NL-OMON55859
Completed
Not Applicable
A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignancies - 20120252-Phase 1 Study of AMG330 in Subjects With Myeloid Malignancies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- beenmergstoornis: MDS (myelodysplastisch syndroom/myelodysplasie)
- Sponsor
- Amgen
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects \>\= 18 years of age, AML as defined by the WHO Classification,
- •persisting or recurring following one or more treatment courses,
- •relapsed/refractory AML: blasts in bone marrow \>5%, Eastern Cooperative
- •Oncology Group Performance Status of \<\= 2
- •Please see protocol section 4\.1 for the full list.
Exclusion Criteria
- •Known hypersensitivity to immunoglobulins or to any other component of the IP
- •formulation (eg, sucrose, 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, History or evidence of
- •cardiovascular risk, History of arterial thrombosis in the past 3 months
Outcomes
Primary Outcomes
Not specified
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