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A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis
Sponsor: Karyopharm Therapeutics Inc
Summary
This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician's choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Study participants will be randomized in a 1:1 ratio to either receive selinexor or physicians' choice of treatment.
Official title: A Phase 2, Randomized, Open-Label, Multicenter Study to Evaluate Safety and Efficacy of Single Agent Selinexor Versus Treatment of Physician's Choice in Patients With Previously Treated Myelofibrosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2021-03-17
Completion Date
2026-09
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
Selinexor
Unit Dose Strength: 20 mg; Dose Formulation: Tablet; Dosage Level: 60 or 80 mg, QW; Route of Administration: Oral
Physician's Choice Treatment
Physician's choice treatment may include ruxolitinib retreatment, fedratinib, chemotherapy (e.g., hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulatory agent, androgen, interferon (all as per clinical practice) and may include supportive care only with no MF treatment; no investigational therapies are allowed.
Locations (21)
The Oncology Institute of Hope and Innovation
Pasadena, California, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
Illinois Cancer Specialist
Niles, Illinois, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Suzhou University -The First Affiliated Hospital
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Sir Run Run Shaw Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Institut de Cancéro-Hématologie
Brest, Brittany Region, France
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers, France
University General Hospital "ATTIKON"
Athens, Attica, Greece
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola, Forlì-Cesena, Italy
Università degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - Dipartimento di medicina sperimentale e clinica
Florence, Italy
Azienda Unita Sanitaria Locale Latina - Ospedale Santa Maria Goretti
Latina, Italy
University of Perugia Department of Medicine Hematology Section
Perugia, Italy
Asst Settelaghi, Ospedale Di Circolo E Fondazione Macchi
Varese, Italy
Pratia Onkologia Katowice
Katowice, Poland
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain