Acute Myeloid Leukemia Clinical Trial
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.
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
Birmingham Alabama, 35294, United States
Duarte California, 91010, United States
Winston-Salem North Carolina, 27157, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Toronto Ontario, M5G 2, Canada
Kiel , 24105, Germany
München , 81377, Germany
Ulm , 89081, Germany
Amsterdam , 1007 , Netherlands
Rotterdam , 3015 , Netherlands
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