Phase
Condition
Thrombosis
Myelofibrosis
Dysfunctional Uterine Bleeding
Treatment
Selinexor 60 mg
Selinexor 40 mg
Pacritinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
A diagnosis of MF or post-ET or post-PV MF according to the 2016 World HealthOrganization (WHO) classification of MPN, confirmed by the most recent localpathology report
Measurable splenomegaly during the screening period as demonstrated by spleen volumeof greater than or equal to (>=) 450 cubic square centimeter (cm^3) by MRI or CTscan (results from MRI or CT imaging performed within 28 days prior to C1D1 areacceptable)
DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk
ECOG Performance Status less than or equal to (<=) 2
Platelet count of greater than or equal to (>=) 50 x 10^9/L without platelettransfusion within 7 days prior to the first dose of selinexor
Absolute neutrophil count (ANC) >=1.0 × 10^9/L without need for growth factorswithin 7 days prior to the first dose of selinexor
Adequate liver function as defined by the following: aspartate transaminase (AST)and alanine transaminase (ALT) <= 2.5 × upper limit normal (ULN) and serum totalbilirubin <= 3×ULN
Calculated creatinine clearance (CrCl) greater than (>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula
Active symptoms of MF as determined by presence of at least 2 symptoms with anaverage score >= 5 or total score of >= 12 at screening (at least 5 of 7 consecutivedays immediately preceding C1D1) using the MFSAF V4.0
Must provide bone marrow biopsy samples (samples obtained up to 3 months prior toC1D1 are permitted) at screening and during the study
Currently not eligible for stem cell transplantation
Must be willing to complete the MFSAF V4.0 daily during the study for evaluating thesymptom response (i.e., TSS50)
Exclusion
Key Exclusion Criteria:
More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
Previous treatment with JAK inhibitors for MF
Previous treatment with selinexor or other XPO1 inhibitors
Females who are pregnant or lactating
Prior splenectomy, splenic radiation, or a splenic embolization within 6 monthsprior to C1D1
History of myocardial infarction, unstable angina, percutaneous transluminalcoronary angioplasty (PTCA), coronary artery bypass graft (CABG), cerebrovascularaccident (transient ischemic attack [TIA]), ventricular arrhythmias, congestiveheart failure class > 2 per New York Heart Association (NYHA) within 6 months ofC1D1
Unable to tolerate two forms of antiemetics prior to each dose for the first twocycles
Study Design
Connect with a study center
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Gent
Ghent 2797656, 9000
BelgiumActive - Recruiting
UZ Leuven - Campus Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
UZ Leuven - Campus Gasthuisberg
Leuven 2792482, 3000
BelgiumActive - Recruiting
University Multiprofile Hospital for Active Treatment Sveti George - Base 1
Plovdiv, 4002
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment Sveti George - Base 1
Plovdiv 728193, 4002
BulgariaActive - Recruiting
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
Sofia, 1756
BulgariaActive - Recruiting
University Hospital Sv.Ivan Rilski - Sofia
Sofia, 1431
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment Aleksandrovska
Sofia, 1431
BulgariaActive - Recruiting
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
Sofia 727011, 1756
BulgariaActive - Recruiting
University Hospital Sv.Ivan Rilski - Sofia
Sofia 727011, 1431
BulgariaActive - Recruiting
University Multiprofile Hospital for Active Treatment Aleksandrovska
Sofia 727011, 1431
BulgariaActive - Recruiting
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology
Stara Zagora, 6003
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology
Stara Zagora 726848, 6003
BulgariaActive - Recruiting
Research Institute of the McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Research Institute of the McGill University Health Centre
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaActive - Recruiting
Fakultní nemocnice Olomouc
Olomouc 3069011, 779 00
CzechiaActive - Recruiting
Aarhus Universitetshospital
Aarhus N 11746890, Central Jutland 6418539 8200
DenmarkActive - Recruiting
Institut Bergonié
Bordeaux 3031582, Aquitaine 33000
FranceActive - Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Bénite 2987314, Auvergne-Rhône-Alpes 11071625 69495
FranceActive - Recruiting
CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire
Tours 2972191, Indre-et-Loire 37044
FranceActive - Recruiting
CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire
Tours Cedex 01, Indre-et-Loire 37044
FranceSite Not Available
Chu De Nîmes - Institut De Cancérologie Du Gard
Nîmes, Occitanie 30029
FranceSite Not Available
Chu De Nîmes - Institut De Cancérologie Du Gard
Nîmes 2990363, Occitanie 11071623 30029
FranceActive - Recruiting
Centre Hospitalier Universitaire d'Angers
Angers, Pays de la Loire 49 933
FranceSite Not Available
Centre Hospitalier Universitaire d'Angers
Angers 3037656, Pays de la Loire Region 2988289 49 933
FranceActive - Recruiting
Centre Hospitalier Lyon-Sud
Pierre Bénite, Rhone-Alpes 69495
FranceSite Not Available
Hôpital Cochin
Paris, 75014
FranceActive - Recruiting
Hôpital Saint-Louis
Paris, 75010
FranceSite Not Available
Hôpital Cochin
Paris 2988507, 75014
FranceActive - Recruiting
Hôpital Saint-Louis
Paris 2988507, 75010
FranceActive - Recruiting
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Priest-en-Jarez, 42270
FranceSite Not Available
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Priest-en-Jarez 2977350, 42270
FranceActive - Recruiting
Marien Hospital Düsseldorf
Düsseldorf, 40479
GermanySite Not Available
Marien Hospital Düsseldorf
Düsseldorf 2934246, 40479
GermanyActive - Recruiting
University Hospital Jena
Jena, 7747
GermanySite Not Available
University Hospital Jena
Jena 2895044, 7747
GermanyActive - Recruiting
Laiko General Hospital of Athens
Athens 264371, Attica 6692632 11527
GreeceActive - Recruiting
University General Hospital Attikon
Athens 264371, Attica 6692632 124 62
GreeceActive - Recruiting
"Georgios Papanikolaou" General Hospital of Thessaloniki
Thessaloniki 734077, Central Macedonia 6697801 57010
GreeceActive - Recruiting
University General Hospital of Ioannina, Hematology Department
Ioannina 261779, Epirus 6697804 45500
GreeceActive - Recruiting
University General Hospital of Larissa, Hematology Department
Larissa 258576, Thessaly 6697809 41110
GreeceActive - Recruiting
Semmelweis Egyetem
Budapest, 1088
HungarySite Not Available
Semmelweis Egyetem
Budapest 3054643, 1088
HungaryActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv 293397, Tel Aviv 293396 6423906
IsraelActive - Recruiting
Carmel Medical Center
Haifa 294801, 3436212
IsraelActive - Recruiting
Rambam Health Care Campus
Haifa 294801, 3109601
IsraelActive - Recruiting
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
Milan 3173435, Milan 20122
ItalyActive - Recruiting
Hematology Division, Mauriziano Hospital, University of Turin
Orbassano, Torino 10043
ItalySite Not Available
Hematology Division, Mauriziano Hospital, University of Turin
Orbassano 3171986, Torino 10043
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino 8980539, Turin 10126
ItalyActive - Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
ItalySite Not Available
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna 3181928, 40138
ItalyActive - Recruiting
IRCCS Ospedale Policlinico San Martino
Genova, 16132
ItalySite Not Available
IRCCS Ospedale Policlinico San Martino
Genova 8969657, 16132
ItalyActive - Recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST
Meldola,
ItalySite Not Available
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST
Meldola 3173635,
ItalyActive - Recruiting
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
Milan, 20122
ItalySite Not Available
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan 6951411, 20162
ItalyActive - Recruiting
Istituto Europeo di Oncologia
Milan 6951411, 20141
ItalyActive - Recruiting
Istituto Europeo di Oncologia
Milano, 20141
ItalySite Not Available
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara 3172189, 28100
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo
Pavia 3171366, 27100
ItalyActive - Recruiting
Università Campus Bio-Medico di Roma
Rome, 128
ItalySite Not Available
Università Campus Bio-Medico di Roma
Rome 3169070, 128
ItalyActive - Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seocho-gu, Seoul 6591
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, Seoul Teugbyeolsi 3722
Korea, Republic ofSite Not Available
Pusan National University Hospital
Busan-si, 49241
Korea, Republic ofSite Not Available
Spaarne Gasthuis
Hoofddorp, 2134 TM
NetherlandsSite Not Available
Spaarne Gasthuis
Hoofddorp 2753801, 2134 TM
NetherlandsActive - Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin 765876, 20-954
PolandActive - Recruiting
AIDPORT
Skórzewo, 30 60-185
PolandSite Not Available
AIDPORT
Skórzewo 3085750, 30 60-185
PolandActive - Recruiting
Medicover Clinical Integrated Systems Sp. z o.o.
Torun 3083271, 87-100
PolandActive - Recruiting
Medicover Clinical Integrated Systems Sp. z o.o.
Toruń, 87-100
PolandSite Not Available
Coltea - Spital Clinic
Bucharest, 30167
RomaniaSite Not Available
Coltea - Spital Clinic
Bucharest 683506, 30167
RomaniaActive - Recruiting
Spitalul Filantropia - Craiova
Craiova, 200143
RomaniaSite Not Available
Spitalul Filantropia - Craiova
Craiova 680332, 200143
RomaniaActive - Recruiting
Institutul Regional de Oncologie Iasi
Iași 675810, 700483
RomaniaActive - Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seocho 1836725, Seoul 1835847 6591
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, Seoul Teugbyeolsi 3080
South KoreaActive - Recruiting
Severance Hospital
Seoul 1835848, Seoul Teugbyeolsi 3722
South KoreaActive - Recruiting
Pusan National University Hospital
Busan 1838524, 49241
South KoreaActive - Recruiting
Hospital Universitario Central de Asturias
Oviedo, Asturias 33011
SpainSite Not Available
Hospital Germans Trias i Pujol
Badalona 3129028, Barcelona 8916
SpainActive - Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia 30120
SpainSite Not Available
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar 2518294, Murcia 2513413 30120
SpainActive - Recruiting
Hospital Universitario Central de Asturias
Oviedo 3114711, Principality of Asturias 3114710 33011
SpainActive - Recruiting
Hospital San Pedro de Alcantara
Cáceres, 10003
SpainSite Not Available
Hospital San Pedro de Alcantara
Cáceres 2520611, 10003
SpainActive - Recruiting
Institut Català d'Oncologia Girona
Girona, 17007
SpainSite Not Available
Institut Català d'Oncologia Girona
Girona 3121456, 17007
SpainActive - Recruiting
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas De Gran Canaria, 35010
SpainSite Not Available
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria 2515270, 35010
SpainActive - Recruiting
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, 37007
SpainSite Not Available
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca 3111108, 37007
SpainActive - Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
Hospital Clínico Universitario de Valencia
Valencia 2509954, 46010
SpainActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City 1673820, 807
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei 1668341, 100
TaiwanActive - Recruiting
Taoyuan Chang Gung Memorial Hospital
Taoyuan District 1667905, 333
TaiwanActive - Recruiting
Guy's and Saint Thomas' NHS Foundation Trust
London 2643743, SE1 9RT
United KingdomActive - Recruiting
City of Hope - Duarte Main Site
Duarte, California 91010
United StatesSite Not Available
City of Hope - Duarte Main Site
Duarte 5344147, California 5332921 91010
United StatesActive - Recruiting
Maryland Oncology Hematology - Independent of SCRI/ US Oncology
Columbia, Maryland 21044
United StatesSite Not Available
Maryland Oncology Hematology - Independent of SCRI/ US Oncology
Columbia 4352053, Maryland 4361885 21044
United StatesActive - Recruiting
Weill Cornell Medicine NewYork-Presbyterian
New York, New York 10021
United StatesSite Not Available
Weill Cornell Medicine NewYork-Presbyterian
New York 5128581, New York 5128638 10021
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27705
United StatesSite Not Available
Duke University
Durham 4464368, North Carolina 4482348 27705
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
MD Anderson
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112
United StatesActive - Recruiting

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