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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01367665




Registration number
NCT01367665
Ethics application status
Date submitted
30/05/2011
Date registered
7/06/2011
Date last updated
6/06/2019

Titles & IDs
Public title
STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Scientific 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)
Secondary ID [1] 0 0
2011-000195-34
Secondary ID [2] 0 0
MO25616
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - vismodegib

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

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


Treatment: Drugs: vismodegib
150 mg once daily until disease progression or unacceptable toxicity
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Primary outcome [2] 0 0
Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons
Timepoint [2] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Primary outcome [3] 0 0
Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters
Timepoint [3] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Primary outcome [4] 0 0
Exposure to Study Treatment: Duration on Treatment
Timepoint [4] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Primary outcome [5] 0 0
Exposure to Study Treatment - Dose Intensity
Timepoint [5] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Secondary outcome [1] 0 0
Best Overall Response Rate (BORR)
Timepoint [1] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Secondary outcome [3] 0 0
Time to Response
Timepoint [3] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Secondary outcome [4] 0 0
Progression-Free Survival (PFS)
Timepoint [4] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Secondary outcome [6] 0 0
Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom
Timepoint [6] 0 0
Baseline to the data cut-off date of 14 June 2017 (up to 6 years).
Secondary outcome [7] 0 0
Percentage of Participants With a = 30% Reduction in Disease-Related Symptoms According to MDASI Scale
Timepoint [7] 0 0
08-May-2013 (Protocol Version = 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).
Secondary outcome [8] 0 0
Percentage of Participants With a = 30% Reduction in Composite Symptom Severity Score According to MDASI Scale
Timepoint [8] 0 0
08-May-2013 (Protocol Version = 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2017
Sample size
Target
Accrual to date
Final
1232
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Premier Specialists - Kogarah
Recruitment hospital [2] 0 0
Skin and Cancer Foundation Australia - Westmead
Recruitment hospital [3] 0 0
CMAX A division of IDT Australia Limited - Adelaide
Recruitment hospital [4] 0 0
Skin & Cancer Foundation - Carlton
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Salzburg
Country [4] 0 0
Austria
State/province [4] 0 0
St. Pölten
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Bosnia and Herzegovina
State/province [7] 0 0
Banja Luka
Country [8] 0 0
Bosnia and Herzegovina
State/province [8] 0 0
Sarajevo
Country [9] 0 0
Brazil
State/province [9] 0 0
RS
Country [10] 0 0
Brazil
State/province [10] 0 0
SP
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Plovdiv
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Sofia
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Manitoba
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Colombia
State/province [17] 0 0
Bogota
Country [18] 0 0
Colombia
State/province [18] 0 0
Cali
Country [19] 0 0
Colombia
State/province [19] 0 0
Medellin-Antioquia
Country [20] 0 0
Colombia
State/province [20] 0 0
Medellin
Country [21] 0 0
Croatia
State/province [21] 0 0
Zagreb
Country [22] 0 0
Czechia
State/province [22] 0 0
Ceske Budejovice
Country [23] 0 0
Czechia
State/province [23] 0 0
Hradec Kralove
Country [24] 0 0
Czechia
State/province [24] 0 0
Ostrava
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 2
Country [26] 0 0
Czechia
State/province [26] 0 0
Praha 5
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha
Country [28] 0 0
Denmark
State/province [28] 0 0
Herlev
Country [29] 0 0
Finland
State/province [29] 0 0
Helsinki
Country [30] 0 0
Finland
State/province [30] 0 0
Kuopio
Country [31] 0 0
France
State/province [31] 0 0
Bordeaux
Country [32] 0 0
France
State/province [32] 0 0
Boulogne-billancourt
Country [33] 0 0
France
State/province [33] 0 0
Dijon
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France
State/province [34] 0 0
Lille
Country [35] 0 0
France
State/province [35] 0 0
Marseille
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France
State/province [36] 0 0
Montpellier
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France
State/province [37] 0 0
Nantes
Country [38] 0 0
France
State/province [38] 0 0
Paris
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France
State/province [39] 0 0
Pierre Benite
Country [40] 0 0
France
State/province [40] 0 0
Toulouse
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France
State/province [41] 0 0
Villejuif
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Germany
State/province [42] 0 0
Berlin
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Germany
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Buxtehude
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Germany
State/province [44] 0 0
Dortmund
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Germany
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Dresden
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Germany
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Düsseldorf
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Germany
State/province [47] 0 0
Erfurt
Country [48] 0 0
Germany
State/province [48] 0 0
Essen
Country [49] 0 0
Germany
State/province [49] 0 0
Frankfurt
Country [50] 0 0
Germany
State/province [50] 0 0
Freiburg
Country [51] 0 0
Germany
State/province [51] 0 0
Greifswald
Country [52] 0 0
Germany
State/province [52] 0 0
Hamburg
Country [53] 0 0
Germany
State/province [53] 0 0
Hannover
Country [54] 0 0
Germany
State/province [54] 0 0
Heidelberg
Country [55] 0 0
Germany
State/province [55] 0 0
Heilbronn
Country [56] 0 0
Germany
State/province [56] 0 0
Kassel
Country [57] 0 0
Germany
State/province [57] 0 0
Kiel
Country [58] 0 0
Germany
State/province [58] 0 0
Köln
Country [59] 0 0
Germany
State/province [59] 0 0
Ludwigshafen
Country [60] 0 0
Germany
State/province [60] 0 0
Lübeck
Country [61] 0 0
Germany
State/province [61] 0 0
Magdeburg
Country [62] 0 0
Germany
State/province [62] 0 0
Mannheim
Country [63] 0 0
Germany
State/province [63] 0 0
Marburg
Country [64] 0 0
Germany
State/province [64] 0 0
Muenster
Country [65] 0 0
Germany
State/province [65] 0 0
München
Country [66] 0 0
Germany
State/province [66] 0 0
Nürnberg
Country [67] 0 0
Germany
State/province [67] 0 0
Quedlinburg
Country [68] 0 0
Germany
State/province [68] 0 0
Regensburg
Country [69] 0 0
Germany
State/province [69] 0 0
Tübingen
Country [70] 0 0
Germany
State/province [70] 0 0
Würzburg
Country [71] 0 0
Greece
State/province [71] 0 0
Athens
Country [72] 0 0
Greece
State/province [72] 0 0
Heraklion
Country [73] 0 0
Greece
State/province [73] 0 0
Ioannina
Country [74] 0 0
Greece
State/province [74] 0 0
Thessaloniki
Country [75] 0 0
Hungary
State/province [75] 0 0
Budapest
Country [76] 0 0
Hungary
State/province [76] 0 0
Debrecen
Country [77] 0 0
Hungary
State/province [77] 0 0
Kaposvár
Country [78] 0 0
Hungary
State/province [78] 0 0
Szeged
Country [79] 0 0
Ireland
State/province [79] 0 0
Cork
Country [80] 0 0
Ireland
State/province [80] 0 0
Dublin
Country [81] 0 0
Israel
State/province [81] 0 0
Halfa
Country [82] 0 0
Israel
State/province [82] 0 0
Jerusalem
Country [83] 0 0
Israel
State/province [83] 0 0
Petach Tikva
Country [84] 0 0
Israel
State/province [84] 0 0
Ramat Gan
Country [85] 0 0
Italy
State/province [85] 0 0
Abruzzo
Country [86] 0 0
Italy
State/province [86] 0 0
Campania
Country [87] 0 0
Italy
State/province [87] 0 0
Emilia-Romagna
Country [88] 0 0
Italy
State/province [88] 0 0
Lazio
Country [89] 0 0
Italy
State/province [89] 0 0
Liguria
Country [90] 0 0
Italy
State/province [90] 0 0
Lombardia
Country [91] 0 0
Italy
State/province [91] 0 0
Marche
Country [92] 0 0
Italy
State/province [92] 0 0
Piemonte
Country [93] 0 0
Italy
State/province [93] 0 0
Puglia
Country [94] 0 0
Italy
State/province [94] 0 0
Sardegna
Country [95] 0 0
Italy
State/province [95] 0 0
Toscana
Country [96] 0 0
Italy
State/province [96] 0 0
Veneto
Country [97] 0 0
Lithuania
State/province [97] 0 0
Vilnius
Country [98] 0 0
Mexico
State/province [98] 0 0
Mexico CITY (federal District)
Country [99] 0 0
Netherlands
State/province [99] 0 0
Groningen
Country [100] 0 0
Netherlands
State/province [100] 0 0
Leiden
Country [101] 0 0
Netherlands
State/province [101] 0 0
Maastricht
Country [102] 0 0
Netherlands
State/province [102] 0 0
Rotterdam
Country [103] 0 0
New Zealand
State/province [103] 0 0
Takapuna
Country [104] 0 0
Norway
State/province [104] 0 0
Oslo
Country [105] 0 0
Poland
State/province [105] 0 0
Gdansk
Country [106] 0 0
Poland
State/province [106] 0 0
Lodz
Country [107] 0 0
Poland
State/province [107] 0 0
Poznan
Country [108] 0 0
Poland
State/province [108] 0 0
Warsaw
Country [109] 0 0
Portugal
State/province [109] 0 0
Porto
Country [110] 0 0
Romania
State/province [110] 0 0
Bucuresti
Country [111] 0 0
Romania
State/province [111] 0 0
Cluj Napoca
Country [112] 0 0
Romania
State/province [112] 0 0
Craiova
Country [113] 0 0
Romania
State/province [113] 0 0
Targu Mures
Country [114] 0 0
Romania
State/province [114] 0 0
Timisoara
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Leningrad
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Moscow
Country [117] 0 0
Russian Federation
State/province [117] 0 0
St Petersburg
Country [118] 0 0
Serbia
State/province [118] 0 0
Belgrade
Country [119] 0 0
Slovakia
State/province [119] 0 0
Banska Bystrica
Country [120] 0 0
Slovenia
State/province [120] 0 0
Ljubljana
Country [121] 0 0
Spain
State/province [121] 0 0
Asturias
Country [122] 0 0
Spain
State/province [122] 0 0
Islas Baleares
Country [123] 0 0
Spain
State/province [123] 0 0
LAS Palmas
Country [124] 0 0
Spain
State/province [124] 0 0
Madrid
Country [125] 0 0
Spain
State/province [125] 0 0
Navarra
Country [126] 0 0
Spain
State/province [126] 0 0
Tenerife
Country [127] 0 0
Spain
State/province [127] 0 0
Vizcaya
Country [128] 0 0
Spain
State/province [128] 0 0
Barcelona
Country [129] 0 0
Spain
State/province [129] 0 0
Cordoba
Country [130] 0 0
Spain
State/province [130] 0 0
Granada
Country [131] 0 0
Spain
State/province [131] 0 0
Guadalajara
Country [132] 0 0
Spain
State/province [132] 0 0
Leon
Country [133] 0 0
Spain
State/province [133] 0 0
Murcia
Country [134] 0 0
Spain
State/province [134] 0 0
Sevilla
Country [135] 0 0
Spain
State/province [135] 0 0
Toledo
Country [136] 0 0
Spain
State/province [136] 0 0
Valencia
Country [137] 0 0
Spain
State/province [137] 0 0
Zaragoza
Country [138] 0 0
Sweden
State/province [138] 0 0
Lund
Country [139] 0 0
Sweden
State/province [139] 0 0
Stockholm
Country [140] 0 0
Switzerland
State/province [140] 0 0
Zürich
Country [141] 0 0
Turkey
State/province [141] 0 0
Ankara
Country [142] 0 0
Turkey
State/province [142] 0 0
Istanbul
Country [143] 0 0
Turkey
State/province [143] 0 0
Izmir
Country [144] 0 0
Turkey
State/province [144] 0 0
Sihhiye, Ankara
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Cambridge
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Glasgow
Country [147] 0 0
United Kingdom
State/province [147] 0 0
London
Country [148] 0 0
United Kingdom
State/province [148] 0 0
New Castle Upon Tyne
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Salford
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01367665