Phase 3Active, not recruiting
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis (SENTRY)
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
- Sponsor
- Karyopharm Therapeutics Inc (Industry)
- Enrolment
- 353 enrolled
- Conditions
- Myelofibrosis
- Interventions
- Selinexor; Selinexor; Placebo; Ruxolitinib
- Ages
- adults, older adults
- Registry
- NCT04562389, CTIS2023-506139-13-00, EUCTR2020-003883-19
Full record on ClinicalTrials.gov
From the registry
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.
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
- 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
- Phase 1: Maximum Tolerated Dose (MTD)
- Phase 1: Recommended Phase 2 Dose (RP2D)
History
Study completion expected
Last registry update
Primary completion
Started
Registered