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A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies Summary The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and/or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.
View Eligibility Criteria Eligibility Criteria Inclusion criteria: Informed consent provided 18 years or older Relapsed/refractory AML : AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML) Exclusion criteria: Active extramedullary AML in testes or central nervous system (CNS) Known hypersensitivity to immunoglobulins or to any other component of the IP formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine) Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 1 years before screening
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There are 11 Locations for this study
University of Alabama at Birmingham Birmingham Alabama, 35294, United States
Research Site Duarte California, 91010, United States
Wake Forest University Health Sciences Winston-Salem North Carolina, 27157, United States
University of Texas MD Anderson Cancer Center Houston Texas, 77030, United States
Seattle Cancer Care Alliance Seattle Washington, 98109, United States
Princess Margaret Cancer Centre Toronto Ontario, M5G 2, Canada
Universitätsklinikum Schleswig-Holstein Kiel , 24105, Germany
Klinikum der Universität München Campus Grosshadern München , 81377, Germany
Universitatsklinikum Ulm Ulm , 89081, Germany
Research Site Amsterdam , 1007 , Netherlands
Erasmus Medisch Centrum Rotterdam , 3015 , Netherlands
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