drugset / Trial / NCT04469556
Pancreatic Adenocarcinoma Signature Stratification for Treatment
Phase 2
Completed
150 enrolled
University Health Network, Toronto
Cold Spring Harbor Laboratory · collabDana-Farber Cancer Institute · collabJohns Hopkins University · collabMemorial Sloan Kettering Cancer Center · collabOntario Institute for Cancer Research · collabStand Up To Cancer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized multicentre phase II trial with a large translational component. The trial will evaluate the two standard chemotherapy regimens: modified folfirinox (mFFX) and gemcitabine/nab-paclitaxel (GA), in patients with untreated metastatic pancreatic ductal adenocarcinoma. Integrated into this phase II trial are a number of laboratory components including molecular profiling, patient derived organoid establishment, and drug testing sensitivity and other biomarkers.
Timeline
- Start
- 2020-10-14
- Primary completion
- 2025-03-05
- Completion
- 2025-03-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 5-fluouracil | Unknown | — | Intravenous |
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Comparator | Irinotecan | Small molecule | — | Intravenous |
| Comparator | Leucovorin | Small molecule | — | Intravenous |
| Comparator | Oxaliplatin | Small molecule | — | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | Intravenous |