Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia
This trial is active, not recruiting.
|Condition||acute myeloid leukemia|
|Start date||June 2010|
|End date||June 2013|
|Trial size||30 participants|
|Trial identifier||NCT01180426, CHR-2797-045|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Los Angeles, CA||UCLA Division of Hematology/Oncology||no longer recruiting|
|Ann Arbor, MI||University of Michigan||no longer recruiting|
|Hackensack, NJ||John Theurer Cancer Center||no longer recruiting|
|New York, NY||New York Presbyterian Hospitacl||no longer recruiting|
|Durham, NC||Duke University Medical Center||no longer recruiting|
|Houston, TX||MD Anderson||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Safety and Tolerability of extended treatment with tosedostat
time frame: Protocol mandated visits every 12 weeks
Efficacy of extended treatment with tosedostat
time frame: Protocol-mandated visits every 12 weeks
Male or female participants at least 60 years old.
Inclusion Criteria: - 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. Exclusion Criteria: - 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.
|Official title||The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat|
|Description||Extension protocol to the OPAL Study (CHR-2797-038). 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.|
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