JPRN-jRCT2071210044
Suspended
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed/Refractory AML, Minimal Residual Disease Positive AML, Myelodysplastic Syndrome
- Sponsor
- Contact Local
- Enrollment
- 256
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Informed consent provided
- •2\. 18 years or older
- •3\. 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
- •1\. Active extramedullary AML in testes or central nervous system (CNS)
- •2\. Known hypersensitivity to immunoglobulins or to any other component of the IP formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine)
- •3\. Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for more than 1 years before screening
Outcomes
Primary Outcomes
Not specified
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