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.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |