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
Completed
- Conditions
- beenmergstoornis: MDS (myelodysplastisch syndroom/myelodysplasie)Acute myeloid leukemiacancer of the bloodmyelodysplastic Syndrome10024324
- Registration Number
- NL-OMON55859
- Lead Sponsor
- Amgen
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: subject incidence and grade of adverse events (AEs) and dose limiting<br /><br>toxicities (DLTs)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Evaluate the pharmacokinetics of AMG 330.<br /><br>Determine the formation of anti-AMG330 antibodies.</p><br>