A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]ocally advanced or metastatic basal cell carcinoma (BCC)MedDRA version: 18.1 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2011-000195-34-PT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 501
- 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 720
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 480
- 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
- Patients with one of the following rare hereditary conditions: galactose intolerance, primary hypolactasia, or glucose-galactose malabsorption
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method