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Brief Title: STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Official Title: A Single Arm, Open-label, Phase II, Multicentre Study, to Assess the Safety of Vismodegib (GDC-0449) in Patient With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)
Study ID: NCT01367665
Brief Summary: This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia, Buenos Aires, , Argentina
Premier Specialists, Kogarah, New South Wales, Australia
Skin and Cancer Foundation Australia, Westmead, New South Wales, Australia
CMAX A division of IDT Australia Limited, Adelaide, South Australia, Australia
Skin & Cancer Foundation, Carlton, Victoria, Australia
LKH Graz; Abteilung für allgemeine Dermatologie, Graz, , Austria
LKH Salzburg; Universitätsklinik für Dermatologie, Salzburg, , Austria
Landesklinikum St. Pölten, St. Pölten, , Austria
Medizinische Universität Wien; Univ.Klinik für Dermatologie, Wien, , Austria
UZ Leuven Gasthuisberg, Leuven, , Belgium
University Clinical Center of the Republic of Srpska, Banja Luka, , Bosnia and Herzegovina
Clinic of Oncology, University Clinical Center Sarajevo, Sarajevo, , Bosnia and Herzegovina
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
District Oncology Dispensary; Department for Oncology and Dermatology, Plovdiv, , Bulgaria
National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic, Sofia, , Bulgaria
Western Canada Dermatology Institute, Edmonton, Alberta, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
London Regional Cancer Centre, London, Ontario, Canada
Dr. Nowell Solish Cosmetic Dermatology, Toronto, Ontario, Canada
Victoria Park MediSpa, Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ), Quebec, , Canada
Inst. Nacional de Cancerologia; Clinica de Seno, Bogota, , Colombia
Riesgo De Fractura; Rheumatology, Bogota, , Colombia
Hemato Oncologos S.A., Cali, , Colombia
Hospital Pablo Tobon Uribe, Medellin-Antioquia, , Colombia
Reumalab Sas; Rheumatology, Medellin, , Colombia
Clinical Hospital Sisters of Mercy, Zagreb, , Croatia
Nemocnice Ceske Budejovice, Ceske Budejovice, , Czechia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology, Hradec Kralove, , Czechia
Fakultní nemocnice Ostrava; Kožní oddělení, Ostrava, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Fakultni nemocnice v Motole, Praha 5, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha, , Czechia
Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni, Praha, , Czechia
Herlev Hospital; Onkologisk afdeling, Herlev, , Denmark
Helsinki University Central Hospital; Skin & Allergy Hospital, Helsinki, , Finland
Kuopion yliopistollinen sairaala, Kuopio, , Finland
Hopital Saint Andre CHU De Bordeaux; Dermatologie, Bordeaux, , France
Hopital Ambroise Pare; Sce Dermatologie, Boulogne-billancourt, , France
Chu Site Du Bocage;Dermatologie, Dijon, , France
Hopital Claude Huriez; Sce Dermatologie, Lille, , France
Hopital Timone Adultes; Dermatologie, Marseille, , France
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie, Montpellier, , France
Hopital Hotel Dieu Et Hme; Clinique Dermatologique, Nantes, , France
Hopital Saint Louis; Dermatologie 1, Paris, , France
Centre Hospitalier Lyon Sud; Dermatologie, Pierre Benite, , France
Hôpital Larrey Université Paul Sabatier; Service Dermatologie, Toulouse, , France
Institut Gustave Roussy; Comite 5, Villejuif, , France
Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle, Berlin, , Germany
Vivantes Klinikum Spandau, Berlin, , Germany
Elbekliniken Buxtehude; Klinik für Dermatologie, Buxtehude, , Germany
Klinikum Dortmund gGmbH Klinikzentrum Mitte, Dortmund, , Germany
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie, Dresden, , Germany
Universitätsklinikum Düsseldorf; Hautklinik, Düsseldorf, , Germany
HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie, Erfurt, , Germany
Universitätsklinikum Essen, Essen, , Germany
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie, Frankfurt, , Germany
Universitätsklinikum Freiburg Universitäts-Hautklinik, Freiburg, , Germany
Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen, Greifswald, , Germany
Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie, Hamburg, , Germany
Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie, Hannover, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Klinikum am Gesundbrunnen; Tumorzentrum, Heilbronn, , Germany
Klinikum Kassel; Hautklinik, Kassel, , Germany
UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie, Kiel, , Germany
Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie, Köln, , Germany
Klinikum d.Stadt Ludwigshafen Hautklinik, Ludwigshafen, , Germany
Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik), Lübeck, , Germany
Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie, Magdeburg, , Germany
Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie, Mannheim, , Germany
Universitätsklinikum Marburg Klinik f. Dermatologie, Marburg, , Germany
Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie, Muenster, , Germany
Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie, München, , Germany
Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie, München, , Germany
Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie, Nürnberg, , Germany
Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie, Quedlinburg, , Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie, Regensburg, , Germany
Universitaets-Hautklinik Tuebingen, Tübingen, , Germany
Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie, Würzburg, , Germany
Laiko General Hospital; 1St Pathological Clinic, Athens, , Greece
Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department, Athens, , Greece
Univ General Hosp Heraklion; Medical Oncology, Heraklion, , Greece
University General Hospital of loannina; Dermatology and Venereal Diseases Clinic, Ioannina, , Greece
Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki, , Greece
Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika, Budapest, , Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly, Budapest, , Hungary
Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika, Debrecen, , Hungary
Kaposi Mor Teaching Hospital, Kaposvár, , Hungary
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp., Szeged, , Hungary
Cork University Hospital; Dermatology Dept, Cork, , Ireland
St Vincent'S Uni Hospital; Medical Oncology, Dublin, , Ireland
Rambam Medical Center, Halfa, , Israel
Hadassah University Hospital - Ein Kerem, Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus, Petach Tikva, , Israel
Sheba Medical Center; Tel Hashomer, Ramat Gan, , Israel
Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol, L'Aquila, Abruzzo, Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Policlinico Sant'Orsola Malpighi; U.O. Dermatologia, Bologna, Emilia-Romagna, Italy
I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico, Meldola, Emilia-Romagna, Italy
Azienda Ospedaliera Umberto I; Clinica Dermatologica, Roma, Lazio, Italy
Fondazione Ptv Policlinico Tor Vergata; Dermatologia, Roma, Lazio, Italy
Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica, Roma, Lazio, Italy
Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica, Roma, Lazio, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A, Genova, Liguria, Italy
Università di Brescia; Dipartimento di Dermatologia, Brescia, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo, Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milano, Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milano, Lombardia, Italy
IRCCS Istituto Clinico Humanitas; Farmacia, Rozzano, Lombardia, Italy
A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica, Ancona, Marche, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico, Candiolo, Piemonte, Italy
Ospedale Antonio Perrino; Oncologia Medica, Brindisi, Puglia, Italy
Ospedale Armando Businco; Dermatologia, Cagliari, Sardegna, Italy
Ospedale IOT- Palagi Dermatologia 2, Firenze, Toscana, Italy
A.O.U. Senese Policlinico Santa Maria Alle Scotte, Siena, Toscana, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
National Cancer Institute, Vilnius, , Lithuania
Hospital General de México, Mexico City, Mexico CITY (federal District), Mexico
Academ Ziekenhuis Groningen; Medical Oncology, Groningen, , Netherlands
LUMC; Dermatologie, Leiden, , Netherlands
Maastricht University Medical Centre; Dermatologie, Maastricht, , Netherlands
Erasmus MC; Dermatology, Rotterdam, , Netherlands
Waitemata District Health; General Surgery, Takapuna, , New Zealand
Oslo Universitetssykehus HF; Radiumhospitalet, Oslo, , Norway
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdańsk, , Poland
DERMED Centrum Medyczne; Sp zoo, Lodz, , Poland
Centrum Diagnostyki Znamion, Poznan, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna, Warsaw, , Poland
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti, Bucuresti, , Romania
Prof. Dr. I. Chiricuta Institute of Oncology, Cluj Napoca, , Romania
Oncology Center Sf. Nectarie, Craiova, , Romania
Spital Clinic Judetean Mures; Oncologie, Targu Mures, , Romania
S.C. Life Search S.R.L; Medical Oncology Clinic, Timisoara, , Romania
FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF, St Petersburg, Leningrad, Russian Federation
FSBI "National Medical Research Center of Oncology N.N. Blokhin", Moscow, , Russian Federation
Moscow city oncology hospital #62 of Moscow Healthcare Department, Moscow, , Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary, St Petersburg, , Russian Federation
Institute for Oncology and Radiology of Serbia; Medical Oncology, Belgrade, , Serbia
Military Medical Academy, Belgrade, , Serbia
Fakultna Nemocnica Roosevelta, Banska Bystrica, , Slovakia
Institute of Oncology Ljubljana, Ljubljana, , Slovenia
Hospital Univ. Central de Asturias; Servicio de Dermatologia, Oviedo, Asturias, Spain
Hospital Universitario Son Espases; Servicio de Oncologia, Palma De Mallorca, Islas Baleares, Spain
Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia, Las Palmas de Gran Canaria, LAS Palmas, Spain
Fundacion Hospital de Alcorcon; Servicio de Dermatologia, Alcorcon, Madrid, Spain
Hospital Universitario del Sureste; Servicio de Dermatologia, Arganda del Rey, Madrid, Spain
Clinica Universitaria de Navarra; Servicio de Dermatologia, Pamplona, Navarra, Spain
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia, Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Cruces; Servicio de Oncologia, Bilbao, Vizcaya, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia, Barcelona, , Spain
Hospital Clinic i Provincial; Servicio de dermatología, Barcelona, , Spain
Hospital Reina Sofia; Servicio de dermatología, Cordoba, , Spain
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia, Granada, , Spain
Hospital General Universitario de Guadalajara; Servicio de Dermatologia, Guadalajara, , Spain
Complejo Asistencial Universitario de Leon; Servicio de Oncologia, Leon, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia, Murcia, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia, Toledo, , Spain
Hospital General Universitario de Valencia; Servicio de oncologia, Valencia, , Spain
Instituto Valenciano Oncologia; Oncologia Medica, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Dermatologia, Zaragoza, , Spain
Skånes Onkologiska Klinik, Universitetssjukhuset, Lund, , Sweden
Karolinska Universitetssjukhuset, Solna, Stockholm, , Sweden
Universitätsspital Zürich; Dermatologische Klinik, Zürich, , Switzerland
Ankara Numune Training and Research Hospital; Dermatology, Ankara, , Turkey
Gazi Universitesi Tip Facultesi; Dept. of Dermatology, Ankara, , Turkey
Istanbul Uni of Medicine Faculty; Oncology Dept, Istanbul, , Turkey
Dokuz Eylul University Medicine Faculty; Dermatology, Izmir, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sıhhiye, Ankara, , Turkey
Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279, Cambridge, , United Kingdom
Western Infirmary; Division of Cardiovascular and Medical Sciences, Glasgow, , United Kingdom
St Thomas Hospital, London, , United Kingdom
Royal Marsden Hospital - London, London, , United Kingdom
Freeman Hospital; Northern Centre For Cancer Care, New Castle Upon Tyne, , United Kingdom
Salford Royal NHS Foundation Trust, Salford, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR