Spots Global Cancer Trial Database for Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma
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Trial Identification
Brief Title: Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma
Official Title: A Randomized Phase II, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of INC280 in Adult Patients With Advanced Hepatocellular Carcinoma After Progression or Intolerance to Sorafenib Treatment
Study ID: NCT01964235
Conditions
Study Description
Brief Summary: This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib. Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding. Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).
Detailed Description: Study was cancelled by Sponsor prior to enrollment of patients.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Massachusetts General Hospital Mass General Hospital, Boston, Massachusetts, United States
Research Medical Center Onc Dept, Kansas City, Missouri, United States
Novartis Investigative Site, Kogarah, New South Wales, Australia
Novartis Investigative Site, Heidelberg, Victoria, Australia
Novartis Investigative Site, Clichy, , France
Novartis Investigative Site, LILLE Cedex, , France
Novartis Investigative Site, Montpellier Cedex 5, , France
Novartis Investigative Site, Nice Cedex 3, , France
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Würzburg, , Germany
Novartis Investigative Site, Hong Kong SAR, , Hong Kong
Novartis Investigative Site, Hong Kong, , Hong Kong
Novartis Investigative Site, Cordoba, Andalucia, Spain
Novartis Investigative Site, Bern, , Switzerland
Novartis Investigative Site, Genève, , Switzerland
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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