drugset / Trial / NCT05472259
A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
Phase 2
Recruiting
134 enrolled
Belgian Group of Digestive Oncology
University Hospital St Luc, Brussels · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy
Timeline
- Start
- 2022-05-25
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nanoliposomal Irinotecan | Unknown | 50 mg/m2 | — |
| Subject | Nanoliposomal Irinotecan | Unknown | 70 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 60 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |