drugset / Trial / NCT01078961
An Expanded Cohort Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma
Phase 1
Completed
11 enrolled
Massachusetts General Hospital
Bayer · collabBeth Israel Deaconess Medical Center · collabBrigham and Women's Hospital · collabDana-Farber Cancer Institute · collabMillennium Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This research study involves the use of two investigational drugs: sorafenib and bortezomib. Sorafenib is designed to stop the growth of cells caused by changes associated with cancer. Bortezomib is designed to stop cancer cells from getting rid of waste products. This causes the cells to build up toxic levels of waste that leads to cell death. In the laboratory, the combination of sorafenib and bortezomib has been shown to fight cancer cells better than either drug alone. We are looking to determine if the combination of sorafenib and bortezomib is a safe treatment for patients with advanced melanoma. The effectiveness of this combination will also be assessed.
Timeline
- Start
- 2010-09
- Primary completion
- 2013-02
- Completion
- 2016-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |