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

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ClinicalTrials.gov Identifier: NCT01280786
Recruitment Status : Unknown
Verified January 2014 by Synta Pharmaceuticals Corp..
Recruitment status was:  Active, not recruiting
First Posted : January 21, 2011
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Elesclomol Sodium Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : August 2014


Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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)

  2. 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 :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280786


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

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01280786     History of Changes
Other Study ID Numbers: Synta 4783-14
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms