Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

Status unconfirmed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT01180426

Run by

Chroma Therapeutics

People needed

30

Starts

2010-06-01

Expected to finish

2013-06-01

Last updated by the study team

2012-02-15

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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