drugset / Trial / NCT02742324
Trial Ruxolitinib and Peg-interferon Alpha-2a Combination in Patients With Primary Myelofibrosis RUXOPeg
NaSingle-groupOpen-labelTreatment
Summary
Phase 1/2, open-label, multi-center, trial, aiming at to identify the most efficacious dose combination that also satisfies certain safety requirements. It consists in a dose finding study to assess the safety of the combination of different doses of both ruxolitinib and peg-IFN alpha-2a, and a secondary randomized evaluation of the optimal doses found in the first part of the study to a total maximal number of 42 evaluable patients.
Timeline
- Start
- 2016-03
- Primary completion
- 2021-12-30
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PegIFN-alpha-2a | Protein / enzyme biologic | 45 ug | Subcutaneous |
| Subject | PegIFN-alpha-2a | Protein / enzyme biologic | 90 ug | Subcutaneous |
| Subject | PegIFN-alpha-2a | Protein / enzyme biologic | 135 ug | Subcutaneous |
| Subject | Ruxolitinib | Small molecule | 10 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 15 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 20 mg | Oral |