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KRT-232 and TKI Study in Chronic Myeloid Leukemia
Sponsor: Kartos Therapeutics, Inc.
Summary
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.
Official title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
109
Start Date
2021-05-07
Completion Date
2026-06-30
Last Updated
2022-03-21
Healthy Volunteers
No
Conditions
Interventions
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Dasatinib
Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.
Nilotinib
Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.
Locations (26)
University of Alabama Birmingham
Birmingham, Alabama, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Texas Oncology- Sammons CC at Baylor
Dallas, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Centre Leon Berard
Lyon, France
APHM Hopital de la Timone
Marseille, France
Institut Paoli-Calmettes
Marseille, France
Centre Hospitalier Lyon Sud
Saint-Genis-Laval, France
Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda
Milan, MI, Italy
Azienda Ospedaliero - Universitaria Mater Domini
Catanzaro, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola FC, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Pratia Onkologia Katowice
Katowice, Poland
National Medical Research Center of Hematology
Moscow, Russia
Almazov National Medical Research Center
Saint Petersburg, Russia
Samara State Medical University
Samara, Russia
Kyungpook National University Hospital
Daegu, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Clínica Universidad de Navarra
Madrid, Navarre, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain