drugset / Trial / NCT03487016
First-line Therapy in Metastatic PDAC
RandomizedParallel-groupOpen-labelTreatment
Summary
The overarching hypothesis of this trial is that the NAPOLI regimen and alternating cycles of NAPOLI and mFOLFOX6 (seq-NAPOLI-FOLFOX) are superior to the current standard of care gemcitabine/nab-paclitaxel. Furthermore, we propose that the NAPOLI regimen and seq-NAPOLI-FOLFOX display favourable safety profiles and allow for longer first line treatment and higher rate of transition into the second line setting.
Timeline
- Start
- 2019-02-15
- Primary completion
- 2022-07-01
- Completion
- 2023-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Subject | nal-Iri | Unknown | 80 mg/m2 | Intravenous |