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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01280786
First received: January 14, 2011
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]
    - 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 ] [ Designated as safety issue: No ]
    - 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 ] [ Designated as safety issue: No ]
    - 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280786

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

No publications provided

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01280786     History of Changes
Other Study ID Numbers: Synta 4783-14
Study First Received: January 14, 2011
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 15, 2014