Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Myelofibrosis

In brief

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 facts

Study ID

NCT04562389

Run by

Karyopharm Therapeutics Inc

People needed

353

Starts

2021-03-11

Expected to finish

2028-03-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA - Satellite Site — Beverly Hills, California, United States
• City of Hope — Duarte, California, United States
• UCLA - Satellite Site — Encino, California, United States
• City of Hope - Irvine Lennar - Satellite — Irvine, California, United States
• UCLA — Los Angles, California, United States
• The Oncology Institute of Hope & Innovation — Pasadena, California, United States
• USOR - Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• Smilow Cancer Hospital - New Haven — New Haven, Connecticut, United States
• Georgetown Lombardi Comprehensive Center — Washington D.C., District of Columbia, United States
• Norton Cancer Institute - Saint Matthews — Louisville, Kentucky, United States
• Maryland Oncology Hematology-Satellite — Annapolis, Maryland, United States
• The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Maryland Oncology Hematology-Satellite — Brandywine, Maryland, United States
• Maryland Oncology Hematology — Columbia, Maryland, United States
• Maryland Oncology Hematology-Satellite — Rockville, Maryland, United States
• Maryland Oncology Hematology-Satellite — Silver Spring, Maryland, United States
• The Cancer & Hematology Centers -Satellite Site — Grand Rapids, Michigan, United States
• The Cancer & Hematology Centers of Muskegon — Norton Shores, Michigan, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Mount Sinai Health System — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke Cancer Institue — Durham, North Carolina, United States
• USOR - Oncology Hematology Care - Kenwood — Cincinnati, Ohio, United States
• Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States
• UAB Division of Hematology/Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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