Overview

This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatment elesclomol sodium
Phase phase 1
Sponsor Synta Pharmaceuticals Corp.
Start date January 2011
End date June 2014
Trial size 36 participants
Trial identifier NCT01280786, Synta 4783-14

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
elesclomol sodium
Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.

Primary Outcomes

Measure
Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
time frame: 1 year
Measurement of study drug concentrations to characterize pharmacokinetics.
time frame: 1 year

Secondary Outcomes

Measure
Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Synta Pharmaceuticals Corp..