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Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
NCT04562389 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Selinexor
- DRUG Ruxolitinib
Study Locations (20)
California
- UCLA - Satellite Site — Beverly Hills
- City of Hope — Duarte
- UCLA - Satellite Site — Encino
- City of Hope - Irvine Lennar - Satellite — Irvine
- UCLA — Los Angles
- The Oncology Institute of Hope & Innovation — Pasadena
Maryland
- Maryland Oncology Hematology-Satellite — Annapolis
- The Sidney Kimmel Comprehensive Cancer Center — Baltimore
- Maryland Oncology Hematology-Satellite — Brandywine
- Maryland Oncology Hematology — Columbia
- Maryland Oncology Hematology-Satellite — Rockville
- Maryland Oncology Hematology-Satellite — Silver Spring
Michigan
- The Cancer & Hematology Centers -Satellite Site — Grand Rapids
- The Cancer & Hematology Centers of Muskegon — Norton Shores
Alabama
- UAB Division of Hematology/Oncology — Birmingham
Colorado
- USOR - Rocky Mountain Cancer Centers - Aurora — Aurora
Connecticut
- Smilow Cancer Hospital - New Haven — New Haven
District of Columbia
- Georgetown Lombardi Comprehensive Center — Washington D.C.
Kentucky
- Norton Cancer Institute - Saint Matthews — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2021-03-11 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04562389
The ClinicalTrials.gov registry entry for NCT04562389 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Karyopharm Therapeutics, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myelofibrosis appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04562389 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Maryland, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04562389 about?
NCT04562389 is a clinical study titled "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 compl...
What is the current status of trial NCT04562389?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2021-03-11. Estimated completion is 2028-03.
What conditions does trial NCT04562389 study?
This clinical trial studies the following conditions: Myelofibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04562389?
The interventions under investigation include: Placebo (OTHER), Selinexor (DRUG), Ruxolitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04562389?
This trial is sponsored by Karyopharm Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04562389 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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