NCT05371964

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis

An Open Label, Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Patients With Myelofibrosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Geron Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Imetelstat sodium	Imetelstat sodium will be administered as intravenous (IV) every 28 days.
DRUG	Ruxolitinib	Ruxolitinib will be administered, orally (PO), twice daily (BID) in cohort B as the standard of care per local prescribing guidelines.

Timeline

• Start date: 2022-05-04
• Primary completion: 2027-02-01
• Completion: 2028-08-01
• First posted: 2022-05-12
• Last updated: 2026-01-06

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study