drugset / Trial / NCT00074737
Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |