A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia
This aim of this study is to determine the safety and tolerability of elesclomol sodium at
escalating doses (ultimately identifying the maximum tolerated dose) when administered to
patients with advanced myeloid leukemia.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
- Characterize the safety and tolerability of elesclomol sodium administered to subjects with relapsed or refractory acute myeloid leukemia (AML)
1 year
Yes
United States: Food and Drug Administration
Synta 4783-14
NCT01280786
January 2011
September 2012
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |