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Spots Global Cancer Trial Database for Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

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Trial Identification

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

Study Description

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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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