• Patient Stories
  • Understanding MPNs
    • Understanding MPNS
    • What Is Polycythemia Vera?
    • What Is Essential Thrombocythemia?
    • What Is Primary Myelofibrosis?
  • Resources
    • Empowered Patients
    • Dictionary
    • Resources
  • Partners
    • Industry Partners
    • International MPN Organizations
    • Partners
  • News Feed
  • Contact
  • MPN Search

PV Reporter

MPN Information and Research Hub

  • About
    • About Us
    • MPN Cancer Connection
    • Contact Us
  • MPN Specialists
  • Blog
  • Media
    • Podcast
      • 01: Polycythemia Vera Diagnosis, PV Reporter, Day 1, Doomsday or Living with a Plan
      • 02: MPN Chronicles – Interview with Dr. Pemmaraju
      • 03: Learn Benefits of Becoming your own MPN Advocate
      • 04: First Hematologist appointment for PV patient
      • 05: Tips to Living Well with an MPN
      • 06: My Plan to beat Coronavirus Blues
    • Videos
    • Dr. Interviews
      • Dr. Jean Jacques Kiladjian ASH 2018 RuxoPeg Phase 1/2 Trial of the Combo of Ruxolitinib and Pegasys in Myelofibrosis Patients
      • Dr. Michael Grunwald ASH 2018 Risk Assessment and Treatment Myelofibrosis Patients at Community Oncology Practices in the U.S.
      • Dr. J.J. Kiladjian ASH 2018 Headline Research Studies
      • ASH 2017 Interview with Dr. Michael Grunwald
        • ASH 2017 Interview with Dr. Raajit Rampal, part 1
        • ASH 2017 with Dr. Raajit Rampal, part 2
        • ASH 2017 Interview with Dr. Jean Jacques Kiladjian, part 1
        • ASH 2017 Interview with Dr. Jean Jacques Kiladjian, part 2
      • ASH 2016 Interviews
        • ASH 2016 Interview with Dr Kiladjian
        • ASH 2016 Interview with Dr Rampal
      • ASH 2015 Interviews
        • ASH 2015 Interview with Dr John Mascarenhas
        • ASH 2015 Interview with Dr Angela Fleischman
      • ASH 2014 Interviews
        • ASH 2014 Interview with Dr Heinz Gisslinger
        • ASH 2014 interview with Dr Richard Stone
  • Treatment
    • How I Treat MPN’s
    • Jakafi
    • INREBIC
    • Interferon treatment for MPNs
  • Support Group

Clinical Trial Finder

Search Results

A Study to Evaluate Safety and Efficacy of Selinexor Versus Treatment of Physician's Choice in Participants With Previously Treated Myelofibrosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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), confirmed 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04562870
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Karyopharm Therapeutics Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China, France, Greece, Hungary, Italy, Poland, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myelofibrosis
Arms & Interventions

Arms

Experimental: Arm S: Selinexor

Participants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive a dose of selinexor 80 mg in first 2 cycles followed by selinexor 60 mg in subsequent cycles orally on Days 1, 8, 15, and 22 of each 28-day cycle to participants on Arm S.

Active Comparator: Arm PC: Physician's Choice Treatment

Participants with MF who had previously received at least 6 months of treatment with JAK 1/2 inhibitor will receive Physician's choice treatment which will be administered as per clinical practice.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

David Geffen School of Medicine at UCLA, Los Angeles, California

Status

Recruiting

Address

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095

Site Contact

Gary Schiller

gschiller@mednet.ucla.edu

310-825-5513

Pasadena, California

Status

Recruiting

Address

The Oncology Institute of Hope and Innovation

Pasadena, California, 91105

Site Contact

Amitabha Mazumder

amazumder@airesearch.us

562-693-4477

Rocky Mountain Cancer Centers, LLP, Aurora, Colorado

Status

Recruiting

Address

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, 80012

Site Contact

Christopher Benton

christopher.benton@usoncology.com

303-418-7639

Southeast Clinical Research Center, Dalton, Georgia

Status

Recruiting

Address

Southeast Clinical Research Center

Dalton, Georgia, 30720

Site Contact

Pablo Perez

pperez@scresearchcenter.com

706-913-1779

Illinois Cancer Specialist, Niles, Illinois

Status

Recruiting

Address

Illinois Cancer Specialist

Niles, Illinois, 60714

Site Contact

Leonard Klein

leonard.klein@usonocology.com

(888) 209-9326

University of New Mexico CCC /NMCCA, Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico CCC /NMCCA

Albuquerque, New Mexico, 87131

Site Contact

Ala Ebaid

aebaid@salud.unm.edu

505-272-4946

Texas Oncology - Northeast Texas, Tyler, Texas

Status

Recruiting

Address

Texas Oncology - Northeast Texas

Tyler, Texas, 75702

Site Contact

Habte Yimer

Habte.Yimer@USONCOLOGY.COM

903-579-9800

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Site Contact

Srinivas Tantravahi

Srinivas.Tantravahi@hci.utah.edu

801-213-6170

Virginia Cancer Specialist, Fairfax, Virginia

Status

Recruiting

Address

Virginia Cancer Specialist

Fairfax, Virginia, 22031

Site Contact

Mitul Gandhi

mitul.gandhi@usoncology.com

703-280-5390

VCU Massey Cancer Center, Richmond, Virginia

Status

Recruiting

Address

VCU Massey Cancer Center

Richmond, Virginia, 23298

Site Contact

Keri Maher

Keri.Maher@vcuhealth.org

760-954-3800

International Sites

Peking University Third Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, Beijing, 100191

Site Contact

Hongmei Jing

clinicaltrials@karyopharm.com

+86 13661112910

Peking Union Medical College Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking Union Medical College Hospital

Beijing, Beijing, 100730

Site Contact

Minghui Duan

mhduan@sina.com

86 13621262462

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080

Site Contact

Jianyu Weng

wengjianyu1969@163.com

86 13924197172

Guangzhou, Guangdong, China

Status

Recruiting

Address

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515

Site Contact

Wang Qiang

sprenaa@163.com

86 18620698390

Henan Cancer Hospital, Zhengzhou, Henan, China

Status

Recruiting

Address

Henan Cancer Hospital

Zhengzhou, Henan, 450003

Site Contact

Hu Zhou

papertigerhu@163.com

86 13939068863

Wuhan, Hubei, China

Status

Recruiting

Address

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022

Site Contact

Min Zhang

Zhangmin35@aliyun.com

86 15 87 18 18 568

Nantong, Jiangsu, China

Status

Recruiting

Address

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001

Site Contact

Hong Liu

clinicaltrials@karyopharm.com

+86 13951300660

Suzhou, Jiangsu, China

Status

Recruiting

Address

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004

Site Contact

Bingzong Li

clinicaltrials@karyopharm.com

+86 13776054037

Suzhou, Jiangsu, China

Status

Recruiting

Address

Suzhou University -The First Affiliated Hospital

Suzhou, Jiangsu, 215007

Site Contact

Suning Chen

chensuning@sina.com

86 138 1488 1746

The First Hospital of Jilin University, Changchun, Jilin, China

Status

Recruiting

Address

The First Hospital of Jilin University

Changchun, Jilin, 130021

Site Contact

Sujun Gao

sujung1963@163.com

86 15843073208

Tianjin Cancer Hospital Airport Hospital, Tianjin, Tianjin, China

Status

Recruiting

Address

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin, 300000

Site Contact

Yafei Wang

yfwang@tmu.edu.cn

+86 13820914401

Hangzhou, Zhejiang, China

Status

Recruiting

Address

Sir Run Run Shaw Hospital - Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016

Site Contact

Jin Zhang

clinicaltrials@karyopharm.com

+86 135 8870 6767

Institut de Cancéro-Hématologie, Brest, Bretagne, France

Status

Recruiting

Address

Institut de Cancéro-Hématologie

Brest, Bretagne, 29609

Site Contact

Jean-Christophe Ianotto

jean-christophe.ianotto@chu-brest.fr

33298223421

Saint Antoine, Paris, France

Status

Recruiting

Address

Sorbonne Universites - Centre De Recherche Saint Antoine (CRSA)

Saint Antoine, Paris, 75012

Site Contact

Rémy Dulery

remy.dulery@aphp.fr

33149282620

Angers, France

Status

Recruiting

Address

Centre Hospitalier Universitaire d'Angers (CHU Angers)

Angers, , 49933

Site Contact

Françoise Boyer

FrBoyer-Perrard@chu-angers.fr

+33 (0) 241355979

Paris, France

Status

Recruiting

Address

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre d'Investigations Cliniques (CIC)

Paris, , 75010

Site Contact

Jean-Jacques Kiladjian

jean-jacques.kiladjian@aphp.fr

33141499494

Pierre Benite, France

Status

Recruiting

Address

Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

Pierre Benite, , 69495

Site Contact

Fiorenza Barraco

fiorenza.barraco@chu-lyon.fr

33478862213

University General Hospital of Patras, Patras, Achaia, Greece

Status

Recruiting

Address

University General Hospital of Patras

Patras, Achaia, 26504

Site Contact

Argiris Symeonidis

argiris.symeonidis@yahoo.gr

+30 2613603247

Athens, Attiki, Greece

Status

Recruiting

Address

General Hospital of Athens "EVAGGELISMOS"

Athens, Attiki, 10676

Site Contact

Sosana Delimpasi

sodeli@yahoo.com

0030 697 720 4193

General Hospital of Ahens "LAIKO", Athens, Attiki, Greece

Status

Recruiting

Address

General Hospital of Ahens "LAIKO"

Athens, Attiki, 11526

Site Contact

Theodoros Vassilakopoulos

clinicaltrial.tvassilakopoulos@gmail.com

+30 6945472338

University General Hospital "ATTIKON", Athens, Attiki, Greece

Status

Recruiting

Address

University General Hospital "ATTIKON"

Athens, Attiki, 12462

Site Contact

Panagiotis Tsirigotis

panagtsirigotis@gmail.com

003 069 44618814

Budapest, Hungary

Status

Recruiting

Address

South Pest Central Hospital, National Inst. Hematol. Inf. Dis.

Budapest, , 1097

Site Contact

Gabor Mikala

gmikala@dpckorhaz.hu

+36 20 913 9907

Pécs University, Pécs, Hungary

Status

Recruiting

Address

Pécs University

Pécs, , 7624

Site Contact

Örs Szabolcs Koszotlányi

kosztolanyi.szabolcs@pte.hu

36209163936

Meldola, Forlì-Cesena, Italy

Status

Recruiting

Address

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

Meldola, Forlì-Cesena, 47014

Site Contact

Alessandro Lucchesi

alessandro.lucchesi@irst.emr.it

+39 0543739281

Orbassano, Turin, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, Turin, 10128

Site Contact

Marco De Gobbi

marco.degobbi@unito.it

39 0119038636

Bologna, Italy

Status

Recruiting

Address

Aou Policlinico S. Orsola - UO Ematologia

Bologna, , 40138

Site Contact

Francesca Palandri

francesca.palandri@unibo.it

+39 0512143044

Firenze, Italy

Status

Recruiting

Address

Università degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - Dipartimento di medicina sperimentale e clinica

Firenze, , 50134

Site Contact

Paola Guglielmelli

paola.guglielmelli@unifi.it

+39 0557947824

Latina, Italy

Status

Recruiting

Address

Azienda Unita Sanitaria Locale Latina - Ospedale Santa Maria Goretti

Latina, , 4100

Site Contact

Giuseppe Cimino

cimino@bce.uniroma1.it

+39 3495378159

Perugia, Italy

Status

Recruiting

Address

University of Perugia Department of Medicine Hematology Section

Perugia, , 6132

Site Contact

Paolo Sportoletti

paolo.sportoletti@unipg.it

39 3474917753

Varese, Italy

Status

Recruiting

Address

Asst Settelaghi, Ospedale Di Circolo E Fondazione Macchi

Varese, , 21100

Site Contact

Francesco Passamonti

francesco.passamonti@asst-settelaghi.it

39 03323939648

Pratia Onkologia Katowice, Katowice, Poland

Status

Recruiting

Address

Pratia Onkologia Katowice

Katowice, , 40-519

Site Contact

Sebastian Grosicki

sgrosicki@wp.pl

+48 600388282

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Site Contact

Rosa Ayala

rayala@ucm.es

34667738252

Powered By
The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

RSS MPN News

  • Contemporary Approach CALR Positive MPNs
  • 9 Tips to Reduce MPN Fatigue
  • Common Clinical Trial Acronyms and Abbreviations
  • Understanding the Phases of Clinical Trials
  • 4th Angel providing one-on-one support services for MPN Patients

MPN 2019 guidelines

MPN 2019 Guidelines, PV Reporter

Click on the image above for the New MPN Patient Guidelines! Very detailed, provided by NCCN.

Medical Dislaimer

Sign up for Our Newsletter!

Copyright · PV Reporter © 2021 · Site Design by David Wallace
error: