Acute Myeloid Leukemia Clinical Trial

Clinical Trial Finder Acute Myeloid Leukemia Trials

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

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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.

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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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

96

Study ID:

NCT02520427

Recruitment Status:

Terminated

Sponsor:

Amgen

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There are 11 Locations for this study

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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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How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

96

Study ID:

NCT02520427

Recruitment Status:

Terminated

Sponsor:


Amgen

How clear is this clinincal trial information?

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