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Brief Title: Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies
Official Title: A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies
Study ID: NCT03465540
Brief Summary: Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.
Detailed Description: This is a first-in-human (FIH), multicenter, non-randomized, open-label, phase 1 study evaluating AMG 397 administered orally once weekly, as part of a 28-day treatment cycle in adult subjects with selected relapsed or refractory hematological malignancies
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Froedtert and Med College Wisconsin, Milwaukee, Wisconsin, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Institut Paoli Calmettes, Marseille Cedex 09, , France
Institut Gustave Roussy, Villejuif, , France
Alexandra Hospital, Athens, , Greece
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, , Italy
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi, Bologna, , Italy
Ogaki Municipal Hospital, Ogaki-shi, Gifu, Japan
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR