Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia
NCT ID: NCT01180426
Last Updated: 2012-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2010-06-30
2013-06-30
Brief Summary
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Detailed Description
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Study mimics normal clinical practice; few procedures and visits are therefore mandated by the protocol. Timing of bone marrow assessment is also left at the investigator's discretion.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tosedostat
CHR-2797
120mg once daily oral for 48 weeks
Interventions
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CHR-2797
120mg once daily oral for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* Completion of Visit 11 in the OPAL Study (Month 6 Visit)
* Investigator's opinion that the subject would benefit from continued therapy with tosedostat.
Exclusion Criteria
* 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.
60 Years
ALL
No
Sponsors
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Chroma Therapeutics
INDUSTRY
Responsible Party
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Locations
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UCLA Division of Hematology/Oncology
Los Angeles, California, United States
University of Michigan
Ann Arbor, Michigan, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
New York Presbyterian Hospitacl
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
MD Anderson
Houston, Texas, United States
Countries
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Other Identifiers
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CHR-2797-045
Identifier Type: -
Identifier Source: org_study_id
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