Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Conditions

• Myelofibrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
  Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
• Selinexor — DRUG
  Participants will receive a dose of 60 mg selinexor oral tablets QW.
• Placebo — OTHER
  Participants will receive a matching placebo of selinexor oral tablets QW
• Ruxolitinib — DRUG
  Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.

Study Details

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.

Key Dates

Start date

Mar 11, 2021

Status verified

Apr 2026

Primary completion

Feb 20, 2026

Completion

Mar 31, 2028

Study Design

Enrollment

353 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID
  Participants with MF will receive a dose of 40 milligrams (mg) selinexor oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib twice a day (BID) based on the participants baseline platelet count.
• Experimental: Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID
  Participants with MF will receive a dose of 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
• Experimental: Phase 1b: Selinexor and Ruxolitinib BID
  Participants with MF will receive a dose of 40 or 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
• Experimental: Phase 3: Selinexor 60 mg + Ruxolitinib BID
  Participants with MF will receive a fixed starting dose of 60 mg selinexor (RD) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
• Active Comparator: Phase 3: Placebo + Ruxolitinib BID
  Participants with MF will receive a matching placebo of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.

Primary Outcome Measure

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 [ Time Frame: At Week 24 ]

Locations (36)

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