIRINOX followed by placebo maintenance monotherapy
- Primary Outcome Measures
Name Time Method Phase Ib：Number of Participants With a Dose Limited Toxicity Within 28 Days after The First Dose Number of Participants With a Dose Limited Toxicity
Phase Ib：Maximum Tolerated Dose Up to 8 months Maximum Tolerated Dose
Phase Ib：Recommended Phase 2 Dose Up to 2 years Recommended Phase 2 Dose
Phase II：Objective Response Rate From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months) Objective response rate according to RECIST 1.1
- Secondary Outcome Measures
Name Time Method Progression-Free-Survival Up to 2 years Time from randomisation until the date of objective radiological disease progression according to RECIST v1.1 or death
Duration of Response Up to 2 years Duration of Response
Overall-Survival Up to 2 years Time from the date of randomization until death due to any cause
Maximum concentration (Cmax) 1 year Maximum observed plasma concentration for Fluzoparib
Time to maximum concentration (Tmax) 1 year Time to maximum plasma concentration for Fluzoparib
Adverse events evaluated by NCI CTCAE v5.0 From the first drug administration to within 30 days for the last drug dose Incidence of adverse events and associated dose of Fluzoparib
Disease Control Rate From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months) Disease control rate according to RECIST 1.1
Area under the curve (AUC) 1 year Area under the plasma concentration time curve from 0 to 24 hours for Fluroparib
Trial Locations
- Locations (2)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China