Overview

This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatment chr-2797
Phase phase 2
Target BCL-2
Sponsor Chroma Therapeutics
Start date June 2010
End date June 2013
Trial size 30 participants
Trial identifier NCT01180426, CHR-2797-045

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
chr-2797
120mg once daily oral for 48 weeks

Primary Outcomes

Measure
Safety and Tolerability of extended treatment with tosedostat
time frame: Protocol mandated visits every 12 weeks

Secondary Outcomes

Measure
Efficacy of extended treatment with tosedostat
time frame: Protocol-mandated visits every 12 weeks

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Chroma Therapeutics.