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

NCT01367665 | Completed Phase 2 Results

• 2 other identifiers: MO256162011-000195-34
• Study Type: interventional
• Target: 1,232
• Locations: 34 countries
• Sites: 174

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Best Overall Response Rate (BORR)

  Baseline to the data cut-off of 14 June 2017 (up to 6 years)

• Duration of Response

  Baseline to the data cut-off of 14 June 2017 (up to 6 years)

• Time to Response

  Baseline to the data cut-off of 14 June 2017 (up to 6 years)

• Progression-Free Survival (PFS)

  Baseline to the data cut-off of 14 June 2017 (up to 6 years)

• Overall Survival (OS)

  Baseline to the data cut-off of 14 June 2017 (up to 6 years)

Study Arms (2)

Vismodegib - Locally Advanced

EXPERIMENTAL

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

Vismodegib - Metastatic

EXPERIMENTAL

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

Interventions

vismodegib DRUG

150 mg once daily until disease progression or unacceptable toxicity

Vismodegib - Locally Advanced; Vismodegib - Metastatic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (181)

Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia

Buenos Aires, 1417, Argentina

Location

Premier Specialists

Kogarah, New South Wales, 2217, Australia

Location

Skin and Cancer Foundation Australia

Westmead, New South Wales, 2145, Australia

Location

CMAX A division of IDT Australia Limited

Adelaide, South Australia, 5000, Australia

Location

Skin & Cancer Foundation

Carlton, Victoria, 3053, Australia

Location

LKH Graz; Abteilung für allgemeine Dermatologie

Graz, 8036, Austria

Location

LKH Salzburg; Universitätsklinik für Dermatologie

Salzburg, 5020, Austria

Location

Landesklinikum St. Pölten

Sankt Pölten, 3100, Austria

Location

Medizinische Universität Wien; Univ.Klinik für Dermatologie

Vienna, 1090, Austria

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

University Clinical Center of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, 7100, Bosnia and Herzegovina

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

District Oncology Dispensary; Department for Oncology and Dermatology

Plovdiv, 4000, Bulgaria

Location

National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic

Sofia, 1756, Bulgaria

Location

Western Canada Dermatology Institute

Edmonton, Alberta, T5J 3S9, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Dr. Nowell Solish Cosmetic Dermatology

Toronto, Ontario, M5R 3N8, Canada

Location

Victoria Park MediSpa

Montreal, Quebec, H3Z 1C3, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)

Québec, G1V 4X7, Canada

Location

Inst. Nacional de Cancerologia; Clinica de Seno

Bogotá, Colombia

Location

Riesgo De Fractura; Rheumatology

Bogotá, Colombia

Location

Hemato Oncologos S.A.

Cali, Colombia

Location

Hospital Pablo Tobon Uribe

Medellin-Antioquia, Colombia

Location

Reumalab Sas; Rheumatology

Medellín, Colombia

Location

Clinical Hospital Sisters of Mercy

Zagreb, 10000, Croatia

Location

Nemocnice Ceske Budejovice

České Budějovice, 370 87, Czechia

Location

Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

Hradec Králové, 500 05, Czechia

Location

Fakultní nemocnice Ostrava; Kožní oddělení

Ostrava, 708 52, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

Prague, 140 59, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Herlev Hospital; Onkologisk afdeling

Herlev, 2730, Denmark

Location

Helsinki University Central Hospital; Skin & Allergy Hospital

Helsinki, 00029, Finland

Location

Kuopion yliopistollinen sairaala

Kuopio, 70211, Finland

Location

Hopital Saint Andre CHU De Bordeaux; Dermatologie

Bordeaux, 33075, France

Location

Hopital Ambroise Pare; Sce Dermatologie

Boulogne-Billancourt, 92100, France

Location

Chu Site Du Bocage;Dermatologie

Dijon, 21079, France

Location

Hopital Claude Huriez; Sce Dermatologie

Lille, 59037, France

Location

Hopital Timone Adultes; Dermatologie

Marseille, 13385, France

Location

Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

Montpellier, 34295, France

Location

Hopital Hotel Dieu Et Hme; Clinique Dermatologique

Nantes, 44093, France

Location

Hopital Saint Louis; Dermatologie 1

Paris, 75475, France

Location

Centre Hospitalier Lyon Sud; Dermatologie

Pierre-Bénite, 69495, France

Location

Hôpital Larrey Université Paul Sabatier; Service Dermatologie

Toulouse, 31000, France

Location

Institut Gustave Roussy; Comite 5

Villejuif, 94805, France

Location

Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle

Berlin, 10117, Germany

Location

Vivantes Klinikum Spandau

Berlin, 13585, Germany

Location

Elbekliniken Buxtehude; Klinik für Dermatologie

Buxtehude, 21614, Germany

Location

Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie

Cologne, 50937, Germany

Location

Klinikum Dortmund gGmbH Klinikzentrum Mitte

Dortmund, 44137, Germany

Location

Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf; Hautklinik

Düsseldorf, 40225, Germany

Location

HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

Erfurt, 99089, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt, 60590, Germany

Location

Universitätsklinikum Freiburg Universitäts-Hautklinik

Freiburg im Breisgau, 79104, Germany

Location

Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen

Greifswald, 17489, Germany

Location

Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Klinikum am Gesundbrunnen; Tumorzentrum

Heilbronn, 74078, Germany

Location

Klinikum Kassel; Hautklinik

Kassel, 34125, Germany

Location

UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

Kiel, 24105, Germany

Location

Klinikum d.Stadt Ludwigshafen Hautklinik

Ludwigshafen, 67063, Germany

Location

Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)

Lübeck, 23562, Germany

Location

Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie

Magdeburg, 39120, Germany

Location

Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

Mannheim, 68167, Germany

Location

Universitätsklinikum Marburg Klinik f. Dermatologie

Marburg, 35043, Germany

Location

Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

München, 80337, Germany

Location

Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie

München, 80802, Germany

Location

Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie

Münster, 48149, Germany

Location

Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie

Nuremberg, 90419, Germany

Location

Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie

Quedlinburg, 06484, Germany

Location

Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

Regensburg, 93053, Germany

Location

Universitaets-Hautklinik Tuebingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie

Würzburg, 97080, Germany

Location

Laiko General Hospital; 1St Pathological Clinic

Athens, 115 27, Greece

Location

Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department

Athens, 16121, Greece

Location

Univ General Hosp Heraklion; Medical Oncology

Heraklion, 711 10, Greece

Location

University General Hospital of loannina; Dermatology and Venereal Diseases Clinic

Ioannina, 455 00, Greece

Location

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, 546 45, Greece

Location

Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika

Budapest, 1085, Hungary

Location

Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

Budapest, 1122, Hungary

Location

Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

Debrecen, 4012, Hungary

Location

Kaposi Mor Teaching Hospital

Kaposvár, 7400, Hungary

Location

Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

Szeged, 6720, Hungary

Location

Cork University Hospital; Dermatology Dept

Cork, Ireland

Location

St Vincent'S Uni Hospital; Medical Oncology

Dublin, 4, Ireland

Location

Rambam Medical Center

Halfa, 31096, Israel

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001, Israel

Location

Rabin Medical Center-Beilinson Campus

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center; Tel Hashomer

Ramat Gan, 5262100, Israel

Location

Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol

L’Aquila, Abruzzo, 67100, Italy

Location

Ospedale Antonio Perrino; Oncologia Medica

Brindisi, Apulia, 72100, Italy

Location

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, Campania, 80131, Italy

Location

Policlinico Sant'Orsola Malpighi; U.O. Dermatologia

Bologna, Emilia-Romagna, 40138, Italy

Location

I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico

Meldola, Emilia-Romagna, 47014, Italy

Location

Azienda Ospedaliera Umberto I; Clinica Dermatologica

Rome, Lazio, 00100, Italy

Location

Fondazione Ptv Policlinico Tor Vergata; Dermatologia

Rome, Lazio, 00133, Italy

Location

Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica

Rome, Lazio, 00144, Italy

Location

Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica

Rome, Lazio, 00167, Italy

Location

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

Genoa, Liguria, 16132, Italy

Location

Università di Brescia; Dipartimento di Dermatologia

Brescia, Lombardy, 25123, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

Milan, Lombardy, 20133, Italy

Location

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

Milan, Lombardy, 20141, Italy

Location

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milan, Lombardy, 20162, Italy

Location

IRCCS Istituto Clinico Humanitas; Farmacia

Rozzano, Lombardy, 20089, Italy

Location

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

Candiolo, Piedmont, 10060, Italy

Location

Ospedale Armando Businco; Dermatologia

Cagliari, Sardinia, 09121, Italy

Location

A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

Ancona, The Marches, 60121, Italy

Location

Ospedale IOT- Palagi Dermatologia 2

Florence, Tuscany, 50125, Italy

Location

A.O.U. Senese Policlinico Santa Maria Alle Scotte

Siena, Tuscany, 53100, Italy

Location

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

Padua, Veneto, 35128, Italy

Location

National Cancer Institute

Vilnius, 08660, Lithuania

Location

Hospital General de México

Mexico City, Mexico CITY (federal District), 06726, Mexico

Location

Academ Ziekenhuis Groningen; Medical Oncology

Groningen, 9713 GZ, Netherlands

Location

LUMC; Dermatologie

Leiden, 2333 ZA, Netherlands

Location

Maastricht University Medical Centre; Dermatologie

Maastricht, 6229 HX, Netherlands

Location

Erasmus MC; Dermatology

Rotterdam, 3015 GD, Netherlands

Location

Waitemata District Health; General Surgery

Takapuna, 0620, New Zealand

Location

Oslo Universitetssykehus HF; Radiumhospitalet

Oslo, 0310, Norway

Location

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, 80-952, Poland

Location

DERMED Centrum Medyczne; Sp zoo

Lodz, 90-265, Poland

Location

Centrum Diagnostyki Znamion

Poznan, 61-821, Poland

Location

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna

Warsaw, 00-973, Poland

Location

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Location

Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

Bucharest, 022328, Romania

Location

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, 400015, Romania

Location

Oncology Center Sf. Nectarie

Craiova, 200347, Romania

Location

Spital Clinic Judetean Mures; Oncologie

Târgu Mureş, 540142, Romania

Location

S.C. Life Search S.R.L; Medical Oncology Clinic

Timișoara, 300167, Romania

Location

FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

FSBI "National Medical Research Center of Oncology N.N. Blokhin"

Moscow, 115478, Russia

Location

Moscow city oncology hospital #62 of Moscow Healthcare Department

Moscow, 143423, Russia

Location

Saint-Petersburg City Clinical Oncology Dispensary

Saint Petersburg, 197022, Russia

Location

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11040, Serbia

Location

Fakultna Nemocnica Roosevelta

Banská Bystrica, 975 17, Slovakia

Location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

Hospital Universitario Son Espases; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia

Las Palmas de Gran Canaria, LAS Palmas, 35020, Spain

Location

Fundacion Hospital de Alcorcon; Servicio de Dermatologia

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitario del Sureste; Servicio de Dermatologia

Arganda, Madrid, 28500, Spain

Location

Clinica Universitaria de Navarra; Servicio de Dermatologia

Pamplona, Navarre, 31008, Spain

Location

Hospital Univ. Central de Asturias; Servicio de Dermatologia

Oviedo, Principality of Asturias, 33006, Spain

Location

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital de Cruces; Servicio de Oncologia

Bilbao, Vizcaya, 48903, Spain

Location

Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia

Barcelona, 08025, Spain

Location

Hospital Clinic i Provincial; Servicio de dermatología

Barcelona, 08036, Spain

Location

Hospital Reina Sofia; Servicio de dermatología

Córdoba, 14004, Spain

Location

Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

Granada, 18014, Spain

Location

Hospital General Universitario de Guadalajara; Servicio de Dermatologia

Guadalajara, 19002, Spain

Location

Complejo Asistencial Universitario de Leon; Servicio de Oncologia

León, 24071, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Location

Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia

Murcia, 30008, Spain

Location

Hospital Universitario Virgen Macarena; Servicio de Oncologia

Seville, 41009, Spain

Location

Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia

Toledo, 45004, Spain

Location

Hospital General Universitario de Valencia; Servicio de oncologia

Valencia, 41014, Spain

Location

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, 46009, Spain

Location

Hospital Universitario Miguel Servet; Servicio Dermatologia

Zaragoza, 50009, Spain

Location

Skånes Onkologiska Klinik, Universitetssjukhuset

Lund, 22185, Sweden

Location

Karolinska Universitetssjukhuset, Solna

Stockholm, 113 41, Sweden

Location

Universitätsspital Zürich; Dermatologische Klinik

Zurich, 8091, Switzerland

Location

Ankara Numune Training and Research Hospital; Dermatology

Ankara, 06100, Turkey (Türkiye)

Location

Gazi Universitesi Tip Facultesi; Dept. of Dermatology

Ankara, 06500, Turkey (Türkiye)

Location

Istanbul Uni of Medicine Faculty; Oncology Dept

Istanbul, 34390, Turkey (Türkiye)

Location

Dokuz Eylul University Medicine Faculty; Dermatology

Izmir, 35340, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sıhhiye, Ankara, 06100, Turkey (Türkiye)

Location

Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279

Cambridge, CB2 0QQ, United Kingdom

Location

Western Infirmary; Division of Cardiovascular and Medical Sciences

Glasgow, G11 6NT, United Kingdom

Location

St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

Royal Marsden Hospital - London

London, SW3 6JJ, United Kingdom

Location

Freeman Hospital; Northern Centre For Cancer Care

New Castle Upon Tyne, NE7 7DN, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

The Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 32374193 DERIVED

• 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.

  PMID: 29073584 DERIVED

• 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.

  PMID: 25981813 DERIVED

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 7, 2011
• Study Start: July 1, 2011
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-03

Locations

SE (2); BO (2); BR (3); IE (2); NZ (1); NO (1); PL (4); BE (1); AU (4); DE (31); LI (1); IL (4); SL (1); AR (1); PT (1); RO (5); IT (21); CR (1); NL (4); RU (4); ME (1); HU (5); CO (5); DK (1); ES (22); CH (1); FI (2); TU (5); CA (6); CZ (7); GR (5); FR (11); GB (7); BU (2)