Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Selinexor: Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.

Selinexor: Participants will receive a dose of 60 mg selinexor oral tablets QW.

Placebo: Participants will receive a matching placebo of selinexor oral tablets QW

Ruxolitinib: Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.

Study 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.

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (166)

+ 126 more sites — see the full list on the official registry below.

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