Status:
UNKNOWN
Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
Chroma Therapeutics
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01180426
Start Date
June 1 2010
End Date
June 1 2013
Last Update
February 15 2012
Active Locations (6)
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1
UCLA Division of Hematology/Oncology
Los Angeles, California, United States, 90095
2
University of Michigan
Ann Arbor, Michigan, United States, 48109-2800
3
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
4
New York Presbyterian Hospitacl
New York, New York, United States, 10021