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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Synta Pharmaceuticals Corp..
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp. Identifier:
First received: January 14, 2011
Last updated: January 31, 2014
Last verified: January 2014
This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.

Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Elesclomol Sodium
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Resource links provided by NLM:

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability. [ Time Frame: 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. [ Time Frame: 1 year ]
    - Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML).

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

Estimated Enrollment: 36
Study Start Date: January 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elesclomol Sodium Drug: Elesclomol Sodium
Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01280786

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, MSG 2M9
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

Responsible Party: Synta Pharmaceuticals Corp. Identifier: NCT01280786     History of Changes
Other Study ID Numbers: Synta 4783-14
Study First Received: January 14, 2011
Last Updated: January 31, 2014

Keywords provided by Synta Pharmaceuticals Corp.:
relapsed or refractory AML

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms processed this record on May 25, 2017