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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 14, 2011
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFebruary 3, 2014
January 1, 2014
3.4 years
January 14, 2011
January 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
1 year
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).
1 year
Secondary Outcomes (1)
Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow
1 year
Study Arms (1)
Elesclomol Sodium
EXPERIMENTALInterventions
Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Princess Margaret Hospital
Toronto, Ontario, MSG 2M9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2011
First Posted
January 21, 2011
Study Start
January 1, 2011
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
February 3, 2014
Record last verified: 2014-01