Myeloproliferative Neoplasms Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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 (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 (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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

112

Study ID:

NCT04562870

Recruitment Status:

Recruiting

Sponsor:

Karyopharm Therapeutics Inc

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There are 39 Locations for this study

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David Geffen School of Medicine at UCLA
Los Angeles California, 90095, United States More Info
Gary Schiller
Contact
310-825-5513
[email protected]
Gary Schiller
Principal Investigator
The Oncology Institute of Hope and Innovation
Pasadena California, 91105, United States More Info
Amitabha Mazumder
Contact
562-693-4477
[email protected]
Amitabha Mazumder
Principal Investigator
Rocky Mountain Cancer Centers, LLP
Aurora Colorado, 80012, United States More Info
Christopher Benton
Contact
303-418-7639
[email protected]
Christopher Benton
Principal Investigator
Southeast Clinical Research Center
Dalton Georgia, 30720, United States More Info
Pablo Perez
Contact
706-913-1779
[email protected]
Pablo Perez
Principal Investigator
Illinois Cancer Specialist
Niles Illinois, 60714, United States More Info
Leonard Klein
Contact
[email protected]
Leonard Klein
Principal Investigator
University of New Mexico CCC /NMCCA
Albuquerque New Mexico, 87131, United States More Info
Ala Ebaid
Contact
505-272-4946
[email protected]
Ala Ebaid
Principal Investigator
Texas Oncology - Northeast Texas
Tyler Texas, 75702, United States More Info
Habte Yimer
Contact
903-579-9800
[email protected]
Habte Yimer
Principal Investigator
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Srinivas Tantravahi
Contact
801-213-6170
[email protected]
Srinivas Tantravahi
Principal Investigator
Virginia Cancer Specialist
Fairfax Virginia, 22031, United States More Info
Mitul Gandhi
Contact
703-280-5390
[email protected]
Mitul Gandhi
Principal Investigator
VCU Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Keri Maher
Contact
760-954-3800
[email protected]
Keri Maher
Principal Investigator
Peking University Third Hospital
Beijing Beijing, 10019, China More Info
Hongmei Jing
Contact
+86 13661112910
Hongmei Jing
Principal Investigator
Guangdong Provincial People's Hospital
Guangzhou Guangdong, 51008, China More Info
Jianyu Weng
Contact
86 13924197172
[email protected]
Jianyu Weng
Principal Investigator
Nanfang Hospital of Southern Medical University
Guangzhou Guangdong, 51051, China More Info
Wang Qiang
Principal Investigator
Henan Cancer Hospital
Zhengzhou Henan, 45000, China More Info
Hu Zhou
Principal Investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan Hubei, 43002, China More Info
Min Zhang
Principal Investigator
Affiliated Hospital of Nantong University
Nantong Jiangsu, 22600, China More Info
Hong Liu
Contact
+86 13951300660
Hong Liu
Principal Investigator
The Second Affiliated Hospital of Soochow University
Suzhou Jiangsu, 21500, China More Info
Bingzong Li
Contact
+86 13776054037
Bingzong Li
Principal Investigator
Suzhou University -The First Affiliated Hospital
Suzhou Jiangsu, 21500, China More Info
Suning Chen
Principal Investigator
Tianjin Cancer Hospital Airport Hospital
Tianjin Tianjin, 30000, China More Info
Yafei Wang
Principal Investigator
Sir Run Run Shaw Hospital - Zhejiang University School of Medicine
Hangzhou Zhejiang, 31001, China More Info
Jin Zhang
Contact
+86 135 8870 6767
Jin Zhang
Principal Investigator
Institut de Cancéro-Hématologie
Brest Bretagne, 29609, France More Info
Jean-Christophe Ianotto
Contact
33298223421
[email protected]
Jean-Christophe Ianotto
Principal Investigator
Sorbonne Universites - Centre De Recherche Saint Antoine (CRSA)
Saint Antoine Paris, 75012, France More Info
Rémy Dulery
Contact
33149282620
[email protected]
Rémy Dulery
Principal Investigator
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers , 49933, France More Info
Françoise Boyer
Contact
+33 (0) 241355979
[email protected]
Françoise Boyer
Principal Investigator
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre d'Investigations Cliniques (CIC)
Paris , 75010, France More Info
Jean-Jacques Kiladjian
Contact
33141499494
[email protected]
Jean-Jacques Kiladjian
Principal Investigator
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre Benite , 69495, France More Info
Fiorenza Barraco
Contact
33478862213
[email protected]
Fiorenza Barraco
Principal Investigator
University General Hospital of Patras
Patras Achaia, 26504, Greece More Info
Argiris Symeonidis
Contact
+30 2613603247
[email protected]
Argiris Symeonidis
Principal Investigator
General Hospital of Athens "EVAGGELISMOS"
Athens Attiki, 10676, Greece More Info
Sosana Delimpasi
Contact
0030 697 720 4193
[email protected]
Sosana Delimpasi
Principal Investigator
General Hospital of Ahens "LAIKO"
Athens Attiki, 11526, Greece More Info
Theodoros Vassilakopoulos
Contact
+30 6945472338
[email protected]
Theodoros Vassilakopoulos
Principal Investigator
University General Hospital "ATTIKON"
Athens Attiki, 12462, Greece More Info
Panagiotis Tsirigotis
Contact
003 069 44618814
[email protected]
Panagiotis Tsirigotis
Principal Investigator
South Pest Central Hospital, National Inst. Hematol. Inf. Dis.
Budapest , 1097, Hungary More Info
Gabor Mikala
Contact
+36 20 913 9907
[email protected]
Gabor Mikala
Principal Investigator
Pécs University
Pécs , 7624, Hungary More Info
Örs Szabolcs Koszotlányi
Contact
36209163936
[email protected]
Örs Szabolcs Koszotlányi
Principal Investigator
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola Forlì-Cesena, 47014, Italy More Info
Alessandro Lucchesi
Contact
+39 0543739281
[email protected]
Alessandro Lucchesi
Principal Investigator
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano Turin, 10128, Italy More Info
Marco De Gobbi
Contact
39 0119038636
[email protected]
Marco De Gobbi
Principal Investigator
Aou Policlinico S. Orsola - UO Ematologia
Bologna , 40138, Italy More Info
Francesca Palandri
Contact
+39 0512143044
[email protected]
Francesca Palandri
Principal Investigator
Università degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - Dipartimento di medicina sperimentale e clinica
Firenze , 50134, Italy More Info
Paola Guglielmelli
Contact
+39 0557947824
[email protected]
Paola Guglielmelli
Principal Investigator
Azienda Unita Sanitaria Locale Latina - Ospedale Santa Maria Goretti
Latina , 4100, Italy More Info
Giuseppe Cimino
Contact
+39 3495378159
[email protected]
Giuseppe Cimino
Principal Investigator
University of Perugia Department of Medicine Hematology Section
Perugia , 6132, Italy More Info
Paolo Sportoletti
Contact
39 3474917753
[email protected]
Paolo Sportoletti
Principal Investigator
Asst Settelaghi, Ospedale Di Circolo E Fondazione Macchi
Varese , 21100, Italy More Info
Francesco Passamonti
Contact
39 03323939648
[email protected]
Francesco Passamonti
Principal Investigator
Pratia Onkologia Katowice
Katowice , 40-51, Poland More Info
Sebastian Grosicki
Contact
+48 600388282
[email protected]
Sebastian Grosicki
Principal Investigator
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain More Info
Rosa Ayala
Contact
34667738252
[email protected]
Rosa Ayala
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

112

Study ID:

NCT04562870

Recruitment Status:

Recruiting

Sponsor:


Karyopharm Therapeutics Inc

How clear is this clinincal trial information?

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