drugset / Trial / NCT00609011
Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, dose finding, multiple-dose study in subjects with metastatic melanoma. Three dose levels of MPC-6827 will be administered with temozolomide to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, determination of dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with temozolomide.
Timeline
- Start
- 2008-03
- Primary completion
- 2009-08
- Completion
- 2009-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Verubulin | Small molecule | 2.1 mg/m2 | Intravenous |
| Subject | Verubulin | Small molecule | 2.7 mg/m2 | Intravenous |
| Subject | Verubulin | Small molecule | 3.3 mg/m2 | Intravenous |
| Background | Temozolomide | Small molecule | 85 mg/m2 | Oral |