A Study to Evaluate Safety and Efficacy of Selinexor in Combination With Ruxolitinib in Participants With Myelofibrosis
Status:
Recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
This is a global, Phase 1/2, multicenter, open-label study to evaluate the safety and
efficacy of selinexor plus ruxolitinib in treatment naïve myelofibrosis (MF) participants.
The study will be conducted in two phases: Phase 1a/1b and Phase 2. The Phase 1a of the study
will be dose escalation (non-randomized dose finding study) to determine the maximum
tolerated dose [MTD], recommended Phase 2 dose (RP2D), and evaluate safety and preliminary
efficacy and will follow a standard 3+3 design. The Phase 1b of the study will be dose
expansion (non-randomized efficacy exploration) at the determined RP2D to further assess the
safety and preliminary efficacy at this dose level. The Phase 2 (randomized efficacy
exploration) of the study will include MF participants who are treatment naïve randomized 1:1
to receive the combination therapy of selinexor and ruxolitinib versus (vs) ruxolitinib
monotherapy.