STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

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)

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.

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Drug: vismodegib

• Study Type: Interventional
• Enrollment (Actual): 1232
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1417
    • Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialists
    • Westmead, New South Wales, Australia, 2145
      • Skin and Cancer Foundation Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX A division of IDT Australia Limited
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin & Cancer Foundation
• Austria
  • Graz, Austria, 8036
    • LKH Graz; Abteilung für allgemeine Dermatologie
  • Salzburg, Austria, 5020
    • LKH Salzburg; Universitätsklinik für Dermatologie
  • St. Pölten, Austria, 3100
    • Landesklinikum St. Pölten
  • Wien, Austria, 1090
    • Medizinische Universität Wien; Univ.Klinik für Dermatologie
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University clinical center of the Republic of Srpska
  • Sarajevo, Bosnia and Herzegovina, 7100
    • Clinic of Oncology, University Clinical Center Sarajevo
• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
      • Hospital das Clinicas - UFRGS
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Hospital de Cancer de Barretos
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • District Oncology Dispensary; Department for Oncology and Dermatology
  • Sofia, Bulgaria, 1756
    • National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic
• Canada
  • Quebec, Canada, G1V 4X7
    • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
  • Alberta
    • Edmonton, Alberta, Canada, T5J 3S9
      • Western Canada Dermatology Institute
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Cancer Care Manitoba
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Centre
    • Toronto, Ontario, Canada, M5R 3N8
      • Dr. Nowell Solish Cosmetic Dermatology
  • Quebec
    • Montreal, Quebec, Canada, H3Z 1C3
      • Victoria Park Medispa
• Colombia
  • Bogota, Colombia
    • Riesgo De Fractura; Rheumatology
  • Bogota, Colombia
    • Inst. Nacional de Cancerologia; Clinica de Seno
  • Cali, Colombia
    • Hemato Oncologos S.A.
  • Medellin, Colombia
    • Reumalab Sas; Rheumatology
  • Medellin-Antioquia, Colombia
    • Hospital Pablo Tobón Uribe
• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hospital Sisters of Mercy
• Czechia
  • Ceske Budejovice, Czechia, 370 87
    • Nemocnice Ceske Budejovice
  • Hradec Kralove, Czechia, 500 05
    • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
  • Ostrava, Czechia, 708 52
    • Fakultní nemocnice Ostrava; Kožní oddělení
  • Praha, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha, Czechia, 140 59
    • Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital; Onkologisk afdeling
• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Central Hospital; Skin & Allergy Hospital
  • Kuopio, Finland, 70211
    • Kuopion yliopistollinen sairaala
• France
  • Bordeaux, France, 33075
    • Hopital Saint Andre CHU De Bordeaux; Dermatologie
  • Boulogne-billancourt, France, 92100
    • Hopital Ambroise Pare; Sce Dermatologie
  • Dijon, France, 21079
    • Chu Site Du Bocage;Dermatologie
  • Lille, France, 59037
    • Hopital Claude Huriez; Sce Dermatologie
  • Marseille, France, 13385
    • Hopital Timone Adultes; Dermatologie
  • Montpellier, France, 34295
    • Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
  • Nantes, France, 44093
    • Hopital Hotel Dieu Et Hme; Clinique Dermatologique
  • Paris, France, 75475
    • Hopital Saint Louis; Dermatologie 1
  • Pierre Benite, France, 69495
    • Centre Hospitalier Lyon Sud; Dermatologie
  • Toulouse, France, 31000
    • Hôpital Larrey Université Paul Sabatier; Service Dermatologie
  • Villejuif, France, 94805
    • Institut Gustave Roussy; Comite 5
• Germany
  • Berlin, Germany, 13585
    • Vivantes Klinikum Spandau
  • Berlin, Germany, 10117
    • Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle
  • Buxtehude, Germany, 21614
    • Elbekliniken Buxtehude; Klinik für Dermatologie
  • Dortmund, Germany, 44137
    • Klinikum Dortmund gGmbH Klinikzentrum Mitte
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf; Hautklinik
  • Erfurt, Germany, 99089
    • HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie
  • Essen, Germany, 45122
    • Universitätsklinikum Essen
  • Frankfurt, Germany, 60590
    • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
  • Freiburg, Germany, 79104
    • Universitätsklinikum Freiburg Universitäts-Hautklinik
  • Greifswald, Germany, 17489
    • Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Heilbronn, Germany, 74078
    • Klinikum am Gesundbrunnen; Tumorzentrum
  • Kassel, Germany, 34125
    • Klinikum Kassel; Hautklinik
  • Kiel, Germany, 24105
    • UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
  • Köln, Germany, 50937
    • Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie
  • Ludwigshafen, Germany, 67063
    • Klinikum d.Stadt Ludwigshafen Hautklinik
  • Lübeck, Germany, 23562
    • Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie
  • Mannheim, Germany, 68167
    • Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
  • Marburg, Germany, 35043
    • Universitätsklinikum Marburg Klinik f. Dermatologie
  • Muenster, Germany, 48149
    • Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie
  • München, Germany, 80337
    • Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
  • München, Germany, 80802
    • Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie
  • Nürnberg, Germany, 90419
    • Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
  • Quedlinburg, Germany, 06484
    • Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
  • Tübingen, Germany, 72076
    • Universitaets-Hautklinik Tuebingen
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
• Greece
  • Athens, Greece, 115 27
    • Laiko General Hospital; 1St Pathological Clinic
  • Athens, Greece, 16121
    • Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion; Medical Oncology
  • Ioannina, Greece, 455 00
    • University General Hospital of loannina; Dermatology and Venereal Diseases Clinic
  • Thessaloniki, Greece, 546 45
    • Euromedical General Clinic of Thessaloniki; Oncology Department
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika
  • Debrecen, Hungary, 4012
    • Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika
  • Kaposvár, Hungary, 7400
    • Kaposi Mor Teaching Hospital
  • Szeged, Hungary, 6720
    • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
• Ireland
  • Cork, Ireland
    • Cork University Hospital; Dermatology Dept
  • Dublin, Ireland, 4
    • St Vincent'S Uni Hospital; Medical Oncology
• Israel
  • Halfa, Israel, 31096
    • Rambam Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah University Hospital - Ein Kerem
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center-Beilinson Campus
  • Ramat Gan, Israel, 5262100
    • Sheba Medical Center; Tel Hashomer
• Italy
  • Abruzzo
    • L'Aquila, Abruzzo, Italy, 67100
      • Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori Fondazione G. Pascale
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Policlinico Sant'Orsola Malpighi; U.O. Dermatologia
    • Meldola, Emilia-Romagna, Italy, 47014
      • I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico
  • Lazio
    • Roma, Lazio, Italy, 00100
      • Azienda Ospedaliera Umberto I; Clinica Dermatologica
    • Roma, Lazio, Italy, 00133
      • Fondazione Ptv Policlinico Tor Vergata; Dermatologia
    • Roma, Lazio, Italy, 00144
      • Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica
    • Roma, Lazio, Italy, 00167
      • Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • Università di Brescia; Dipartimento di Dermatologia
    • Milano, Lombardia, Italy, 20162
      • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
    • Milano, Lombardia, Italy, 20141
      • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
    • Milano, Lombardia, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo
    • Rozzano, Lombardia, Italy, 20089
      • IRCCS Istituto Clinico Humanitas; Farmacia
  • Marche
    • Ancona, Marche, Italy, 60121
      • A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
  • Piemonte
    • Candiolo, Piemonte, Italy, 10060
      • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • Puglia
    • Brindisi, Puglia, Italy, 72100
      • Ospedale Antonio Perrino; Oncologia Medica
  • Sardegna
    • Cagliari, Sardegna, Italy, 09121
      • Ospedale Armando Businco; Dermatologia
  • Toscana
    • Firenze, Toscana, Italy, 50125
      • Ospedale IOT- Palagi Dermatologia 2
    • Siena, Toscana, Italy, 53100
      • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Veneto
    • Padova, Veneto, Italy, 35128
      • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
• Lithuania
  • Vilnius, Lithuania, 08660
    • National Cancer Institute
• Mexico
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 06726
      • Hospital General de Mexico
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Academ Ziekenhuis Groningen; Medical Oncology
  • Leiden, Netherlands, 2333 ZA
    • LUMC; Dermatologie
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Centre; Dermatologie
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC; Dermatology
• New Zealand
  • Takapuna, New Zealand, 0620
    • Waitemata District Health; General Surgery
• Norway
  • Oslo, Norway, 0310
    • Oslo Universitetssykehus HF; Radiumhospitalet
• Poland
  • Gdańsk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • Lodz, Poland, 90-265
    • DERMED Centrum Medyczne; Sp zoo
  • Poznan, Poland, 61-821
    • Centrum Diagnostyki Znamion
  • Warsaw, Poland, 00-973
    • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna
• Portugal
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Romania
  • Bucuresti, Romania, 022328
    • Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
  • Cluj Napoca, Romania, 400015
    • Prof. Dr. I. Chiricuta Institute of Oncology
  • Craiova, Romania, 200347
    • Oncology Center Sf. Nectarie
  • Targu Mures, Romania, 540142
    • Spital Clinic Judetean Mures; Oncologie
  • Timisoara, Romania, 300167
    • S.C. Life Search S.R.L; Medical Oncology Clinic
• Russian Federation
  • Moscow, Russian Federation, 115478
    • FSBI "National Medical Research Center of Oncology N.N. Blokhin"
  • Moscow, Russian Federation, 143423
    • Moscow city oncology hospital #62 of Moscow Healthcare Department
  • St Petersburg, Russian Federation, 197022
    • Saint-Petersburg City Clinical Oncology Dispensary
  • Leningrad
    • St Petersburg, Leningrad, Russian Federation, 197758
      • FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF
• Serbia
  • Belgrade, Serbia, 11040
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Institute for Oncology and Radiology of Serbia; Medical Oncology
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna Nemocnica Roosevelta
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana
• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial; Servicio de dermatología
  • Cordoba, Spain, 14004
    • Hospital Reina Sofia; Servicio de dermatología
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
  • Guadalajara, Spain, 19002
    • Hospital General Universitario de Guadalajara; Servicio de Dermatologia
  • Leon, Spain, 24071
    • Complejo Asistencial Universitario de Leon; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Murcia, Spain, 30008
    • Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Toledo, Spain, 45004
    • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia
  • Valencia, Spain, 46009
    • Instituto Valenciano Oncologia; Oncologia Medica
  • Valencia, Spain, 41014
    • Hospital General Universitario de Valencia; Servicio de oncologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio Dermatologia
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Hospital Univ. Central de Asturias; Servicio de Dermatologia
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Hospital Universitario Son Espases; Servicio de Oncologia
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35020
      • Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Fundacion Hospital de Alcorcon; Servicio de Dermatologia
    • Arganda del Rey, Madrid, Spain, 28500
      • Hospital Universitario del Sureste; Servicio de Dermatologia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Dermatologia
  • Tenerife
    • Santa Cruz de Tenerife, Tenerife, Spain, 38010
      • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48903
      • Hospital de Cruces; Servicio de Oncologia
• Sweden
  • Lund, Sweden, 22185
    • Skånes Onkologiska Klinik, Universitetssjukhuset
  • Stockholm, Sweden, 113 41
    • Karolinska Universitetssjukhuset, Solna
• Switzerland
  • Zürich, Switzerland, 8091
    • Universitätsspital Zürich; Dermatologische Klinik
• Turkey
  • Ankara, Turkey, 06100
    • Ankara Numune Training and Research Hospital; Dermatology
  • Ankara, Turkey, 06500
    • Gazi Universitesi Tip Facultesi; Dept. of Dermatology
  • Istanbul, Turkey, 34390
    • Istanbul Uni of Medicine Faculty; Oncology Dept
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Medicine Faculty; Dermatology
  • Sıhhiye, Ankara, Turkey, 06100
    • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
  • Glasgow, United Kingdom, G11 6NT
    • Western Infirmary; Division of Cardiovascular and Medical Sciences
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital - London
  • London, United Kingdom, SE1 7EH
    • St Thomas Hospital
  • New Castle Upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital; Northern Centre For Cancer Care
  • Salford, United Kingdom, M6 8HD
    • Salford Royal NHS Foundation Trust
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vismodegib - Locally Advanced; Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity	Drug: vismodegib; 150 mg once daily until disease progression or unacceptable toxicity
Experimental: Vismodegib - Metastatic; Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity	Drug: vismodegib; 150 mg once daily until disease progression or unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons	Reasons for "other" included "unknown," "natural causes," "cardiac decompensation," "general state alteration," "deterioration of general state," "clinical deterioration taking into consideration patient's age," "old age," and "disease progression of mediastinal squamous cell carcinoma (SCC)."	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters		Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Exposure to Study Treatment: Duration on Treatment	Duration on treatment was the number of days between first and last dose of study treatment.	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Exposure to Study Treatment - Dose Intensity	Dose intensity was defined as the percentage of actual number of doses received versus planned.	Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Overall Response Rate (BORR)	BORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) required a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Duration of Response	Duration of response was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of disease progression or death for any cause. Median duration of response was estimated using Kaplan-Meier estimates.	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Time to Response	Time to response was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occur first).	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Progression-Free Survival (PFS)	PFS was defined as the time interval between the date of the first therapy and the date of progression or death for any causes, whichever occurs first. Disease progression was assessed by the investigator.	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Overall Survival (OS)	OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.	Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom	The Skindex-16 questionnaire includes three domains for the assessment of the effects of skin disease on participants' quality of life: symptoms, emotions and function. For each domain, responses from the questionnaire were transformed to a linear scale of 100 varying from 0 (never bothered, i.e., best) to 100 (always bothers, i.e., worst).	Baseline to the data cut-off date of 14 June 2017 (up to 6 years).
Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale	M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when "at their worst" in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours.	08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).
Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale	M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when "at their worst" in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours.	08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): June 14, 2017
• Study Completion (Actual): June 14, 2017

Study Registration Dates

• First Submitted: May 30, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: MO25616; 2011-000195-34 (EudraCT Number)