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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01280786

Enrollment

Registered

2011-01-21

Start date

2011-01-31

Completion date

2014-08-31

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

AML, leukemia, relapsed or refractory AML

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.

Interventions

DRUGElesclomol Sodium

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026