Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT01280786|
Recruitment Status : Unknown
Verified January 2014 by Synta Pharmaceuticals Corp..
Recruitment status was: Active, not recruiting
First Posted : January 21, 2011
Last Update Posted : February 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Elesclomol Sodium||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||August 2014|
|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.
- Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability. [ Time Frame: 1 year ]- 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 ]- 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 ]- Determine the optimal Phase II dose and preliminary activity for elesclomol sodium in subjects with acute myeloid leukemia (AML).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280786
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, MSG 2M9|