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)
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Basal Cell Carcinoma
Both
Basal Cell Carcinoma
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety: Incidence of adverse events
Outcome Time Frame:
Until disease progression or unacceptable toxicity (approximately 2 years)
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Agence Francaise de securite sanitaire des produits de sante
Study ID:
MO25616
NCT ID:
NCT01367665
Start Date:
June 2011
Completion Date:
August 2015
Related Keywords:
- Basal Cell Carcinoma
- Carcinoma
- Carcinoma, Basal Cell
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