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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
39
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Phase Ib:Number of Participants With a Dose Limited Toxicity
Number of Participants With a Dose Limited Toxicity
Time frame: Within 28 Days after The First Dose
Phase Ib:Maximum Tolerated Dose
Maximum Tolerated Dose
Time frame: Up to 8 months
Phase Ib:Recommended Phase 2 Dose
Recommended Phase 2 Dose
Time frame: Up to 2 years
Phase II:Objective Response Rate
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)
Adverse events evaluated by NCI CTCAE v5.0
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
Disease Control Rate
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)
Duration of Response
Duration of Response
Time frame: Up to 2 years
Progression-Free-Survival
Time from randomisation until the date of objective radiological disease progression according to RECIST v1.1 or death
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Time frame: Up to 2 years
Overall-Survival
Time from the date of randomization until death due to any cause
Time frame: Up to 2 years
Area under the curve (AUC)
Area under the plasma concentration time curve from 0 to 24 hours for Fluroparib
Time frame: 1 year
Maximum concentration (Cmax)
Maximum observed plasma concentration for Fluzoparib
Time frame: 1 year
Time to maximum concentration (Tmax)
Time to maximum plasma concentration for Fluzoparib
Time frame: 1 year