Clinical Trial Protocol Registry

Trial information

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

Status:
Recruiting
Protocol number:
MO25616
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official 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)
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. Target sample size is 1200.
Study phase:
II
Study type:
Interventional; Treatment; Non-randomized; Open label; Single group; Safety/efficacy study
Conditions:
  • Basal Cell Carcinoma
Primary outcome:
  1. Safety: Incidence of adverse events Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Key secondary outcomes:
  1. Tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
  2. Time to response Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
  3. Duration of response Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
  4. Progression-free survival Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
  5. Overall survival Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
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
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
June, 2011
Trial registration date:
22.02.2011
Date last updated:
10.06.2013
This trial is being conducted at the following locations:
Albania
  • TIRANA
Argentina
  • BUENOS AIRES
AUSTRALIA
  • Kogarah, New S
  • Westmead, New S
  • Adelaide, South
  • Carlton, Victo
AUSTRIA
  • GRAZ
  • Salzburg
  • St. Pölten
  • Wien
Belgium
  • LEUVEN
BOSNIA AND HERZEGOVINA
  • Banja Luka
  • SARAJEVO
Brazil
  • PORTO ALEGRE
BRAZIL
  • Rio de Janeiro, RJ
  • Barretos, SP
  • Sao Paulo, SP
BULGARIA
  • PLOVDIV
  • Sofia
Canada
  • LONDON, ON
CANADA
  • Edmonton, Alber
  • Winnipeg, Manit
  • Toronto, Ontar
  • Montreal, Quebe
  • Quebec, Quebe
Colombia
  • BOGOTA
COLOMBIA
  • BOGOTA
  • Cali
  • Medellin
  • Medellin-Antioquia
CROATIA
  • Zagreb
Czech Republic
  • HRADEC KRALOVE
CZECH REPUBLIC
  • OLOMOUC
  • OSTRAVA
  • Praha
  • PRAHA
  • PRAHA 2
  • Praha 5
Denmark
  • HILLEROD
Estonia
  • TALLIN
FINLAND
  • HELSINKI
  • Kuopio
France
  • BORDEAUX
  • LILLE
  • VILLEJUIF
FRANCE
  • BOULOGNE-BILLANCOURT
  • Dijon
  • Marseille
  • MONTPELLIER
  • Nantes
  • Paris
  • Pierre Benite
  • Toulouse
Germany
  • ESSEN
  • FRANKFURT
  • KIEL
  • KOELN
  • MANNHEIM
  • MUENSTER
GERMANY
  • Berlin
  • BUXTEHUDE
  • Dortmund
  • Dresden
  • Düsseldorf
  • Erfurt
  • Freiburg
  • Gera
  • Greifswald
  • Hamburg
  • Hannover
  • Heidelberg
  • Heilbronn
  • Kassel
  • Lübeck
  • Ludwigshafen
  • Magdeburg
  • Marburg
  • Muenchen
  • München
  • Nürnberg
  • Quedlinburg
  • Regensburg
  • TÜBINGEN
  • Würzburg
Greece
  • ATHENS
GREECE
  • Athens
  • Heraklion
  • Ioannina
  • Thessaloniki
HUNGARY
  • Budapest
  • Debrecen
  • Kaposvár
  • Pecs
  • Szeged
Ireland
  • DUBLIN
IRELAND
  • CORK
Israel
  • BEER SHEVA
  • RAMAT GAN
ISRAEL
  • Haifa
  • Jerusalem
  • PETACH TIKVA
Italy
  • ANCONA
  • CANDIOLO
  • GENOVA
  • MILANO
ITALY
  • Bologna
  • Brescia
  • Brindisi
  • Cagliari
  • Firenze
  • L’Aquila
  • Meldola
  • MILANO
  • Napoli
  • PADOVA
  • Roma
  • ROMA
  • Rozzano
  • SIENA
LITHUANIA
  • Vilnius
Mexico
  • MEXICO CITY
MEXICO
  • Mexico
  • MEXICO CITY
Netherlands
  • GRONINGEN
NETHERLANDS
  • Leiden
  • Maastricht
  • Rotterdam
NEW ZEALAND
  • Takapuna
NORWAY
  • Oslo
PERU
  • Chiclayo
  • Piura
POLAND
  • Gdansk
  • Lodz
  • Poznan
  • Warsaw
Portugal
  • PORTO
Romania
  • CLUJ-NAPOCA
ROMANIA
  • Bucuresti
  • Craiova
  • Targu Mures
  • Timisoara
Russian Federation
  • MOSCOW
  • ST PETERSBURG
RUSSIAN FEDERATION
  • Moscow
SERBIA
  • Belgrade
Slovenia
  • LJUBLJANA
South Africa
  • PORT ELIZABETH
  • PRETORIA
SOUTH AFRICA
  • Bloemfontein
  • Cape Town
  • Johannesburg
  • Pretoria
Spain
  • BARAKALDO
  • GRANADA
  • MADRID
  • SEVILLA
  • VALENCIA
SPAIN
  • Oviedo, ASTUR
  • Barcelona, BARCE
  • Cordoba, CORDO
  • Guadalajara, GUADA
  • Palma De Mallorca, ISLAS
  • LAS PALMAS DE GRAN CANARIA, LAS P
  • LEON, LEON
  • Alcorcon, MADRI
  • Arganda del Rey, MADRI
  • Madrid, MADRI
  • Murcia, MURCI
  • Pamplona, NAVAR
  • Santa Cruz de Tenerife, TENER
  • Toledo, TOLED
  • Zaragoza, ZARAG
SWEDEN
  • LUND
  • Stockholm
Switzerland
  • ZÜRICH
Turkey
  • ANKARA
  • ISTANBUL
TURKEY
  • Ankara
  • Izmir
UKRAINE
  • Kyiv
United Kingdom
  • GLASGOW
UNITED KINGDOM
  • Cambridge
  • London
  • New Castle upon Tyne
  • Salford
  • Sutton

Link to trial result

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