Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01367665
Ethics application status
Date submitted
30/05/2011
Date registered
6/06/2011
Date last updated
29/08/2017

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: Single Arm -


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
Until disease progression or unacceptable toxicity (approximately 2 years)
Secondary outcome [1] 0 0
Quality of life: Skindex-16 questionnaire
Timepoint [1] 0 0
Until disease progression or unacceptable toxicity (approximately 2 years)
Secondary outcome [2] 0 0
Symptoms in metastatic BCC patients: M.D. Anderson Symptom Inventory (MDASI)
Timepoint [2] 0 0
Until disease progression or unacceptable toxicity (approximately 2 years)
Secondary outcome [3] 0 0
Tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Timepoint [3] 0 0
Until disease progression or unacceptable toxicity (approximately 2 years)
Secondary outcome [4] 0 0
Time to response
Timepoint [4] 0 0
Until disease progression or unacceptable toxicity (approximately 2 years)
Secondary outcome [5] 0 0
Duration of response
Timepoint [5] 0 0
Until disease progression or unacceptable toxicity (approximately 2 years)
Secondary outcome [6] 0 0
Progression-free survival
Timepoint [6] 0 0
Until disease progression or unacceptable toxicity (approximately 2 years)
Secondary outcome [7] 0 0
Overall survival
Timepoint [7] 0 0
Until disease progression or unacceptable toxicity (approximately 2 years)

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
Gender
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
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
Blinded (masking 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Argentina
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Buenos Aires
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Austria
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Graz
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Austria
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Salzburg
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Austria
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St. Pölten
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Austria
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Wien
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Belgium
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Leuven
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Bosnia and Herzegovina
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Banja Luka
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Bosnia and Herzegovina
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Sarajevo
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Brazil
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RS
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Brazil
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SP
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Bulgaria
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Plovdiv
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Sofia
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Alberta
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Manitoba
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Ontario
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Quebec
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Bogota
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Cali
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Medellin-Antioquia
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Medellin
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Zagreb
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Ceske Budejovice
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Czechia
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Hradec Kralove
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Ostrava
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Praha 2
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Herlev
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Helsinki
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Finland
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Kuopio
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Bordeaux
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Pierre Benite
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Buxtehude
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Erfurt
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Essen
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Frankfurt
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Freiburg
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Gera
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Heidelberg
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Heilbronn
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Kassel
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Muenster
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Nürnberg
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Regensburg
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Tübingen
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Würzburg
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Athens
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Heraklion
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Ioannina
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Haifa
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Petach Tikva
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Ramat Gan
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Lazio
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Liguria
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Marche
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Piemonte
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Puglia
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Warsaw
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Porto
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Bucuresti
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Cluj Napoca
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Cordoba
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Granada
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Guadalajara
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Leon
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Murcia
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Sevilla
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Toledo
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Valencia
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Zaragoza
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Sweden
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Lund
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Sweden
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Stockholm
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Switzerland
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Zürich
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Turkey
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Ankara
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Istanbul
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Turkey
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Izmir
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Turkey
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Sihhiye, ANKARA
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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New Castle upon Tyne
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Salford
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United Kingdom
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Sutton

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01367665
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