Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia|
- Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]- Characterize the safety and tolerability of elesclomol sodium administered to subjects with relapsed or refractory acute myeloid leukemia (AML)
- Measurement of study drug concentrations to characterize pharmacokinetics. [ Time Frame: 1 year ] [ Designated as safety issue: No ]- Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML).
- Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow [ Time Frame: 1 year ] [ Designated as safety issue: No ]- Determine the optimal Phase II dose and preliminary activity for elesclomol sodium in subjects with acute myeloid leukemia (AML).
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|Experimental: Elesclomol Sodium||
Drug: Elesclomol Sodium
Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.
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.