Stopped: drug supply issues
This phase Ib/II trial studies the side effects and best dose of pan fibroblast growth factor receptor (FGFR) kinase inhibitor BGJ398 when given together with fluorouracil, irinotecan hydrochloride and oxaliplatin (combination chemotherapy) in treating patients with untreated pancreatic cancer that has spread to another place in the body. Pan FGFR kinase inhibitor BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pan FGFR kinase inhibitor BGJ398 together with fluorouracil, irinotecan hydrochloride and oxaliplatin may be a better treatment for pancreatic cancer.
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Incidence of dose-limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase Ib)
Timeframe: Up to 28 days
Maximum tolerated dose (MTD) and recommended phase II dose of BGJ398 in combination with mFOLFIRINOX, defined as the dose with a probability of DLT of 0.30 graded according to the NCI CTCAE version 4.0 (Phase Ib)
Timeframe: 28 days
Overall survival (Phase II)
Timeframe: Time from the start of the study treatment until death, last follow-up or drop-out, assessed at 6 months