Myeloproliferative Neoplasms Clinical Trial

KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment

Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.

This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
Failure of prior treatment with JAK inhibitor
ECOG ≤ 2

Exclusion Criteria:

Prior splenectomy
Splenic irradiation within 3 months prior to randomization
History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
Prior MDM2 inhibitor therapy or p53-directed therapy
Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
History of major organ transplant
Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

385

Study ID:

NCT03662126

Recruitment Status:

Recruiting

Sponsor:

Kartos Therapeutics, Inc.

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There are 163 Locations for this study

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The Kirklin Clinic of UAB Hospital
Birmingham Alabama, 35294, United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Stanford Cancer Center - Palo Alto
Stanford California, 94305, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
University Cancer Institute
Boynton Beach Florida, 33426, United States
Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
University of Illinois at Chicago
Chicago Illinois, 60612, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Brookdale University Hospital and Medical Center
Brooklyn New York, 11212, United States
New York Presbyterian/Weill Cornell Medical Center
New York New York, 10021, United States
Mt. Sinai
New York New York, 10029, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Medical College of Wisconsin - Froedtert Hospital
Milwaukee Wisconsin, 53226, United States
Sanatorio de la Mujer
Rosario Santa Fe, S2000, Argentina
Instituto Medico Alexander Fleming
Buenos Aires , , Argentina
Centro Medico San Luis
Caba , 1425, Argentina
Hospital Privado - Centro Medico de Cordoba - Oncology
Córdoba , X5016, Argentina
Monash Medical Centre
Clayton Victoria, 3168, Australia
Fiona Stanley Hosital
Murdoch Western Australia, 6150, Australia
Royal Adelaide Hospital
Adelaide , , Australia
The Alfred Hospital
Melbourne , , Australia
South Eastern Private Hospital
Noble Park , 3174, Australia
Icon Cancer Center
South Brisbane , , Australia
Centro de oncologia Leonardo da Vinci
Fortaleza Ceara, 60140, Brazil
Hospital Erasto Gaertner
Curitiba Parana, 81520, Brazil
UNICAMP - Universidade Estadual de Campinas Hemocentro
Campinas São Paulo, 13083, Brazil
Hospital das Clínicas UFG
Goiânia , 74605, Brazil
Fundacao Doutor Amaral Carvalho
Jau , 17210, Brazil
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
Porto Alegre , 90035, Brazil
Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa
Porto Alegre , 90880, Brazil
Instituto de Ensino e Pesquisa São Lucas
Sao Paulo , 01236, Brazil
Hospital A C Camargo - Fundacao Antonio Prudente
Sao Paulo , 01509, Brazil
Hospital das Clínicas da Universidade de São Paulo
Sao Paulo , 05403, Brazil
Instituto D'or de Pesquisa e Ensino
São Paulo , 04502, Brazil
Instituto COI São Paulo
São Paulo , 13210, Brazil
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven
Pleven , , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv
Plovdiv , , Bulgaria
Military Medical Academy, Multiprofile for active treatment, Sofia
Sofia , 1606, Bulgaria
Acibadem City Clinic Tokuda Hospital, Sofia
Sofia , , Bulgaria
Specialized Hospital for Active Therapy of Hematological Disorders
Sofia , , Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska, Sofia
Sofia , , Bulgaria
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski, Sofia
Sofia , , Bulgaria
Princess Margaret Cancer Center
Toronto Ontario, M5G 2, Canada
General Hospital Sibenik
Sibenik , 22000, Croatia
Clinical Hospital Centre Osijek
Zagreb , 10000, Croatia
KB Sestre Milosrdnice
Zagreb , 10000, Croatia
FN Hradec Kralove
Králová , 500 0, Czechia
Vseonecma fakultni nemocrince V Praze
Nové Město , , Czechia
Fakultní Nemocnice Olomouc
Olomouc , 779 0, Czechia
Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Hématologie Clinique
Amiens , 80054, France
Center Hospitalier Universitaire d'Angers
Angers , 49933, France
C.H de la Côte Basque - Serviv
Bayonne , 64100, France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest Cedex , 29609, France
Centre Hospitalier Universitaire of Caen Normandie - Côte de Nacre
Caen , 14000, France
Centre Hospitalier Le Mans
Le Mans , , France
Centre Hospitalier Universitaire de Nîmes
Nîmes , 30029, France
Hôpital Saint-Louis
Paris , 75010, France
Centre Hospitalier Universitaire de Poitiers
Poitiers , , France
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse , 31059, France
Hopital Paul Brousse - Aphp Hôpitaux Universitaires Paris Su
Villejuif , 94800, France
Klinikum Rechts der Isar der Technischen Universität München Apotheke
München Bayern, 81675, Germany
Universitätsklinikum Aachen
Aachen Nordrhein-Westfalen, 52074, Germany
Universitaetsklinikum Essen
Essen Nordrhein-Westfalen, 45147, Germany
Universitätsklinikum Halle
Halle Sachsen-Anhalt, 06120, Germany
Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle
Dresden Sachsen, 01307, Germany
Technische Universität Dresden
Dresden Sachsen, 01307, Germany
Universitätsklinikum Jena
Jena Thuringen, 07747, Germany
Charité Universitätsmedizin Berlin
Berlin , 13353, Germany
UKE - Universitätsklinikum Hamburg-Eppendorf
Hamburg , 20251, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz , , Germany
Stauferklinikum Schwäbisch Gmünd
Mutlangen , 73557, Germany
Praxis für Hämatologie und Onkologie
Saarbrücken , 66113, Germany
University General Hospital of Ioannina
Ioánnina Ioannina, 45500, Greece
University Campus of Patras - Hematology
Patras , 26504, Greece
AHEPA General Hospital of Thessaloniki
Thessaloníki , 54636, Greece
Queen Mary Hospital
Hong Kong , 15000, Hong Kong
Prince of Wales Hospital - Medicine
Shatin , , Hong Kong
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár Somogy, 7400, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
Nyíregyháza Szabolcs-Szatmar-Bereg, 4400, Hungary
Markusovszky Egyetemi Oktatókórház
Szombathely Vas, H-970, Hungary
Semmelweis Egyetem
Budapest , 1083, Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
Budapest , , Hungary
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
Debrecen , 4032, Hungary
Szegedi Tudományegyetem
Szeged , 6725, Hungary
Ha'Emek Medical Center
Afula , 18341, Israel
Assuta Ashdod University Hospital
Ashdod , , Israel
Rambam Medical Centre
Haifa , 31096, Israel
Carmel MC
Haifa , , Israel
Hadassah Medical Organisation
Jerusalem , 91120, Israel
Hematology Institute
Kfar Saba , 44281, Israel
Western Galilee Hospital - Nahariya
Nahariya , 22100, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva , 49100, Israel
Tel Aviv Sourasky Medical Center - Oncology
Tel Aviv , 64239, Israel
Assuta MC
Tel Aviv , 64239, Israel
Assaf Harofeh Medical Center - Hematology
Zerifin , 70300, Israel
A.O. San Gerardo di Monza - L'Ospedale San Gerardo di Monza e l'Università di Milano
Monza Lombardia, 20900, Italy
PO Civile SS.Antonio e Biagio
Alessandria , 15121, Italy
AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
Ancona , 60123, Italy
A.O.di Bologna Policl.S.Orsola
Bologna , 41038, Italy
AO Spedali Civili di Brescia
Brescia , 25123, Italy
Azienda Ospedaliero Universitaria Policlinico - Vittorio Emanuele
Catania , 95123, Italy
AOU Careggi
Firenze , 50141, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
Meldola , , Italy
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
Milano , 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
AOU Maggiore della Carità
Novara , 28100, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord - Pesaro
Pesaro , 61121, Italy
Arcispedale S. Maria Nuova, AO di Reggio Emilia
Reggio Emilia , 42123, Italy
Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
A.O. Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Inje University Busan Paik Hospital
Busan , 47392, Korea, Republic of
Kyungpook National University Hospital
Daegu , 41944, Korea, Republic of
Yeungnam University Medical Center
Daegu , 42415, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu , 42601, Korea, Republic of
CHA Bundang Medical Center, CHA University
Seongnam-si , Seong, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 6591, Korea, Republic of
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas , LT-50, Lithuania
Universidad Autonoma de Nuevo Leon (UANL) - Hospital Universitario "Dr. Jose Eleuterio Gonzalez
Monterrey Nuevo Leon, 64460, Mexico
Instituto Mexicano del Seguro Social
Monterrey , 64180, Mexico
Oaxaca Site Management Organization OSMO
Oaxaca , 6800, Mexico
Sociedad de Metabolismo y Corazón S.C. - Oncology
Veracruz , 91910, Mexico
Perpetual Succour Hospital - Hemat/Transfusion Med
Cebu City , 6000, Philippines
University of the Philippines - Philippine General Hospital
Manila , 1000, Philippines
Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
Wrocław Dolnoslaskie, 53-43, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
Brzozow Podkarpackie, 36-20, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
Chorzów Slaskie, 41-50, Poland
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz , 86-16, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin , 20-08, Poland
SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii
Olsztyn , , Poland
Szpital Wojewódzki w Opolu
Opole , 45-06, Poland
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością Medic-R sp. k.
Poznań , 60-84, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
SÅ‚upsk , 76-20, Poland
H. Infante Dom Pedro. Centro Hospitalar do Baixo Vouga
Aveiro , 3814-, Portugal
Hospital de Braga
Braga , 4710-, Portugal
Instituto Português de Oncologia de Coimbra
Coimbra , 3000-, Portugal
H. São Francisco Xavier-Centro Hospitalar Lisboa Ocidental
Lisboa , 1495-, Portugal
Champalimaud Cancer Center
Lisbon , 1400-, Portugal
Cen Med de Diagn si Trat Amb NEOMED
Brasov , 50028, Romania
Spitalul Clinic Colentina
Bucharest , 02012, Romania
Spitalul Clinic Coltea
Bucuresti , 03017, Romania
Medicover
Bucuresti , 06020, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
Cluj-Napoca , 40001, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova , 20014, Romania
Institutul Regional de Oncologie Iasi
IaÅŸi , 70048, Romania
Spitalul Clinic Municipal de Urgenta Timisoara
TimiÅŸoara , 30007, Romania
Oncomed
TimiÅŸoara , 30032, Romania
Spitalul Clinic Judetean de Urgenta Tg Mures
Târgu-Mureş , 54013, Romania
Clinical oncological dispensary
Omsk , 64401, Russian Federation
Saint-Petersburg SMU I.P.Pavlov
St Petersburg , 19708, Russian Federation
Oncologic dispensary of Komi Republic
Syktyvkar , 16790, Russian Federation
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas De Gran Canaria Las Palmas, 35010, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda Madrid, 28222, Spain
Hospital Universitario Vall d'Hebrón
Barcelona , 08035, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona , 8041, Spain
Hospital San Pedro de Alcantara
Cáceres , 1003, Spain
Hospital Universitario Virgen de la Victoria
Málaga , 29010, Spain
Hospital Universitario Son Espases
Palma de Mallorca , 07120, Spain
Complejo Hospitalario de Navarra - H. de Navarra, Hematología C/ de Irunlarrea, 3, Pamplona
Pamplona , 31008, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Doctor Peset
Valencia , 46017, Spain
H. Quirón Zaragoza
Zaragoza , 50012, Spain
National Taiwan University Hospital
Taipei City Taipei, 100, Taiwan
Chang Gung Medical Foundation - ChiaYi Chang Gung Memorial Hospital - Chiayi Branch
Chiayi City , , Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Ramathibodi Hospital - Mahidol University - Hematology
Bangkok , 10400, Thailand
Siriraj Hospital
Bangkok , 10700, Thailand
Thammasat University Hospital
Khlong Luang , 12120, Thailand
Srinagarind Hospital (KhonKaen University)
Khon Kaen , 40002, Thailand
Songklanagarind Hospital
Songkhla , 90110, Thailand
Sakarya Research and Training Hospital
Adapazarı , 54100, Turkey
Ankara University Faculty of Medicine
Ankara , 06500, Turkey
Gazi University Medical Faculty
Ankara , 06500, Turkey
Pamukkale University
Denizli , 20160, Turkey
Gaziantep University Faculty of Medicine
Gaziantep , 27100, Turkey
Inonu University Turgut Ozal Medical Center
Malatya , 44280, Turkey
Mersin University Medical Faculty
Mersin , 33110, Turkey
Ondokuz Mayis University Medical Faculty - Hematology
Samsun , 55280, Turkey
University Hospitals Birmingham NHS Foundation Trust
Birmingham , , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow , , United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust
London , SE1 9, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

385

Study ID:

NCT03662126

Recruitment Status:

Recruiting

Sponsor:


Kartos Therapeutics, Inc.

How clear is this clinincal trial information?

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