drugset / Trial / NCT07076212

Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma

NCT07076212

Phase 2 Recruiting 52 enrolled Medical University of South Carolina
RandomizedSequentialOpen-labelTreatment

Summary

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).

Timeline

Start
2026-04-02
Primary completion
2028-05
Completion
2029-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2
Subject Gemcitabine Small molecule 1000 mg/m2
Subject Irinotecan Small molecule 50 mg/m2
Subject Leucovorin Small molecule 400 mg/m2
Subject Oxaliplatin Small molecule 60 mg/m2
Subject Paclitaxel Small molecule 125 mg/m2
Subject fluorouracil Small molecule 2400 mg/m2