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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 (SENTRY)
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.
Details
| Lead sponsor | Karyopharm Therapeutics Inc |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 353 |
| Start date | 2021-03-11 |
| Completion | 2028-03 |
Conditions
- Myelofibrosis
Interventions
- Selinexor
- Selinexor
- Placebo
- Ruxolitinib
Primary outcomes
- Phase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24 Measured by the Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan — At Week 24
- Phase 3: Absolute mean change in TSS (Abs-TSS) from baseline to Week 24 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 — At Week 24
- Phase 1: Maximum Tolerated Dose (MTD) — Approximately within the first cycle (28 days) of therapy
- Phase 1: Recommended Phase 2 Dose (RP2D) — Approximately within the first cycle (28 days) of therapy
- Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity — From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
Countries
United States, Australia, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom