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Brief Title: Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy
Official Title: A Phase 3, Randomized, Double-Blind Study of Tivantinib (ARQ 197) in Subjects With MET Diagnostic-High Inoperable Hepatocellular Carcinoma Treated With One Prior Systemic Therapy
Study ID: NCT01755767
Brief Summary: The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.
Detailed Description: Expression of c-Met in tumors correlates with aggressive hepatocellular carcinoma (HCC) features. Overexpression of the receptor in tumor samples or high level of blood HGF in subjects is related to higher recurrence rate after surgery for HCC, while high c-Met expression correlates with shorter survival in HCC subjects. In summary, c-Met holds an important prognostic role in the natural history of HCC. This Phase 3 study in MET Diagnostic-High inoperable HCC subjects has been designed based on the results from the randomized, controlled Phase 2 study conducted by ArQule, Inc. with tivantinib versus placebo in subjects with MET Diagnostic-High inoperable HCC who have failed one prior systemic therapy, mentioned above. The purpose of this study is to confirm the efficacy of tivantinib in MET Diagnostic-High HCC subjects who were previously treated with one systemic therapy, and to further evaluate the safety profile of the experimental drug in this subject population.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Tucson, Arizona, United States
, Los Angeles, California, United States
, Orange, California, United States
, Washington, District of Columbia, United States
, Gainesville, Florida, United States
, Chicago, Illinois, United States
, Westwood, Kansas, United States
, New Orleans, Louisiana, United States
, Scarborough, Maine, United States
, Boston, Massachusetts, United States
, Detroit, Michigan, United States
, Minneapolis, Minnesota, United States
, Hackensack, New Jersey, United States
, New York, New York, United States
, Philadelphia, Pennsylvania, United States
, Charleston, South Carolina, United States
, Dallas, Texas, United States
, Galveston, Texas, United States
, Houston, Texas, United States
, Seattle, Washington, United States
, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
, Buenos Aires, Caba, Argentina
, Pilar, , Argentina
, Camperdown, New South Wales, Australia
, Heidelberg, Victoria, Australia
, Melbourne, Victoria, Australia
, Nedlands, Western Australia, Australia
, Graz, , Austria
, Innsbruck, , Austria
, Linz, , Austria
, Wien, , Austria
, Brussels, , Belgium
, Ghent, , Belgium
, Leuven, , Belgium
, Liege, , Belgium
, Porto Alegre, RS, Brazil
, Sao Paulo, SP, Brazil
, Barretos, , Brazil
, Rio de Janeiro, , Brazil
, Vancouver, British Columbia, Canada
, Toronto, Ontario, Canada
, Amiens Cedex 1, , France
, Bordeaux Cedex, , France
, Caen Cedex 09, , France
, Clichy, , France
, Creteil, , France
, Grenoble, , France
, Lille Cedex, , France
, Marseille Cedex 09, , France
, Montpellier, , France
, Paris Cedex 12, , France
, Paris Cedex, , France
, Reims Cedex, , France
, Rennes Cedex, , France
, Toulouse Cedex 09, , France
, Villejuif Cedex, , France
, Aachen, , Germany
, Berlin, , Germany
, Bonn, , Germany
, Duesseldorf, , Germany
, Essen, , Germany
, Frankfurt am Main, , Germany
, Hamburg, , Germany
, Hannover, , Germany
, Heidelberg, , Germany
, Leipzig, , Germany
, Magdeburg, , Germany
, Mainz, , Germany
, Muenchen, , Germany
, Munich, , Germany
, Regensburg, , Germany
, Tuebingen, , Germany
, Ulm, , Germany
, Wuerzburg, , Germany
, Meldola, Forli-Cesena, Italy
, Rozzano, Milano, Italy
, Orbassano (TO), Torino, Italy
, Benevento, , Italy
, Bergamo, , Italy
, Bologna, , Italy
, Catania, , Italy
, Firenze, , Italy
, Milano, , Italy
, Modena, , Italy
, Napoli, , Italy
, Padova, , Italy
, Parma, , Italy
, Pavia, , Italy
, Pisa, , Italy
, Reggio Emilia, , Italy
, Roma, , Italy
, Turin, , Italy
, Amsterdam, , Netherlands
, Auckland, , New Zealand
, Lisboa, , Portugal
, Porto, , Portugal
, Vila Real, , Portugal
, Santiago de Compostela, A Coruña, Spain
, Oviedo, Asturias, Spain
, Majadahonda, Madrid, Spain
, Pamplona, Navarra, Spain
, Alicante, , Spain
, Barcelona, , Spain
, Cordoba, , Spain
, Madrid, , Spain
, Sabadell, , Spain
, Santander, , Spain
, Valencia, , Spain
, Zaragoza, , Spain
, Gothenburg, , Sweden
, Stockholm, , Sweden
, Bern, , Switzerland
, Zurich, , Switzerland
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR