A Phase Ib/II, Mulicenter, Study of LEE011 in Combination With LGX818 in Adult Patients With BRAF Mutant Melanoma.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Dose Limiting Toxicities (Phase Ib)
Dose Limiting Toxicities (DLTs) during the first 28 days of the combination treatment of LEE011 and LGX818.
Cycle 1 = 28 days
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CLEE011X2105
NCT01777776
May 2013
December 2015
Name | Location |
---|---|
Cancer Centers of the Carolinas CCC Faris | Greenville, South Carolina 29605 |
Oregon Health & Science University Dept. of OHSU (3) | Portland, Oregon 97239 |
Northwestern University Clinical Research Office (2) | Chicago, Illinois 60611 |
University of California at Los Angeles UCLA 3 | Los Angeles, California 90095 |
University of Colorado Dept of Oncology | Aurora, Colorado 80045 |
Memorial Sloan Kettering Cancer Center Dept Oncology | New York, New York 10021 |
Duke University Medical Center SC-6 | Durham, North Carolina 27710 |
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University | Columbus, Ohio 43210 |
University of California San Diego Dept of Onc | La Jolla, California 92093-0658 |
Yale University School of Medicine dept of Onc | New Haven, Connecticut 06520 |
Cancer Centers of Florida PA Cancer Centers of South Florid | Ocoee, Florida *see dep* |
Dartmouth Hitchcock Medical Center Dept Onc | Lebanon, New Hampshire 03756 |
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Dept of Oncology | Seattle, Washington 98109-1023 |