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Clinical Trial Summary

This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In Phase 3, JAKi treatment-naïve MF participants are enrolled in 2:1 ratio to receive the combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT04562389
Study type Interventional
Source Karyopharm Therapeutics Inc
Contact Karyopharm Medical Information
Phone (888) 209-9326
Status Recruiting
Phase Phase 3
Start date March 11, 2021
Completion date March 2028

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