drugset / Trial / NCT03373877
Evaluation of Ruxolitinib in Combination With PU-H71 for Treatment of Myelofibrosis
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine Maximum Tolerated Dose (MTD). The second part of the study (Dose Confirmation) will confirm the recommended Phase 2 dose (RP2D) in an expanded population.
Timeline
- Start
- 2018-05-24
- Primary completion
- 2019-10-17
- Completion
- 2020-03-10
Outcome
Outcome not reported
Stopped: “Samus is focusing all of their efforts in myelofibrosis on the new oral formulation of PU-H71.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PU-H71 | Small molecule | 225 mg/m2 | Intravenous |
| Subject | PU-H71 | Small molecule | 300 mg/m2 | Intravenous |
| Subject | PU-H71 | Small molecule | 400 mg/m2 | Intravenous |
| Subject | PU-H71 | Small molecule | 600 mg/m2 | Intravenous |
| Background | Ruxolitinib | Small molecule | — | — |