Locally advanced or metastatic basal cell carcinoma (BCC) MedDRA version: 14.1 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: vismodegib
Product Code: GDC-0449
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: vismodegib
CAS Number: 879085-55-9
Current Sponsor code: GDC-0449
Concentration unit: mg milli
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 480 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 320
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic BCC;Primary end point(s): The primary objective of this trial is to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic BCC.;Timepoint(s) of evaluation of this end point: Until disease progression or unacceptable toxicity (approximately 2 years);Secondary Objective: - To assess the overall response rate (according to RECIST Version 1.1) in those patients with measurable disease as permitted by local regulatory requirement. - To assess other efficacy parameters such as time to response, duration of response, progression-free survival and overall survival. - To assess patient quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) - Time to response - Duration of response - Progression-free survival - Overall survival;Timepoint(s) of evaluation of this end point: Until disease progression or unacceptable toxicity (approximately 2 years) | — |
Countries
Albania, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd.
Outcome results
None listed