Clinical trial NCT01367665: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Basal Cell Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 1232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

* Concurrent anti-tumor therapy
* Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment
* Uncontrolled medical illness

Primary outcomes:
measure: Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs)
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
measure: Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
measure: Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
measure: Exposure to Study Treatment: Duration on Treatment
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
measure: Exposure to Study Treatment - Dose Intensity
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Secondary outcomes:
measure: Best Overall Response Rate (BORR)
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
measure: Duration of Response
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
measure: Time to Response
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
measure: Overall Survival (OS)
timeFrame: Baseline to the data cut-off of 14 June 2017 (up to 6 years)
measure: Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom
timeFrame: Baseline to the data cut-off date of 14 June 2017 (up to 6 years).
measure: Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale
timeFrame: 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).
measure: Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale
timeFrame: 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia
city: Kogarah
country: Australia
facility: Premier Specialists
state: New South Wales
city: Westmead
country: Australia
facility: Skin and Cancer Foundation Australia
state: New South Wales
city: Adelaide
country: Australia
facility: CMAX A division of IDT Australia Limited
state: South Australia
city: Carlton
country: Australia
facility: Skin & Cancer Foundation
state: Victoria
city: Graz
country: Austria
facility: LKH Graz; Abteilung für allgemeine Dermatologie
city: Salzburg
country: Austria
facility: LKH Salzburg; Universitätsklinik für Dermatologie
city: St. Pölten
country: Austria
facility: Landesklinikum St. Pölten
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Oncology, University Clinical Center Sarajevo
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Plovdiv
country: Bulgaria
facility: District Oncology Dispensary; Department for Oncology and Dermatology
city: Sofia
country: Bulgaria
facility: National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic
city: Edmonton
country: Canada
facility: Western Canada Dermatology Institute
state: Alberta
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Dr. Nowell Solish Cosmetic Dermatology
state: Ontario
city: Montreal
country: Canada
facility: Victoria Park MediSpa
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)
city: Bogota
country: Colombia
facility: Inst. Nacional de Cancerologia; Clinica de Seno
city: Bogota
country: Colombia
facility: Riesgo De Fractura; Rheumatology
city: Cali
country: Colombia
facility: Hemato Oncologos S.A.
city: Medellin-Antioquia
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Medellin
country: Colombia
facility: Reumalab Sas; Rheumatology
city: Zagreb
country: Croatia
facility: Clinical Hospital Sisters of Mercy
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
city: Ostrava
country: Czechia
facility: Fakultní nemocnice Ostrava; Kožní oddělení
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha
country: Czechia
facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni
city: Herlev
country: Denmark
facility: Herlev Hospital; Onkologisk afdeling
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital; Skin & Allergy Hospital
city: Kuopio
country: Finland
facility: Kuopion yliopistollinen sairaala
city: Bordeaux
country: France
facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie
city: Boulogne-billancourt
country: France
facility: Hopital Ambroise Pare; Sce Dermatologie
city: Dijon
country: France
facility: Chu Site Du Bocage;Dermatologie
city: Lille
country: France
facility: Hopital Claude Huriez; Sce Dermatologie
city: Marseille
country: France
facility: Hopital Timone Adultes; Dermatologie
city: Montpellier
country: France
facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique
city: Paris
country: France
facility: Hopital Saint Louis; Dermatologie 1
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud; Dermatologie
city: Toulouse
country: France
facility: Hôpital Larrey Université Paul Sabatier; Service Dermatologie
city: Villejuif
country: France
facility: Institut Gustave Roussy; Comite 5
city: Berlin
country: Germany
facility: Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau
city: Buxtehude
country: Germany
facility: Elbekliniken Buxtehude; Klinik für Dermatologie
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH Klinikzentrum Mitte
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf; Hautklinik
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg Universitäts-Hautklinik
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Heilbronn
country: Germany
facility: Klinikum am Gesundbrunnen; Tumorzentrum
city: Kassel
country: Germany
facility: Klinikum Kassel; Hautklinik
city: Kiel
country: Germany
facility: UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
city: Köln
country: Germany
facility: Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie
city: Ludwigshafen
country: Germany
facility: Klinikum d.Stadt Ludwigshafen Hautklinik
city: Lübeck
country: Germany
facility: Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie
city: Mannheim
country: Germany
facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg Klinik f. Dermatologie
city: Muenster
country: Germany
facility: Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie
city: München
country: Germany
facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
city: Quedlinburg
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
city: Tübingen
country: Germany
facility: Universitaets-Hautklinik Tuebingen
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
city: Athens
country: Greece
facility: Laiko General Hospital; 1St Pathological Clinic
city: Athens
country: Greece
facility: Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department
city: Heraklion
country: Greece
facility: Univ General Hosp Heraklion; Medical Oncology
city: Ioannina
country: Greece
facility: University General Hospital of loannina; Dermatology and Venereal Diseases Clinic
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki; Oncology Department
city: Budapest
country: Hungary
facility: Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika
city: Kaposvár
country: Hungary
facility: Kaposi Mor Teaching Hospital
city: Szeged
country: Hungary
facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
city: Cork
country: Ireland
facility: Cork University Hospital; Dermatology Dept
city: Dublin
country: Ireland
facility: St Vincent'S Uni Hospital; Medical Oncology
city: Halfa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Ramat Gan
country: Israel
facility: Sheba Medical Center; Tel Hashomer
city: L'Aquila
country: Italy
facility: Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol
state: Abruzzo
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
state: Campania
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi; U.O. Dermatologia
state: Emilia-Romagna
city: Meldola
country: Italy
facility: I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera Umberto I; Clinica Dermatologica
state: Lazio
city: Roma
country: Italy
facility: Fondazione Ptv Policlinico Tor Vergata; Dermatologia
state: Lazio
city: Roma
country: Italy
facility: Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica
state: Lazio
city: Roma
country: Italy
facility: Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica
state: Lazio
city: Genova
country: Italy
facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
state: Liguria
city: Brescia
country: Italy
facility: Università di Brescia; Dipartimento di Dermatologia
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas; Farmacia
state: Lombardia
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
state: Marche
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
state: Piemonte
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino; Oncologia Medica
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Armando Businco; Dermatologia
state: Sardegna
city: Firenze
country: Italy
facility: Ospedale IOT- Palagi Dermatologia 2
state: Toscana
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte
state: Toscana
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
state: Veneto
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Mexico City
country: Mexico
facility: Hospital General de México
state: Mexico CITY (federal District)
city: Groningen
country: Netherlands
facility: Academ Ziekenhuis Groningen; Medical Oncology
city: Leiden
country: Netherlands
facility: LUMC; Dermatologie
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre; Dermatologie
city: Rotterdam
country: Netherlands
facility: Erasmus MC; Dermatology
city: Takapuna
country: New Zealand
facility: Waitemata District Health; General Surgery
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF; Radiumhospitalet
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Lodz
country: Poland
facility: DERMED Centrum Medyczne; Sp zoo
city: Poznan
country: Poland
facility: Centrum Diagnostyki Znamion
city: Warsaw
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Bucuresti
country: Romania
facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
city: Cluj Napoca
country: Romania
facility: Prof. Dr. I. Chiricuta Institute of Oncology
city: Craiova
country: Romania
facility: Oncology Center Sf. Nectarie
city: Targu Mures
country: Romania
facility: Spital Clinic Judetean Mures; Oncologie
city: Timisoara
country: Romania
facility: S.C. Life Search S.R.L; Medical Oncology Clinic
city: St Petersburg
country: Russian Federation
facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF
state: Leningrad
city: Moscow
country: Russian Federation
facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"
city: Moscow
country: Russian Federation
facility: Moscow city oncology hospital #62 of Moscow Healthcare Department
city: St Petersburg
country: Russian Federation
facility: Saint-Petersburg City Clinical Oncology Dispensary
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia; Medical Oncology
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocnica Roosevelta
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; Servicio de Dermatologia
state: Asturias
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases; Servicio de Oncologia
state: Islas Baleares
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia
state: LAS Palmas
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon; Servicio de Dermatologia
state: Madrid
city: Arganda del Rey
country: Spain
facility: Hospital Universitario del Sureste; Servicio de Dermatologia
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Dermatologia
state: Navarra
city: Santa Cruz de Tenerife
country: Spain
facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia
state: Tenerife
city: Bilbao
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial; Servicio de dermatología
city: Cordoba
country: Spain
facility: Hospital Reina Sofia; Servicio de dermatología
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
city: Guadalajara
country: Spain
facility: Hospital General Universitario de Guadalajara; Servicio de Dermatologia
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Murcia
country: Spain
facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia; Servicio de oncologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Dermatologia
city: Lund
country: Sweden
facility: Skånes Onkologiska Klinik, Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Solna
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich; Dermatologische Klinik
city: Ankara
country: Turkey
facility: Ankara Numune Training and Research Hospital; Dermatology
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Facultesi; Dept. of Dermatology
city: Istanbul
country: Turkey
facility: Istanbul Uni of Medicine Faculty; Oncology Dept
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medicine Faculty; Dermatology
city: Sıhhiye, Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
city: Glasgow
country: United Kingdom
facility: Western Infirmary; Division of Cardiovascular and Medical Sciences
city: London
country: United Kingdom
facility: St Thomas Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital - London
city: New Castle Upon Tyne
country: United Kingdom
facility: Freeman Hospital; Northern Centre For Cancer Care
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bossi P, Peris K, Calzavara-Pinton P, Queirolo P, Alfieri S, Palla M, Rossi MT, Spagnolo F, Tambone S, Astolfi C, Ascierto PA. Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study. Future Oncol. 2020 Jun;16(16):1091-1100. doi: 10.2217/fon-2019-0664. Epub 2020 May 6.
citation: Basset-Seguin N, Hauschild A, Kunstfeld R, Grob J, Dreno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Meyer N, Guillot B, Dummer R, Arenberger P, Fife K, Raimundo A, Dika E, Dimier N, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017 Nov;86:334-348. doi: 10.1016/j.ejca.2017.08.022. Epub 2017 Nov 5.
citation: Basset-Seguin N, Hauschild A, Grob JJ, Kunstfeld R, Dreno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Jouary T, Meyer N, Guillot B, Dummer R, Fife K, Ernst DS, Williams S, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial. Lancet Oncol. 2015 Jun;16(6):729-36. doi: 10.1016/S1470-2045(15)70198-1. Epub 2015 May 13.