drugset / Trial / NCT00496223
A Phase I/II Study of Sunitinib and Dacarbazine
Phase 1/2
Terminated
11 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Pfizer · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a combination Phase I/II design that explores the toxicity and activity of Sunitinib and Dacarbazine (DTIC) for metastatic melanoma. The initial Phase I part of this trial will consist of a dose escalation of sunitinib while keeping the DTIC dose constant. If no DLT is seen, this dose will be the suggested Phase II trial dose. If less than 2 disease responses are seen, patients will not be enrolled any further, and the study will be considered negative for activity. If a clinical response is seen, patients will continue to be enrolled.
Timeline
- Start
- 2006-09
- Primary completion
- 2007-06
- Completion
- 2007-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dacarbazine | Small molecule | 1000 mg/m2 | — |
| Subject | Sunitinib | Small molecule | — | Oral |