Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia
The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat
1 other identifier
interventional
30
1 country
6
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2010
Typical duration for phase_2
6 active sites
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
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 5, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 15, 2012
February 1, 2012
3 years
August 5, 2010
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of extended treatment with tosedostat
Primary outcome will be assessed using the following procedures/data: * Physical exams * Vital signs * Electrocardiography * Laboratory parameters (hematology, chemistry, urinalysis) * Adverse events * Serious adverse events
Protocol mandated visits every 12 weeks
Secondary Outcomes (1)
Efficacy of extended treatment with tosedostat
Protocol-mandated visits every 12 weeks
Study Arms (1)
Tosedostat
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Signed, informed consent
- Completion of Visit 11 in the OPAL Study (Month 6 Visit)
- Investigator's opinion that the subject would benefit from continued therapy with tosedostat.
You may not qualify if:
- Any co-existing medical condition that in the Investigator's opinion will substantially increase the risk associated with the subject's participation in the study
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Administration of any (other) investigational agent within 14 days of entry into TOPAZ.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
UCLA Division of Hematology/Oncology
Los Angeles, California, 90095, United States
University of Michigan
Ann Arbor, Michigan, 48109-2800, United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
New York Presbyterian Hospitacl
New York, New York, 10021, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MD Anderson
Houston, Texas, 77030-4009, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2010
First Posted
August 12, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
February 15, 2012
Record last verified: 2012-02