Back to resultsStudy Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Elesclomol Sodium
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, leukemia, relapsed or refractory AML
Eligibility 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
Sites / Locations
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Elesclomol Sodium
Arm Description
Outcomes
Primary Outcome Measures
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)
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01280786
First Posted
January 14, 2011
Last Updated
January 31, 2014
Sponsor
Synta Pharmaceuticals Corp.
1. Study Identification
Unique Protocol Identification Number
NCT01280786
Brief Title
Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title
A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synta Pharmaceuticals Corp.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, leukemia, relapsed or refractory AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elesclomol Sodium
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Elesclomol Sodium
Intervention Description
Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.
Primary Outcome Measure Information:
Title
Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
Description
- Characterize the safety and tolerability of elesclomol sodium administered to subjects with relapsed or refractory acute myeloid leukemia (AML)
Time Frame
1 year
Title
Measurement of study drug concentrations to characterize pharmacokinetics.
Description
- Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow
Description
- Determine the optimal Phase II dose and preliminary activity for elesclomol sodium in subjects with acute myeloid leukemia (AML).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
MSG 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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