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NCT Number: NCT04562389

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Primary Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 18 years
  • A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF.
  • Active symptoms of MF as determined by presence of at least 2 symptoms using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
  • Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk.
  • Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (>=) 450 cubic centimeter (cm^3) .
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 2.

Exclusion criteria

  • More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
  • Previous treatment with JAK inhibitors for MF.
  • Previous treatment with selinexor or other XPO1 inhibitors.

Treatment and study plan

Selinexor

Drug

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

Other names: KPT-330

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.

Primary outcomes

  1. 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

  2. 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

    Time frame: At Week 24

  3. Phase 1: Maximum Tolerated Dose (MTD)

    Time frame: Approximately within the first cycle (28 days) of therapy

  4. Phase 1: Recommended Phase 2 Dose (RP2D)

    Time frame: Approximately within the first cycle (28 days) of therapy

  5. Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity

    Time frame: From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)

Secondary outcomes

  1. Phase 3: Overall survival (OS)

    Time frame: From Baseline up to EoS (approximately 48 months)

  2. Phase 3: Progression-free survival (PFS)

    Time frame: Time from randomization until disease progression or death, whichever occurs first (approximately 48 months)

Sponsors and collaborators

Lead sponsor

Karyopharm Therapeutics Inc

Industry

Registry information

Official study title

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

Acronym: SENTRY

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Sep 24, 2020
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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