A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies

Stopped early · Phase 1

Conditions studied: Relapsed/Refractory AML, Minimal Residual Disease Positive AML, Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT02520427

Run by

Amgen

People needed

95

Starts

2015-08-31

Expected to finish

2022-01-09

Last updated by the study team

2024-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Research Site — Duarte, California, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany
• Klinikum der Universität München Campus Grosshadern — München, Germany
• Universitatsklinikum Ulm — Ulm, Germany
• Research Site — Amsterdam, Netherlands
• Erasmus Medisch Centrum — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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