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
Who is this study for? Adult patients with Myelofibrosis
What treatments are being studied? KRT-232 MDM2 Small Molecule Inhibitor
Status: Recruiting
Location: See all (188) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
The Kirklin Clinic of UAB Hospital
ACTIVE_NOT_RECRUITING
Birmingham
California
University of Southern California Norris Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Los Angeles
Stanford Cancer Center - Palo Alto
ACTIVE_NOT_RECRUITING
Stanford
Innovative Clinical Research Institute
COMPLETED
Whittier
Florida
University Cancer Institute
WITHDRAWN
Boynton Beach
Illinois
Northwestern University Feinberg School of Medicine
COMPLETED
Chicago
University of Illinois at Chicago
RECRUITING
Chicago
Massachusetts
Dana-Farber Cancer Institute
WITHDRAWN
Boston
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New York
Brookdale University Hospital and Medical Center
RECRUITING
Brooklyn
Mt. Sinai
RECRUITING
New York
New York Presbyterian/Weill Cornell Medical Center
WITHDRAWN
New York
Ohio
Gabrail Cancer Center
RECRUITING
Canton
The Ohio State University Comprehensive Cancer Center
COMPLETED
Columbus
Oregon
Oregon Health and Science University
COMPLETED
Portland
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Wisconsin
Medical College of Wisconsin - Froedtert Hospital
RECRUITING
Milwaukee
Other Locations
Argentina
Instituto Medico Alexander Fleming
RECRUITING
Buenos Aires
Centro Medico San Luis
RECRUITING
Caba
Hospital Privado - Centro Medico de Cordoba - Oncology
RECRUITING
Córdoba
Sanatorio de la Mujer
RECRUITING
Rosario
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Monash Medical Centre
RECRUITING
Clayton
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hosital
RECRUITING
Murdoch
South Eastern Private Hospital
RECRUITING
Noble Park
Icon Cancer Center
RECRUITING
South Brisbane
Brazil
UNICAMP - Universidade Estadual de Campinas Hemocentro
RECRUITING
Campinas
Hospital Erasto Gaertner
RECRUITING
Curitiba
Centro de oncologia Leonardo da Vinci
RECRUITING
Fortaleza
Hospital das Clínicas UFG
RECRUITING
Goiânia
Fundacao Doutor Amaral Carvalho
RECRUITING
Jaú
Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa
RECRUITING
Porto Alegre
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
RECRUITING
Porto Alegre
Hospital A C Camargo - Fundacao Antonio Prudente
RECRUITING
São Paulo
Hospital das Clínicas da Universidade de São Paulo
RECRUITING
São Paulo
Instituto COI São Paulo
RECRUITING
São Paulo
Instituto D'or de Pesquisa e Ensino
RECRUITING
São Paulo
Instituto de Ensino e Pesquisa São Lucas
RECRUITING
São Paulo
Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven
RECRUITING
Pleven
University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv
RECRUITING
Plovdiv
Acibadem City Clinic Tokuda Hospital, Sofia
RECRUITING
Sofia
Military Medical Academy, Multiprofile for active treatment, Sofia
RECRUITING
Sofia
Specialized Hospital for Active Therapy of Hematological Disorders
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Alexandrovska, Sofia
WITHDRAWN
Sofia
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski, Sofia
RECRUITING
Sofia
Canada
Princess Margaret Cancer Center
ACTIVE_NOT_RECRUITING
Toronto
Croatia
General Hospital Sibenik
RECRUITING
Šibenik
Clinical Hospital Centre Osijek
RECRUITING
Zagreb
KB Sestre Milosrdnice
RECRUITING
Zagreb
France
Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Hématologie Clinique
RECRUITING
Amiens
Center Hospitalier Universitaire d'Angers
RECRUITING
Angers
C.H de la Côte Basque - Serviv
RECRUITING
Bayonne
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
RECRUITING
Brest
Centre Hospitalier Universitaire of Caen Normandie - Côte de Nacre
ACTIVE_NOT_RECRUITING
Caen
Centre Hospitalier Le Mans
RECRUITING
Le Mans
Centre Hospitalier Universitaire de Nîmes
ACTIVE_NOT_RECRUITING
Nîmes
Hôpital Saint-Louis
RECRUITING
Paris
Centre Hospitalier Universitaire de Poitiers
RECRUITING
Poitiers
Institut Universitaire du Cancer de Toulouse Oncopole
RECRUITING
Toulouse
Hopital Paul Brousse - Aphp Hôpitaux Universitaires Paris Su
RECRUITING
Villejuif
Germany
Universitätsklinikum Aachen
ACTIVE_NOT_RECRUITING
Aachen
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle
RECRUITING
Dresden
Technische Universität Dresden
RECRUITING
Dresden
Universitaetsklinikum Essen
RECRUITING
Essen
Universitätsklinikum Halle
RECRUITING
Halle
UKE - Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Universitätsklinikum Jena
RECRUITING
Jena
Universitätsmedizin der Johannes Gutenberg Universität Mainz
ACTIVE_NOT_RECRUITING
Mainz
Klinikum Rechts der Isar der Technischen Universität München Apotheke
RECRUITING
München
Stauferklinikum Schwäbisch Gmünd
RECRUITING
Mutlangen
Praxis für Hämatologie und Onkologie
RECRUITING
Saarbrücken
Greece
University General Hospital of Ioannina
RECRUITING
Ioannina
University Campus of Patras - Hematology
RECRUITING
Pátrai
AHEPA General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Prince of Wales Hospital - Medicine
RECRUITING
Shatin
Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
RECRUITING
Budapest
Semmelweis Egyetem
WITHDRAWN
Budapest
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
COMPLETED
Debrecen
Somogy Megyei Kaposi Mór Oktató Kórház
WITHDRAWN
Kaposvár
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
RECRUITING
Nyíregyháza
Szegedi Tudományegyetem
RECRUITING
Szeged
Markusovszky Egyetemi Oktatókórház
RECRUITING
Szombathely
Israel
Ha'Emek Medical Center
RECRUITING
Afula
Assuta Ashdod University Hospital
RECRUITING
Ashdod
Carmel MC
RECRUITING
Haifa
Rambam Medical Centre
RECRUITING
Haifa
Hadassah Medical Organisation
RECRUITING
Jerusalem
Hematology Institute
RECRUITING
Kfar Saba
Western Galilee Hospital - Nahariya
RECRUITING
Nahariya
Rabin Medical Center - Beilinson Hospital
RECRUITING
Petah Tikva
Assuta MC
RECRUITING
Tel Aviv
Tel Aviv Sourasky Medical Center - Oncology
RECRUITING
Tel Aviv
Assaf Harofeh Medical Center - Hematology
RECRUITING
Ẕerifin
Italy
PO Civile SS.Antonio e Biagio
RECRUITING
Alessandria
AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
RECRUITING
Ancona
A.O.di Bologna Policl.S.Orsola
RECRUITING
Bologna
AO Spedali Civili di Brescia
RECRUITING
Brescia
Azienda Ospedaliero Universitaria Policlinico - Vittorio Emanuele
RECRUITING
Catania
AOU Careggi
RECRUITING
Florence
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST IRCCS
RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
RECRUITING
Milan
A.O. San Gerardo di Monza - L'Ospedale San Gerardo di Monza e l'Università di Milano
RECRUITING
Monza
AOU Maggiore della Carità
RECRUITING
Novara
Azienda Ospedaliera Ospedali Riuniti Marche Nord - Pesaro
RECRUITING
Pesaro
Arcispedale S. Maria Nuova, AO di Reggio Emilia
RECRUITING
Reggio Emilia
Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
A.O. Citta della Salute e della Scienza di Torino
RECRUITING
Torino
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas
RECRUITING
Kaunas
Mexico
Instituto Mexicano del Seguro Social
RECRUITING
Monterrey
Universidad Autonoma de Nuevo Leon (UANL) - Hospital Universitario Dr. Jose Eleuterio Gonzalez
RECRUITING
Monterrey
Oaxaca Site Management Organization OSMO
RECRUITING
Oaxaca City
Sociedad de Metabolismo y Corazón S.C. - Oncology
RECRUITING
Veracruz
Philippines
Perpetual Succour Hospital - Hemat/Transfusion Med
RECRUITING
Cebu City
University of the Philippines - Philippine General Hospital
RECRUITING
Manila
Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
ACTIVE_NOT_RECRUITING
Brzozów
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
RECRUITING
Bydgoszcz
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
RECRUITING
Chorzów
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
WITHDRAWN
Lublin
SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii
RECRUITING
Olsztyn
Szpital Wojewódzki w Opolu
RECRUITING
Opole
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością Medic-R sp. k.
WITHDRAWN
Poznan
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
RECRUITING
Słupsk
Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
RECRUITING
Wroclaw
Portugal
H. Infante Dom Pedro. Centro Hospitalar do Baixo Vouga
RECRUITING
Aveiro
Hospital de Braga
RECRUITING
Braga
Instituto Português de Oncologia de Coimbra
RECRUITING
Coimbra
Champalimaud Cancer Center
RECRUITING
Lisbon
H. São Francisco Xavier-Centro Hospitalar Lisboa Ocidental
RECRUITING
Lisbon
Republic of Korea
Inje University Busan Paik Hospital
RECRUITING
Busan
Keimyung University Dongsan Medical Center
RECRUITING
Daegu
Kyungpook National University Hospital
RECRUITING
Daegu
Yeungnam University Medical Center
RECRUITING
Daegu
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
Romania
Cen Med de Diagn si Trat Amb NEOMED
RECRUITING
Brasov
Medicover
RECRUITING
Bucharest
Spitalul Clinic Colentina
RECRUITING
Bucharest
Spitalul Clinic Coltea
RECRUITING
Bucharest
Institutul Oncologic Prof. Dr. Ion Chiricuta
RECRUITING
Cluj-napoca
Spitalul Clinic Municipal Filantropia Craiova
RECRUITING
Craiova
Institutul Regional de Oncologie Iasi
RECRUITING
Iași
Spitalul Clinic Judetean de Urgenta Tg Mures
RECRUITING
Târgu Mureş
Oncomed
RECRUITING
Timișoara
Spitalul Clinic Municipal de Urgenta Timisoara
RECRUITING
Timișoara
Russian Federation
Clinical oncological dispensary
WITHDRAWN
Omsk
Saint-Petersburg SMU I.P.Pavlov
WITHDRAWN
Saint Petersburg
Oncologic dispensary of Komi Republic
WITHDRAWN
Syktyvkar
Spain
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital de La Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebrón
RECRUITING
Barcelona
Hospital San Pedro de Alcantara
RECRUITING
Cáceres
Hospital Universitario de Gran Canaria Doctor Negrin
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Puerta de Hierro - Majadahonda
ACTIVE_NOT_RECRUITING
Majadahonda
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Son Espases
RECRUITING
Palma De Mallorca
Complejo Hospitalario de Navarra - H. de Navarra, Hematología C/ de Irunlarrea, 3, Pamplona
RECRUITING
Pamplona
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Doctor Peset
RECRUITING
Valencia
H. Quirón Zaragoza
RECRUITING
Zaragoza
Taiwan
Chang Gung Medical Foundation - ChiaYi Chang Gung Memorial Hospital - Chiayi Branch
RECRUITING
Chiayi City
Kaohsiung Medical University - Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei City
Thailand
Ramathibodi Hospital - Mahidol University - Hematology
RECRUITING
Bangkok
Siriraj Hospital
RECRUITING
Bangkok
Thammasat University Hospital
RECRUITING
Khlong Luang
Srinagarind Hospital (KhonKaen University)
RECRUITING
Khon Kaen
Songklanagarind Hospital
RECRUITING
Songkhla
Turkey
Sakarya Research and Training Hospital
RECRUITING
Adapazarı
Ankara University Faculty of Medicine
RECRUITING
Ankara
Gazi University Medical Faculty
RECRUITING
Ankara
Pamukkale University
RECRUITING
Denizli
Gaziantep University Faculty of Medicine
RECRUITING
Gaziantep
Inonu University Turgut Ozal Medical Center
RECRUITING
Malatya
Mersin University Medical Faculty
RECRUITING
Mersin
Ondokuz Mayis University Medical Faculty - Hematology
RECRUITING
Samsun
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Birmingham
NHS Greater Glasgow and Clyde
ACTIVE_NOT_RECRUITING
Glasgow
Guy's and Saint Thomas' NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
Oxford University Hospitals NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Oxford
Contact Information
Primary
John Mei
jmei@kartosthera.com
650-542-0136
Backup
Yulia Khalina
ykhalina@kartosthera.com
908-656-2799
Time Frame
Start Date: 2019-01-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 385
Treatments
Experimental: Part A Cohort 1
KRT-232 120 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Experimental: Part A Cohort 2
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Experimental: Part A Cohort 3
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Experimental: Part A Cohort 4b
KRT-232 240 mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles)
Experimental: Part B Arm 1 KRT-232
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Active_comparator: Part B Arm 2 Best Available Therapy
Best available therapy at the discretion of the investigator, on a 28-day cycle.
Related Therapeutic Areas
Sponsors
Leads: Kartos Therapeutics, Inc.