drugset / Trial / NCT00313456
A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a single-center, open-label (sequential-group dose-escalation dose-finding) phase I study of satraplatin and docetaxel in patients who have received prior chemotherapy regimens. Once the MTD is determined, an additional 6 patients, all with chemotherapy-naïve HRPC, will be enrolled. Once a recommended dose(s) (RD(s)) for phase 2 studies has/have been determined, 6 additional patients with chemotherapy-naïve HRPC will be enrolled at the RD to further evaluate safety and efficacy.
Timeline
- Start
- 2006-03
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Satraplatin | Other / unclassified | 40 mg/m2 | Oral |
| Subject | Satraplatin | Other / unclassified | 80 mg/m2 | Oral |