Spots Global Cancer Trial Database for A Randomized, Placebo-controlled, Double-blind Phase 2 Study With OSI-906 in Patients With Advanced HCC
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Trial Identification
Brief Title: A Randomized, Placebo-controlled, Double-blind Phase 2 Study With OSI-906 in Patients With Advanced HCC
Official Title: A Randomized, Placebo-controlled, Double-blinded Phase 2 Study of Second-line Treatment With OSI-906 in Patients With Advanced Hepatocellular Carcinoma (HCC) After Failure of First-line Treatment With Sorafenib
Study ID: NCT01101906
Conditions
Study Description
Brief Summary: This is a randomized, placebo-controlled, double-blind phase 2 study of OSI-906 or placebo at a continuous 150 mg twice daily (BID) dose.
Detailed Description: Adult patients with advanced HCC previously treated with sorafenib will be randomized 2:1 to receive either single agent OSI-906 or placebo
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California - Los Angeles, Los Angeles, California, United States
Tulane University Health Services Center, New Orleans, Louisiana, United States
Oregon Health & Science University, Portland, Oregon, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Seattle Cancer Care Alliance University of Washington, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cliniques Universitaires Saint-Luc, Brussells, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Hopital Jean Verdier - Dervice d'Hepato-Gastroenterologie, Bondy Cedex, , France
Hôpital Henri Mondor, Creteil cedex, , France
Hopital de la Timone, Marseille Cedex 5, , France
Hopital l'Archet 2, Nice cedex 03, , France
Hôpital Saint-Antoine, Paris cedex 12, , France
Hôpital de Tenon, Paris cedex 12, , France
Centre Rene Gauducheau, Saint Herblain cedex, , France
Universitatsklinikum Essen, Essen, , Germany
Universitätsklinikum Halle, Halle, , Germany
Universitatsklinikum des Saarlandes, Homburg, , Germany
Universitätsklinikum Magdeburg A.ö.R., Magdeburg, , Germany
Queen Mary Hospital, Hong Kong, , Hong Kong
Fondazione Ca' Granda Ospedale Maggiore Policlinico, Divisione di Gastroenterologia I, Milano, , Italy
Ospedale Fatebenefratelli, Dipartimento Medicina Interna, Napoli, , Italy
IRCCS Istituto Nazionale per lo studio e la cura dei tumori Fondazione G. Pascale-SSD Epatobiliare, Napoli, , Italy
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ISMETT-Dipartimento di Epatologia e Gastroenterologia, Palermo, , Italy
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Singapore General Hospital, Singapore, , Singapore
Johns Hopkins Singapore International Medical Centre, Singapore, , Singapore
Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Coruna, Spain
Hospital Clinic Provincial, Barcelona, , Spain
Hospital Puerta de Hierro Majadahonda, Madrid, , Spain
Clinica Universitaria de Navarra, Pamplona, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Chang Gung Medical Foundation LinKou Branch, TaoYuan, , Taiwan
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR
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