Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Public ClinicalTrials.gov record NCT04562389. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04562389
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 353 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 11, 2021 (Actual)
- Primary completion
- Feb 20, 2026 (Actual)
- Completion
- Mar 2028 (Estimated)
- Last update posted
- Oct 1, 2026
2021 – 2028
United States locations
- U.S. sites
- 36
- U.S. states
- 19
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Division of Hematology/Oncology | Birmingham | Alabama | 35294 | — |
| UCLA - Satellite Site | Beverly Hills | California | 90210 | — |
| City of Hope | Duarte | California | 91010 | — |
| UCLA - Satellite Site | Encino | California | 93003 | — |
| City of Hope - Irvine Lennar - Satellite | Irvine | California | 92618 | — |
| UCLA | Los Angles | California | 90095 | — |
| The Oncology Institute of Hope & Innovation | Pasadena | California | 91105 | — |
| USOR - Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | 80045 | — |
| Smilow Cancer Hospital - New Haven | New Haven | Connecticut | 06511 | — |
| Georgetown Lombardi Comprehensive Center | Washington D.C. | District of Columbia | 20007 | — |
| Norton Cancer Institute - Saint Matthews | Louisville | Kentucky | 40207 | — |
| Maryland Oncology Hematology-Satellite | Annapolis | Maryland | 21401 | — |
| The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21205 | — |
| Maryland Oncology Hematology-Satellite | Brandywine | Maryland | 21004 | — |
| Maryland Oncology Hematology | Columbia | Maryland | 21044 | — |
| Maryland Oncology Hematology-Satellite | Rockville | Maryland | 20850 | — |
| Maryland Oncology Hematology-Satellite | Silver Spring | Maryland | 20904 | — |
| The Cancer & Hematology Centers -Satellite Site | Grand Rapids | Michigan | 49546 | — |
| The Cancer & Hematology Centers of Muskegon | Norton Shores | Michigan | 49444 | — |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Mount Sinai Health System | New York | New York | 10029 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Duke Cancer Institue | Durham | North Carolina | 27705 | — |
| USOR - Oncology Hematology Care - Kenwood | Cincinnati | Ohio | 45242 | — |
| Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43210 | — |
| OhioHealth | Columbus | Ohio | 43214 | — |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Texas Oncology | Dallas | Texas | 75246 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| USOR - Virginia Cancer Specialists - Gainesville Office | Gainesville | Virginia | 20155 | — |
| VCU Massey Cancer Center | Richmond | Virginia | 23298 | — |
| USOR - Virginia Oncology Associates - Virginia Beach | Virginia Beach | Virginia | 23456 | — |
| Fred Hutchinson Cancer Center - SCAA South Lake Union | Seattle | Washington | 98109 | — |
| West Virginia University Cancer Institute, Wheeling Hospital | Wheeling | West Virginia | 26003 | — |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 130 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04562389, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04562389 live on ClinicalTrials.gov.