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Clinical Trials in China / NCT04562870
Active, not recruiting Phase 2

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

NCT04562870 · tracked via the Priya Life Science China tracker
Sponsor
Karyopharm Therapeutics Inc
Phase
Phase 2
Started
2021-03-17
Last updated
2026-07-02

Condition(s) studied

Myelofibrosis

Investigational drug(s) / intervention(s)

SelinexorPhysician's Choice Treatment

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * A diagnosis of primary MF or post-essential thrombocythemia (ET) or post-polycythemia (PV) MF according to the 2016 World Health Organization (WHO) classification of myeloproliferative neoplasms (MPN), by the most recent local pathology report. * Previous treatment with JAK inhibitors for at least 6 months. * Measurable splenomegaly during the screening period as demonstrated by spleen volume of ≥450 centimeter cube (cm\^3) by magnetic resonance imaging (MRI) or computerized tomography (CT) scan. * Relapsed, Refractory or Intolerant to JAK inhibitors as defined as meeting one of the criteria below: * less than (\<) 35% spleen volume reduction by MRI or CT-scan (from baseline) or * \<50% decrease in spleen size by palpation (from baseline) or an increase of at least 3 cm with the spleen at least 5 cm below the left costal margin or * Spleen volume increase greater than (\>) 25% from nadir or a return to within 10% of baseline after any initial response or * Treatment with JAK inhibitor was complicated by development of red blood cells (RBC) transfusion requirement (2 units per month for 2 month); or grade 3 thrombocytopenia, anemia, hematoma/hemorrhage; or grade 2 non-hematologic toxicity while on JAK inhibitors * Participants ≥18 years of age. * Eastern Cooperative Oncology Group (ECOG) less than or equal to (≤) 2. * Platelet count ≥75\*10\^9 per liter (/L). * Absolute neutrophil count (ANC) ≥1.5\*10\^9/L. * Serum direct bilirubin ≤1.5\*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5\*ULN. * Calculated creatinine clearance (CrCl) \>15 milliliter (mL)/minute (min) based on the Cockcroft and Gault formula. * Participants with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for \>8 weeks and viral load is \<100 International Units (IU)/mL. * Participants with untreated hepatitis C virus (HCV) are eligible if there is a documentation of negative viral load per institutional standard. * Participants with history of human immunodeficiency virus (HIV) are eligible if they have cluster of differentiation 4 (CD4)+ T-cell counts ≥350 cells/microliter (mcL), negative viral load per institutional standard, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year. * Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception throughout the study and for at least 90 days after the last dose of selinexor, or for the duration as stated on the label (SmPC/USPI) for those on the comparator drug (physician's choice arm). Childbearing potential excludes: Age \>50 years and naturally amenorrhoeic for \>1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy. * Male participants who are sexually active must use highly effective methods of contraception throughout the study and for at least 90 days after the last dose of selinexor, or for the duration as stated on the label (SmPC/USPI) for those on the comparator drug (physician's choice arm). Male participants must agree not to donate sperm during the study treatment period. * Participants must sign written informed consent in accordance with federal, local and institutional guidelines. Exclusion Criteria: * \>5% blasts in peripheral blood or \>10% blasts in bone marrow (i.e., accelerated phase). * Previous treatment with selinexor or other exportin 1 (XPO1) inhibitors. * Use of any standard or experimental anti-MF therapy \<21 days prior to Cycle 1 Day 1 (hydroxyurea or growth factors are allowed). * Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of selinexor (Example: vomiting, or diarrhea that is Common Terminology Criteria for Adverse Events (CTCAE) grade \>1). * Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to selinexor dosing or strong CYP3A inducers ≤14 days prior to selinexor dosing. * Major surgery \<28 days prior to cycle 1 day 1 (C1D1). * Uncontrolled (ie, clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral). * Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participants safety, prevent the participant from giving informed consent, or being compliant with the study procedures. * Female participants who are pregnant or lactating. * Participants with contraindications to use of selinexor or all the drugs intended to be used in the comparative treatment arm.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
The Oncology Institute of Hope and Innovation Pasadena California
Rocky Mountain Cancer Centers, LLP Aurora Colorado
Illinois Cancer Specialist Niles Illinois
Texas Oncology - Northeast Texas Tyler Texas
Peking Union Medical College Hospital Beijing Beijing Municipality
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Affiliated Hospital of Nantong University Nantong Jiangsu
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
Suzhou University -The First Affiliated Hospital Suzhou Jiangsu
The First Hospital of Jilin University Changchun Jilin
Sir Run Run Shaw Hospital - Zhejiang University School of Medicine Hangzhou Zhejiang
Institut de Cancéro-Hématologie Brest Brittany Region
Centre Hospitalier Universitaire d'Angers (CHU Angers) Angers France
University General Hospital "ATTIKON" Athens Attica
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS Meldola Forlì-Cesena
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

More Karyopharm Therapeutics Inc trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04562870 on ClinicalTrials.gov ↗ ← All trials in China