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Spots Global Cancer Trial Database for STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

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Trial Identification

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

Interventions

vismodegib

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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