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Brief Title: Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.
Official Title: A Randomized Phase III, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Everolimus (RAD001) in Adult Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment - The EVOLVE-1 Study
Study ID: NCT01035229
Brief Summary: The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, United States
Compassionate Cancer Care Medical Group CCCMG, Fountain Valley, California, United States
University of California San Diego - Moores Cancer Center SC - 3, La Jolla, California, United States
California Pacific Medical Center California Pacific Med, San Francisco, California, United States
Rocky Mountain Cancer Centers RMCC - Denver-Midtown (4), Greenwood Village, Colorado, United States
Queen's Medical Center Queens Cancer Center, Honolulu, Hawaii, United States
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU, Baltimore, Maryland, United States
Massachusetts General Hospital Dept. of Mass General Hospital, Boston, Massachusetts, United States
Midwest Cancer Care Physicians Research Medical Center, Kansas City, Missouri, United States
VA Sierra Nevada Health Care System Dept. of VA Sierra Nevada HCS, Reno, Nevada, United States
University of Rochester Medical Center Rochester, Rochester, New York, United States
Northwest Cancer Specialists Rose Quarter Cancer Center, Portland, Oregon, United States
St. Luke's Hospital and Health Network St. Luke's Cancer Network (2), Bethlehem, Pennsylvania, United States
Texas Cancer Center - Abilene, Abilene, Texas, United States
Methodist Charlton Cancer Center Methodist, Dallas, Texas, United States
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3), Dallas, Texas, United States
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio, San Antonio, Texas, United States
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care, Roanoke, Virginia, United States
University of Washington Cancer Care SC, Seattle, Washington, United States
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Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR