An Open-Label, 2-Cohort, Multicenter, Phase 2 Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
This is a multicenter, open-label, 2-cohort, 2 - stage, Phase 2 study to assess the
objective response rate of E7080 in previously treated subjects with American Joint
Committee on Cancer (AJCC) unresectable stage III or stage IV melanoma and disease
progression. Cohort 1 will enroll subjects not harboring the V600E BRAF mutation with
disease progression following up to two prior systemic anticancer regimen treatments for
unresectable stage III or stage IV melanoma, Cohort 2 will enroll subjects harboring the
activating BRAF mutations (mainly the V600E mutation) with disease progression following
BRAF-V600E-targeted therapy. Eligible subjects must have measurable disease according to
Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
First dose -first documentation of disease progression or death measured every 8 weeks
No
Eisai US Medical Services
Study Director
Eisai Limited
United States: Food and Drug Administration
E7080-G000-206
NCT01136967
June 2010
Name | Location |
---|---|
Alexandria, Minnesota 56308 | |
Birmingham, Alabama 35294 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Louisville, Kentucky 40207 | |
McLean, Virginia 22101 | |
Hackensack, New Jersey 07601 | |
Denver, Colorado | |
Boston, Massachusetts | |
Eugene, Oregon | |
Milwaukee, Wisconsin | |
Lebanon, New Hampshire | |
Las Vegas, Nevada 89109 | |
Jackson, Mississippi |