drugset / Trial / NCT00575978
Hydralazine as Demethylating Agent in Breast Cancer
NaSingle-groupOpen-labelHealth-services research
Summary
This study will be conducted as a phase I/II clinical trial. In addition to determining the maximum tolerated dose (MTD) of hydralazine, the phase I trial will be performed to identify unexpected toxicities that may occur when hydralazine is used in conjunction with neoadjuvant chemotherapy in normotensive women with breast cancer. Once the phase I trial is successfully completed, the phase II trial to evaluate the efficacy of hydralazine in producing a demethylation effect will begin.
Timeline
- Start
- 2004-06
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydralazine | Small molecule | 100 mg | Oral |
| Subject | Hydralazine | Small molecule | 150 mg | Oral |
| Subject | Hydralazine | Small molecule | 200 mg | Oral |
| Subject | Hydralazine | Small molecule | 225 mg | Oral |