Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280786
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, MSG 2M9|