Medical University of South Carolina
This is a single-center, open-label, randomized Phase 2 trial to evaluate the efficacy of NALIRIFOX (Arm 1) vs mGAP (Arm 2) in previously untreated patients with locally advanced (unresectable) and metastatic pancreatic ductal adenocarcinoma (PDAC).
Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies in the United States and is a leading cause of cancer-related deaths. In the metastatic setting, treatment consists of systemic chemotherapy in hopes of palliating symptoms and prolonging survival. However, prognosis remains very poor, and patients will invariably succumb to disease-related complications. Therefore, there is a critical need to identify new first-line systemic therapeutic options in hopes of improving clinical outcomes in PDAC. FOLFIRINOX (leucovorin, 5-flurouracil, irinotecan, oxaliplatin) bec…
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥18 years * For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method during study participation and for an additional 9 months after the end of the last dose of study medication administration * Female patients including WOCBP must test negative for pregnancy at the time of screening based on a urine or…
50 mg/m2 will be administered on Day 1 of a 2-week cycle
60 mg/m2 will be administered on Day 1 of a 2-week cycle
5-fluorouracil (2400 mg/m2 over 46 hours) will begin administration on Day 1 of a 2-week cycle
400 mg/m2 will be administered on Day 1 of a 2-week cycle
1000 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
125 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
25 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
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