Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Study Overview
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Brief Summary
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This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.

Detailed Description
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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.

Official Title
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A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Elesclomol Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with cytologically confirmed Acute Myeloid Leukemia (AML) that has relapsed after the completion of induction and/or consolidation therapy or has failed to respond to standard induction therapy ECOG performance status of 0-2 Acceptable organ and marrow function during the screening period as defined by the protocol Reliable venous access suitable for study drug infusions Exclusion Criteria: Significant cardiovascular disease Candidates for hematopoietic stem cell transplant Women who are pregnant or breast-feeding Prior treatment with chronic immunosuppressants Other clinically significant uncontrolled conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elesclomol Sodium<br> | Drug: Elesclomol Sodium<br>* Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Measurement of study drug concentrations to characterize pharmacokinetics. | - Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow | - Determine the optimal Phase II dose and preliminary activity for elesclomol sodium in subjects with acute myeloid leukemia (AML). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, leukemia, relapsed or refractory AML