beenmergstoornis: MDS (myelodysplastisch syndroom/myelodysplasie) Acute myeloid leukemia cancer of the blood myelodysplastic Syndrome
Conditions
Interventions
Patients will receive diverse doses of AMG 330 per cohort during the escalation
phase.
The AMG 330 dose in the expansion phase is dependent on the MTD that is
determined during the escalation phase.
Sponsors
Amgen
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: subject incidence and grade of adverse events (AEs) and dose limiting toxicities (DLTs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the pharmacokinetics of AMG 330. Determine the formation of anti-AMG330 antibodies. | — |
Countries
Netherlands
Outcome results
None listed