Spots Global Cancer Trial Database for KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
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Trial Identification
Brief Title: KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
Official Title: A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT 232 in Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera MF (Post-PV-MF), Or Post Essential Thrombocythemia MF (Post-ET-MF) Who Are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment
Study ID: NCT03662126
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Kirklin Clinic of UAB Hospital, Birmingham, Alabama, United States
University of Southern California Norris Comprehensive Cancer Center, Los Angeles, California, United States
Stanford Cancer Center - Palo Alto, Stanford, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
University Cancer Institute, Boynton Beach, Florida, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Brookdale University Hospital and Medical Center, Brooklyn, New York, United States
New York Presbyterian/Weill Cornell Medical Center, New York, New York, United States
Mt. Sinai, New York, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Medical College of Wisconsin - Froedtert Hospital, Milwaukee, Wisconsin, United States
Sanatorio de la Mujer, Rosario, Santa Fe, Argentina
Instituto Medico Alexander Fleming, Buenos Aires, , Argentina
Centro Medico San Luis, Caba, , Argentina
Hospital Privado - Centro Medico de Cordoba - Oncology, Córdoba, , Argentina
Monash Medical Centre, Clayton, Victoria, Australia
Fiona Stanley Hosital, Murdoch, Western Australia, Australia
Royal Adelaide Hospital, Adelaide, , Australia
The Alfred Hospital, Melbourne, , Australia
South Eastern Private Hospital, Noble Park, , Australia
Icon Cancer Center, South Brisbane, , Australia
Centro de oncologia Leonardo da Vinci, Fortaleza, Ceara, Brazil
Hospital Erasto Gaertner, Curitiba, Parana, Brazil
UNICAMP - Universidade Estadual de Campinas Hemocentro, Campinas, São Paulo, Brazil
Hospital das Clínicas UFG, Goiânia, , Brazil
Fundacao Doutor Amaral Carvalho, Jau, , Brazil
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica, Porto Alegre, , Brazil
Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa, Porto Alegre, , Brazil
Instituto de Ensino e Pesquisa São Lucas, Sao Paulo, , Brazil
Hospital A C Camargo - Fundacao Antonio Prudente, Sao Paulo, , Brazil
Hospital das Clínicas da Universidade de São Paulo, Sao Paulo, , Brazil
Instituto D'or de Pesquisa e Ensino, São Paulo, , Brazil
Instituto COI São Paulo, São Paulo, , 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, , 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, Canada
General Hospital Sibenik, Sibenik, , Croatia
Clinical Hospital Centre Osijek, Zagreb, , Croatia
KB Sestre Milosrdnice, Zagreb, , Croatia
FN Hradec Kralove, Králová, , Czechia
Vseonecma fakultni nemocrince V Praze, Nové Město, , Czechia
Fakultní Nemocnice Olomouc, Olomouc, , Czechia
Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Hématologie Clinique, Amiens, , France
Center Hospitalier Universitaire d'Angers, Angers, , France
C.H de la Côte Basque - Serviv, Bayonne, , France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan, Brest Cedex, , France
Centre Hospitalier Universitaire of Caen Normandie - Côte de Nacre, Caen, , France
Centre Hospitalier Le Mans, Le Mans, , France
Centre Hospitalier Universitaire de Nîmes, Nîmes, , France
Hôpital Saint-Louis, Paris, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers, , France
Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, , France
Hopital Paul Brousse - Aphp Hôpitaux Universitaires Paris Su, Villejuif, , France
Klinikum Rechts der Isar der Technischen Universität München Apotheke, München, Bayern, Germany
Universitätsklinikum Aachen, Aachen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Universitätsklinikum Halle, Halle, Sachsen-Anhalt, Germany
Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle, Dresden, Sachsen, Germany
Technische Universität Dresden, Dresden, Sachsen, Germany
Universitätsklinikum Jena, Jena, Thuringen, Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
UKE - Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz, , Germany
Stauferklinikum Schwäbisch Gmünd, Mutlangen, , Germany
Praxis für Hämatologie und Onkologie, Saarbrücken, , Germany
University General Hospital of Ioannina, Ioánnina, Ioannina, Greece
University Campus of Patras - Hematology, Patras, , Greece
AHEPA General Hospital of Thessaloniki, Thessaloníki, , Greece
Queen Mary Hospital, Hong Kong, , Hong Kong
Prince of Wales Hospital - Medicine, Shatin, , Hong Kong
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, Somogy, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Nyíregyháza, Szabolcs-Szatmar-Bereg, Hungary
Markusovszky Egyetemi Oktatókórház, Szombathely, Vas, Hungary
Semmelweis Egyetem, Budapest, , Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Budapest, , Hungary
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum, Debrecen, , Hungary
Szegedi Tudományegyetem, Szeged, , Hungary
Ha'Emek Medical Center, Afula, , Israel
Assuta Ashdod University Hospital, Ashdod, , Israel
Rambam Medical Centre, Haifa, , Israel
Carmel MC, Haifa, , Israel
Hadassah Medical Organisation, Jerusalem, , Israel
Hematology Institute, Kfar Saba, , Israel
Western Galilee Hospital - Nahariya, Nahariya, , Israel
Rabin Medical Center - Beilinson Hospital, Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center - Oncology, Tel Aviv, , Israel
Assuta MC, Tel Aviv, , Israel
Assaf Harofeh Medical Center - Hematology, Zerifin, , Israel
A.O. San Gerardo di Monza - L'Ospedale San Gerardo di Monza e l'Università di Milano, Monza, Lombardia, Italy
PO Civile SS.Antonio e Biagio, Alessandria, , Italy
AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi, Ancona, , Italy
A.O.di Bologna Policl.S.Orsola, Bologna, , Italy
AO Spedali Civili di Brescia, Brescia, , Italy
Azienda Ospedaliero Universitaria Policlinico - Vittorio Emanuele, Catania, , Italy
AOU Careggi, Firenze, , Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS, Meldola, , Italy
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
AOU Maggiore della Carità, Novara, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord - Pesaro, Pesaro, , Italy
Arcispedale S. Maria Nuova, AO di Reggio Emilia, Reggio Emilia, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
A.O. Citta della Salute e della Scienza di Torino, Torino, , Italy
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Yeungnam University Medical Center, Daegu, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
CHA Bundang Medical Center, CHA University, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Hospital of Lithuanian University of Health Sciences Kaunas, Kaunas, , Lithuania
Universidad Autonoma de Nuevo Leon (UANL) - Hospital Universitario "Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo Leon, Mexico
Instituto Mexicano del Seguro Social, Monterrey, , Mexico
Oaxaca Site Management Organization OSMO, Oaxaca, , Mexico
Sociedad de Metabolismo y Corazón S.C. - Oncology, Veracruz, , Mexico
Perpetual Succour Hospital - Hemat/Transfusion Med, Cebu City, , Philippines
University of the Philippines - Philippine General Hospital, Manila, , Philippines
Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku, Wrocław, Dolnoslaskie, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza, Brzozow, Podkarpackie, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich, Chorzów, Slaskie, Poland
Szpital Uniwersytecki nr 2 im dr. Jana Biziela, Bydgoszcz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, , Poland
SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii, Olsztyn, , Poland
Szpital Wojewódzki w Opolu, Opole, , Poland
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością Medic-R sp. k., Poznań, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Słupsk, , Poland
H. Infante Dom Pedro. Centro Hospitalar do Baixo Vouga, Aveiro, , Portugal
Hospital de Braga, Braga, , Portugal
Instituto Português de Oncologia de Coimbra, Coimbra, , Portugal
H. São Francisco Xavier-Centro Hospitalar Lisboa Ocidental, Lisboa, , Portugal
Champalimaud Cancer Center, Lisbon, , Portugal
Cen Med de Diagn si Trat Amb NEOMED, Brasov, , Romania
Spitalul Clinic Colentina, Bucharest, , Romania
Spitalul Clinic Coltea, Bucuresti, , Romania
Medicover, Bucuresti, , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta", Cluj-Napoca, , Romania
Spitalul Clinic Municipal Filantropia Craiova, Craiova, , Romania
Institutul Regional de Oncologie Iasi, Iaşi, , Romania
Spitalul Clinic Municipal de Urgenta Timisoara, Timişoara, , Romania
Oncomed, Timişoara, , Romania
Spitalul Clinic Judetean de Urgenta Tg Mures, Târgu-Mureş, , Romania
Clinical oncological dispensary, Omsk, , Russian Federation
Saint-Petersburg SMU I.P.Pavlov, St Petersburg, , Russian Federation
Oncologic dispensary of Komi Republic, Syktyvkar, , Russian Federation
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas De Gran Canaria, Las Palmas, Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, Madrid, Spain
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau, Barcelona, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Son Espases, Palma de Mallorca, , Spain
Complejo Hospitalario de Navarra - H. de Navarra, Hematología C/ de Irunlarrea, 3, Pamplona, Pamplona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Doctor Peset, Valencia, , Spain
H. Quirón Zaragoza, Zaragoza, , Spain
National Taiwan University Hospital, Taipei City, Taipei, Taiwan
Chang Gung Medical Foundation - ChiaYi Chang Gung Memorial Hospital - Chiayi Branch, Chiayi City, , Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Ramathibodi Hospital - Mahidol University - Hematology, Bangkok, , Thailand
Siriraj Hospital, Bangkok, , Thailand
Thammasat University Hospital, Khlong Luang, , Thailand
Srinagarind Hospital (KhonKaen University), Khon Kaen, , Thailand
Songklanagarind Hospital, Songkhla, , Thailand
Sakarya Research and Training Hospital, Adapazarı, , Turkey
Ankara University Faculty of Medicine, Ankara, , Turkey
Gazi University Medical Faculty, Ankara, , Turkey
Pamukkale University, Denizli, , Turkey
Gaziantep University Faculty of Medicine, Gaziantep, , Turkey
Inonu University Turgut Ozal Medical Center, Malatya, , Turkey
Mersin University Medical Faculty, Mersin, , Turkey
Ondokuz Mayis University Medical Faculty - Hematology, Samsun, , 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, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
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