Trials / Active Not Recruiting
Active Not RecruitingNCT04562389
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 353 (actual)
- Sponsor
- Karyopharm Therapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a global, multicenter, 2-part 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 Phase 2 dose (RP2D) 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). Phase 3 (ongoing), double-blind, placebo-controlled part of the study comparing the efficacy and safety of combination therapy of selinexor + ruxolitinib with combination of placebo + ruxolitinib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selinexor | Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW. |
| DRUG | Selinexor | Participants will receive a dose of 60 mg selinexor oral tablets QW. |
| OTHER | Placebo | Participants will receive a matching placebo of selinexor oral tablets QW |
| DRUG | Ruxolitinib | Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID. |
Timeline
- Start date
- 2021-03-11
- Primary completion
- 2026-02-20
- Completion
- 2028-03-01
- First posted
- 2020-09-24
- Last updated
- 2026-04-09
Locations
166 sites across 20 countries: United States, Australia, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04562389. Inclusion in this directory is not an endorsement.