drugset / Trial / NCT00496444
Azacytidine and Valproic Acid in Patients With Advanced Cancers
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary Objective: 1\. To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in patients with advanced cancer. Secondary Objectives: 1. To perform a preliminary assessment of the histone acetylation and DNA methylation effects of this combination on peripheral blood mononuclear cells (PBMC). 2. To assess the clinical anti-tumor activity (objective response including complete and partial responses) of this combination in patients with advanced cancer, in a descriptive fashion.
Timeline
- Start
- 2005-05
- Primary completion
- 2009-10
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 20 mg/m2 | Subcutaneous |
| Subject | Valproic Acid | Small molecule | 10 mg/kg | Oral |