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

Primary Purpose

Basal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
vismodegib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia
  • Premier Specialists
  • Skin and Cancer Foundation Australia
  • CMAX A division of IDT Australia Limited
  • Skin & Cancer Foundation
  • LKH Graz; Abteilung für allgemeine Dermatologie
  • LKH Salzburg; Universitätsklinik für Dermatologie
  • Landesklinikum St. Pölten
  • Medizinische Universität Wien; Univ.Klinik für Dermatologie
  • UZ Leuven Gasthuisberg
  • University Clinical Center of the Republic of Srpska
  • Clinic of Oncology, University Clinical Center Sarajevo
  • Hospital das Clinicas - UFRGS
  • Hospital de Cancer de Barretos
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • District Oncology Dispensary; Department for Oncology and Dermatology
  • National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic
  • Western Canada Dermatology Institute
  • Cancer Care Manitoba
  • London Regional Cancer Centre
  • Dr. Nowell Solish Cosmetic Dermatology
  • Victoria Park MediSpa
  • Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)
  • Inst. Nacional de Cancerologia; Clinica de Seno
  • Riesgo De Fractura; Rheumatology
  • Hemato Oncologos S.A.
  • Hospital Pablo Tobon Uribe
  • Reumalab Sas; Rheumatology
  • Clinical Hospital Sisters of Mercy
  • Nemocnice Ceske Budejovice
  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
  • Fakultní nemocnice Ostrava; Kožní oddělení
  • Vseobecna fakultni nemocnice v Praze
  • Fakultni nemocnice v Motole
  • Fakultni nemocnice Kralovske Vinohrady
  • Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni
  • Herlev Hospital; Onkologisk afdeling
  • Helsinki University Central Hospital; Skin & Allergy Hospital
  • Kuopion yliopistollinen sairaala
  • Hopital Saint Andre CHU De Bordeaux; Dermatologie
  • Hopital Ambroise Pare; Sce Dermatologie
  • Chu Site Du Bocage;Dermatologie
  • Hopital Claude Huriez; Sce Dermatologie
  • Hopital Timone Adultes; Dermatologie
  • Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
  • Hopital Hotel Dieu Et Hme; Clinique Dermatologique
  • Hopital Saint Louis; Dermatologie 1
  • Centre Hospitalier Lyon Sud; Dermatologie
  • Hôpital Larrey Université Paul Sabatier; Service Dermatologie
  • Institut Gustave Roussy; Comite 5
  • Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle
  • Vivantes Klinikum Spandau
  • Elbekliniken Buxtehude; Klinik für Dermatologie
  • Klinikum Dortmund gGmbH Klinikzentrum Mitte
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie
  • Universitätsklinikum Düsseldorf; Hautklinik
  • HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie
  • Universitätsklinikum Essen
  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
  • Universitätsklinikum Freiburg Universitäts-Hautklinik
  • Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen
  • Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie
  • Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
  • Universitätsklinikum Heidelberg
  • Klinikum am Gesundbrunnen; Tumorzentrum
  • Klinikum Kassel; Hautklinik
  • UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
  • Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie
  • Klinikum d.Stadt Ludwigshafen Hautklinik
  • Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)
  • Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie
  • Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie
  • Universitätsklinikum Marburg Klinik f. Dermatologie
  • Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie
  • Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
  • Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie
  • Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
  • Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie
  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie
  • Universitaets-Hautklinik Tuebingen
  • Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
  • Laiko General Hospital; 1St Pathological Clinic
  • Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department
  • Univ General Hosp Heraklion; Medical Oncology
  • University General Hospital of loannina; Dermatology and Venereal Diseases Clinic
  • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika
  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika
  • Kaposi Mor Teaching Hospital
  • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
  • Cork University Hospital; Dermatology Dept
  • St Vincent'S Uni Hospital; Medical Oncology
  • Rambam Medical Center
  • Hadassah University Hospital - Ein Kerem
  • Rabin Medical Center-Beilinson Campus
  • Sheba Medical Center; Tel Hashomer
  • Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • Policlinico Sant'Orsola Malpighi; U.O. Dermatologia
  • I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico
  • Azienda Ospedaliera Umberto I; Clinica Dermatologica
  • Fondazione Ptv Policlinico Tor Vergata; Dermatologia
  • Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica
  • Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica
  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • Università di Brescia; Dipartimento di Dermatologia
  • Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo
  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
  • IRCCS Istituto Clinico Humanitas; Farmacia
  • A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
  • Ospedale Antonio Perrino; Oncologia Medica
  • Ospedale Armando Businco; Dermatologia
  • Ospedale IOT- Palagi Dermatologia 2
  • A.O.U. Senese Policlinico Santa Maria Alle Scotte
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
  • National Cancer Institute
  • Hospital General de México
  • Academ Ziekenhuis Groningen; Medical Oncology
  • LUMC; Dermatologie
  • Maastricht University Medical Centre; Dermatologie
  • Erasmus MC; Dermatology
  • Waitemata District Health; General Surgery
  • Oslo Universitetssykehus HF; Radiumhospitalet
  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • DERMED Centrum Medyczne; Sp zoo
  • Centrum Diagnostyki Znamion
  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna
  • IPO do Porto; Servico de Oncologia Medica
  • Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
  • Prof. Dr. I. Chiricuta Institute of Oncology
  • Oncology Center Sf. Nectarie
  • Spital Clinic Judetean Mures; Oncologie
  • S.C. Life Search S.R.L; Medical Oncology Clinic
  • FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF
  • FSBI "National Medical Research Center of Oncology N.N. Blokhin"
  • Moscow city oncology hospital #62 of Moscow Healthcare Department
  • Saint-Petersburg City Clinical Oncology Dispensary
  • Institute for Oncology and Radiology of Serbia; Medical Oncology
  • Military Medical Academy
  • Fakultna Nemocnica Roosevelta
  • Institute of Oncology Ljubljana
  • Hospital Univ. Central de Asturias; Servicio de Dermatologia
  • Hospital Universitario Son Espases; Servicio de Oncologia
  • Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia
  • Fundacion Hospital de Alcorcon; Servicio de Dermatologia
  • Hospital Universitario del Sureste; Servicio de Dermatologia
  • Clinica Universitaria de Navarra; Servicio de Dermatologia
  • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia
  • Hospital de Cruces; Servicio de Oncologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia
  • Hospital Clinic i Provincial; Servicio de dermatología
  • Hospital Reina Sofia; Servicio de dermatología
  • Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
  • Hospital General Universitario de Guadalajara; Servicio de Dermatologia
  • Complejo Asistencial Universitario de Leon; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia
  • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia
  • Hospital General Universitario de Valencia; Servicio de oncologia
  • Instituto Valenciano Oncologia; Oncologia Medica
  • Hospital Universitario Miguel Servet; Servicio Dermatologia
  • Skånes Onkologiska Klinik, Universitetssjukhuset
  • Karolinska Universitetssjukhuset, Solna
  • Universitätsspital Zürich; Dermatologische Klinik
  • Ankara Numune Training and Research Hospital; Dermatology
  • Gazi Universitesi Tip Facultesi; Dept. of Dermatology
  • Istanbul Uni of Medicine Faculty; Oncology Dept
  • Dokuz Eylul University Medicine Faculty; Dermatology
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
  • Western Infirmary; Division of Cardiovascular and Medical Sciences
  • St Thomas Hospital
  • Royal Marsden Hospital - London
  • Freeman Hospital; Northern Centre For Cancer Care
  • Salford Royal NHS Foundation Trust
  • The Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vismodegib - Locally Advanced

Vismodegib - Metastatic

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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)."
Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters
Exposure to Study Treatment: Duration on Treatment
Duration on treatment was the number of days between first and last dose of study treatment.
Exposure to Study Treatment - Dose Intensity
Dose intensity was defined as the percentage of actual number of doses received versus planned.

Secondary Outcome Measures

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.
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.
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).
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.
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.
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).
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.
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.

Full Information

First Posted
May 30, 2011
Last Updated
March 4, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01367665
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2011 (Actual)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vismodegib - Locally Advanced
Arm Type
Experimental
Arm Description
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
Arm Title
Vismodegib - Metastatic
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
vismodegib
Intervention Description
150 mg once daily until disease progression or unacceptable toxicity
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Title
Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons
Description
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)."
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Title
Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Title
Exposure to Study Treatment: Duration on Treatment
Description
Duration on treatment was the number of days between first and last dose of study treatment.
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Title
Exposure to Study Treatment - Dose Intensity
Description
Dose intensity was defined as the percentage of actual number of doses received versus planned.
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Secondary Outcome Measure Information:
Title
Best Overall Response Rate (BORR)
Description
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.
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Title
Duration of Response
Description
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.
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Title
Time to Response
Description
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).
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.
Time Frame
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Title
Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom
Description
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).
Time Frame
Baseline to the data cut-off date of 14 June 2017 (up to 6 years).
Title
Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale
Description
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.
Time Frame
08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).
Title
Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale
Description
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.
Time Frame
08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
32374193
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.
Results Reference
derived
PubMed Identifier
29073584
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.
Results Reference
derived
PubMed Identifier
25981813
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.
Results Reference
derived

Learn more about this trial

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

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