Spots Global Cancer Trial Database for Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma
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Trial Identification
Brief Title: Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma
Official Title: A Phase 1 Open Label/ Phase 2 Randomized, Double-blind, Multicenter Study Investigating the Combination of RAD001 and Sorafenib (Nexavar®) in Patients With Advanced Hepatocellular Carcinoma
Study ID: NCT00828594
Conditions
Study Description
Brief Summary: Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD) Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Medical Center, Duarte, California, United States
UCLA Department of Medicine, Los Angeles, California, United States
Duke University, Durham, North Carolina, United States
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Barcelona, , Spain
Novartis Invstigative Site, Madrid, , Spain
Novartis Investigative Site, Tainan, , Taiwan
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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