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ACTIVE NOT RECRUITING
NCT04562870
PHASE2

A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis

Sponsor: Karyopharm Therapeutics Inc

View on ClinicalTrials.gov

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

DRUG

Selinexor

Unit Dose Strength: 20 mg; Dose Formulation: Tablet; Dosage Level: 60 or 80 mg, QW; Route of Administration: Oral

OTHER

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