drugset / Trial / NCT06079346
A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.
Timeline
- Start
- 2024-05-01
- Primary completion
- 2026-06-01
- Completion
- 2027-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | trabedersen | Antisense oligonucleotide | — | Intravenous |
| Comparator | Irinotecan | Small molecule | 180 mg/m2 | — |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | — |