A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, whichever occurs first. PFS will be determined by a Blinded Independent Review Committee (BIRC). The local Investigator's assessments will be used as supportive analyses.
The final PFS analysis is expected approximately 16 months after FPFV.
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CMEK162A2301
NCT01763164
July 2013
May 2016
Name | Location |
---|---|
USC/Kenneth Norris Comprehensive Cancer Center | Los Angeles, California 90033 |
US Oncology Central Monitoring | Dallas, Texas 75246 |
Kaiser Permanente Northwest Dept of Kaiser Northwest (3) | Portland, Oregon 97227 |
Comprehensive Cancer Centers of Nevada CCC of Nevada (1) | Las Vegas, Nevada 89109 |
Methodist Cancer Center Methodist Estabrook | Omaha, Nebraska 68114 |
Sarah Cannon Research Institute SC - 2 | Chattanooga, Tennessee 37404 |
University of South Alabama / Mitchell Cancer Institute SC | Mobile, Alabama 36688 |
Highlands Oncology Group SC | Fayetteville, Arkansas 72703 |
Beverly Hills Cancer Center SC | Beverly HIlls, California 90211 |
California Pacific Medical Center SC | San Francisco, California 94115 |
Stanford University Medical Center SC - 3 | Stanford, California 94304 |
University of Colorado Dept of Oncology | Aurora, Colorado 80045 |
Florida Cancer Specialists Dept of Onc | Fort Myers, Florida 33901 |
Florida Cancer Specialists SC | Fort Myers, Florida 33901 |
Palm Beach Cancer Institute SC-2 | West Palm Beach, Florida 33401 |
Oncology Specialists, SC SC - 5 | Park Ridge, Illinois 60068-0736 |
Goshen Health System Center for Cancer Care SC | Goshen, Indiana 46526 |
University of Iowa Hospitals & Clinics Oncology | Iowa City, Iowa 52242 |
Eastern Maine Medical Center Research Center SC | Bangor, Maine 04401 |
Weinberg Cancer Institute at Franklin Square Hospital Dept of Oncology | Baltimore, Maryland 21237-3998 |
Massachusetts General Hospital SC -6 | Boston, Massachusetts 02114 |
Wayne State University/Karmanos Cancer Institute SC - 1 | Detroit, Michigan 48201 |
University of Minnesota Medical Center SC | Minneapolis, Minnesota 55455 |
Minnesota Oncology Hematology, P.A. Fridley Location | Minneapolis, Minnesota 55404 |
Mercy Medical Research Institute SC-1 | Manchester, Missouri 63021 |
Cooper Cancer Center SC | Camden, New Jersey 08103 |
Hackensack University Medical Center SC-2 | Hackensack, New Jersey 07601 |
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 |
Oregon Health & Science University SC-7 | Portland, Oregon 97239 |
Northwest Cancer Specialists Compass Oncology - SC | Portland, Oregon 97210 |
St. Luke's Hospital and Health Network SC | Bethlehem, Pennsylvania |
Penn State University / Milton S. Hershey Medical Center SC-2 | Hershey, Pennsylvania 17033-0850 |
Thomas Jerfferson University Hospital SC | Philadelphia, Pennsylvania 19107-5098 |
University of Pennsylvania Medical Center SC - 2 | Philadephia, Pennsylvania 19104 |
University of Pittsburgh Medical Center SC-4 | Pittsburgh, Pennsylvania |
Baylor College of Medicine Oncology | Dallas, Texas 75246 |
University of Texas Southwestern Medical Center SC (5) | Dallas, Texas 75390-8527 |
University of Texas Health Science Center at Houston SC | Houston, Texas 77030 |