Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chroma Therapeutics
• Treatments: Tosedostat

Criteria

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.