Status:
TERMINATED
A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.
Eligibility Criteria
Inclusion
- Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
- Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
- Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements
Exclusion
- Prior treatment with vismodegib
- Known hypersensitivity to any of the study drug excipients
- Any metastatic basal cell carcinoma
- Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
- Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
- Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
- Recent, current, or planned participation in another experimental drug study
Key Trial Info
Start Date :
January 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01898598
Start Date
January 23 2014
End Date
January 26 2016
Last Update
May 8 2017
Active Locations (21)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Moy-Fincher-Chipps Facial Plastics and Dermatology
Beverly Hills, California, United States, 90210
3
Scripps Clinic
La Jolla, California, United States, 92037
4
Loma Linda University Medical Center
Loma Linda, California, United States, 92354