drugset / Trial / NCT05371964
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis
NaSequentialOpen-labelTreatment
Summary
The purpose of the study is to identify the recommended Part 2 dose (R2PD) of imetelstat sodium in combination with ruxolitinib in participants with myelofibrosis (MF) in Part 1, and to evaluate the safety and preliminary clinical activity of the R2PD of imetelstat sodium in combination with ruxolitinib in participants with MF in Part 2.
Timeline
- Start
- 2022-05-04
- Primary completion
- 2027-02
- Completion
- 2028-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imetelstat | Oligonucleotide (other) | 4.7 mg/kg | Intravenous |
| Subject | Imetelstat | Oligonucleotide (other) | 6 mg/kg | Intravenous |
| Subject | Imetelstat | Oligonucleotide (other) | 7.5 mg/kg | Intravenous |
| Subject | Imetelstat | Oligonucleotide (other) | 9.4 mg/kg | Intravenous |
| Background | Ruxolitinib | Small molecule | — | Oral |