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NCT04562389 · ClinicalTrials.gov registry record · Phase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
A Phase 3 study of Myelofibrosis, sponsored by Karyopharm Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 353
- Enrollment target
- 20
- Study locations
NCT04562389 is a Phase 3 study of Myelofibrosis that is active but no longer recruiting, run by Karyopharm Therapeutics. The registered enrollment target is 353 participants, above the 190-participant average among 61 other Myelofibrosis trials with a reported enrollment target (86% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT04562389, a Phase 3 study of Myelofibrosis, is active but no longer recruiting, sponsored by Karyopharm Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 353 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 190-participant average among 61 other Myelofibrosis trials with a reported enrollment target (86% higher). The listed sponsor is Karyopharm Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.
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.
NCT04562389 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Maryland, Michigan.
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.
What interventions are being tested in trial NCT04562389?
The interventions under investigation include: Placebo (OTHER), Selinexor (DRUG), Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT04562389?
This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
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