An Expanded Cohort Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma
NCT01078961 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2016-06-08
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.
Conditions
Interventions
- DRUG
-
Given intravenously on days 1, 8 and 15 of each 28 day cycle
- DRUG
-
400mg taken orally twice a day
Sponsors & Collaborators
- collaborator OTHER
-
Beth Israel Deaconess Medical Center
collaborator OTHER -
Brigham and Women's Hospital
collaborator OTHER - collaborator INDUSTRY
-
Millennium Pharmaceuticals, Inc.
collaborator INDUSTRY -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Ryan J. Sullivan, MD · Massachusetts General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-09-30
- Primary Completion
- 2013-02-28
- Completion
- 2016-06-30
Countries
- United States
Study Locations
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