drugset / Trial / NCT06897644

Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.

NCT06897644 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

PANThEON is a randomized, open-label, multicenter phase III trial aimed at comparing the switch maintenance with gemcitabine plus nab-paclitaxel (ARM B) versus mFOLFIRINOX continuation (ARM A) in terms of overall survival (OS) in patients with unresectable LAD or mPDAC without disease progression following 3 months of induction mFOLFIRINOX triplet chemotherapy.

Timeline

Start
2025-03-27
Primary completion
2029-01-01
Completion
2030-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 —
Comparator Irinotecan Small molecule 150 mg/m2 Intravenous
Comparator Leucovorin Small molecule 200 mg/m2 —
Comparator Leucovorin Small molecule 400 mg/m2 —
Subject Nab-paclitaxel Small molecule 125 mg/m2 —
Comparator Oxaliplatin Small molecule 85 mg/m2 Intravenous
Comparator fluorouracil Small molecule 2400 mg/m2 —