drugset / Trial / NCT00074737

Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML

NCT00074737

Phase 2 Completed 53 enrolled Eleos, Inc.
RandomizedSingle-groupOpen-labelTreatment

Summary

The principal goal of this clinical trial is to assess the ability of cenersen sodium (EL625) to improve cancer responsiveness to the established AML therapeutic agent Idarubicin used alone or in combination with Cytarabine (Ara-C). Cenersen sodium is a drug that is designed to block the effects of a protein called p53. Laboratory evidence shows that blocking p53 will make many types of cancer, including acute myelogenous leukemia (AML), more sensitive to a variety of established cancer therapeutics while making normal tissues more resistant to the toxic effects of these agents.

Timeline

Start
2004-04
Primary completion
2007-05
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cytarabine Small molecule 0 mg/m2
Comparator Cytarabine Small molecule 100 mg/m2
Comparator Cytarabine Small molecule 1000 mg/m2
Comparator Idarubicin Small molecule
Comparator cenersen Antisense oligonucleotide