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

Phase 1

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Elesclomol Sodium

• Registration Number: NCT01280786
• Lead Sponsor: Synta Pharmaceuticals Corp.

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-21
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03
• Primary Completion: 2014-06
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elesclomol Sodium	Elesclomol Sodium	-

Primary Outcome Measures

Name	Time	Method
Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.	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.	1 year	- Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada