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

Synta Pharmaceuticals Corp.36 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

Elesclomol SodiumDRUG

Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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)

Time frame: 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).

Time frame: 1 year

Secondary Outcomes

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).

Time frame: 1 year

Data from ClinicalTrials.gov

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