A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
- Registration Number
- NCT01898598
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks. Vismodegib Vismodegib Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit Baseline, MMS visit (Week 12-14) The percent change in target BCC expected surgical defect area was defined as (\[baseline expected surgical defect area - expected surgical defect area at MMS visit\]/ baseline expected surgical defect area) × 100 percent (%) where expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.
- Secondary Outcome Measures
Name Time Method Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit Baseline, MSS Visit (Week 12-14) Actual change was defined as (baseline expected surgical defect area - expected surgical defect area at MMS visit). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment. Expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry).
Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit Baseline, MMS visit (Week 12-14) Percent change in target BCC actual tumor-free margin excision area was defined as = (expected surgical defect area pre-treatment - actual tumor-free margin excision area at MMS visit) / expected surgical defect area pre-treatment) \* 100%. The actual tumor-free margin excision area (includes 2 millimeters \[mm\] margin) was measured during MMS. The area was photographed and traced on the digital photograph then calculated by computer-aided planimetry. MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.
Percentage of Participants With Clinical Response MMS visit (Week 12-14) Clinical response was defined as a complete response (CR) or partial response (PR) at the post-treatment MMS excision. CR was defined as no histological evidence of BCC. PR was defined as a reduction of at least 50 % in the expected surgical defect area with histologic evidence of residual BCC. MMS visit was defined the visit that occurred within 2 weeks of the last study treatment.
Percentage of Participants With BCC Recurrence Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14) Percentage of Participants With Skip Area MMS visit (Week 12-14) Skip area was defined as the presence of non-contiguous residual tumor at the MMS visit, as determined by an independent dermatopathologist. MMS visit occurred within 2 weeks of the last study treatment.
Trial Locations
- Locations (21)
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Beth Israel Cancer Center; West Campus
🇺🇸New York, New York, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Moy-Fincher-Chipps Facial Plastics and Dermatology
🇺🇸Beverly Hills, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Univ of Calif-San Francisco
🇺🇸San Francisco, California, United States
University of Rochester Medical Center; University Dermatology Associates
🇺🇸Rochester, New York, United States
Laser & Skin Surgery Center of Indiana
🇺🇸Carmel, Indiana, United States
Spencer Derma & Skin Surg Ctr
🇺🇸St. Petersburg, Florida, United States
Mariwalla Dermatology
🇺🇸West Islip, New York, United States
Oregon Health & Science University; Department of Dermatology
🇺🇸Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Stanford University
🇺🇸Palo Alto, California, United States
The Skin Surgery Center
🇺🇸Winston-Salem, North Carolina, United States
Huntsman Cancer Institute at The University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States