Back to resultsA Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
Primary Purpose
Basal Cell Carcinoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Vismodegib
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Mayo Clinic
- Moy-Fincher-Chipps Facial Plastics and Dermatology
- Scripps Clinic
- Loma Linda University Medical Center
- Stanford University
- California Pacific Medical Center
- Univ of Calif-San Francisco
- Spencer Derma & Skin Surg Ctr
- Northwestern University
- Laser & Skin Surgery Center of Indiana
- University of Minnesota
- Beth Israel Cancer Center; West Campus
- University of Rochester Medical Center; University Dermatology Associates
- Mariwalla Dermatology
- The Skin Surgery Center
- Oregon Health & Science University; Department of Dermatology
- Penn State Milton S. Hershey Medical Center
- Fox Chase Cancer Center
- MD Anderson Cancer Center
- Huntsman Cancer Institute at The University of Utah
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Vismodegib
Arm Description
Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
Outcomes
Primary Outcome Measures
Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
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
Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit
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
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
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 Skip Area
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.
Percentage of Participants With BCC Recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01898598
Brief Title
A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Oral Vismodegib for the Treatment of Basal Cell Carcinoma Preceding Excision by Mohs Micrographic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
January 23, 2014 (Actual)
Primary Completion Date
January 26, 2016 (Actual)
Study Completion Date
January 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
Arm Title
Vismodegib
Arm Type
Experimental
Arm Description
Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo to vismodegib for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Vismodegib
Intervention Description
Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks
Primary Outcome Measure Information:
Title
Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
Description
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.
Time Frame
Baseline, MMS visit (Week 12-14)
Secondary Outcome Measure Information:
Title
Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit
Description
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).
Time Frame
Baseline, MSS Visit (Week 12-14)
Title
Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit
Description
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.
Time Frame
Baseline, MMS visit (Week 12-14)
Title
Percentage of Participants With Clinical Response
Description
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.
Time Frame
MMS visit (Week 12-14)
Title
Percentage of Participants With Skip Area
Description
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.
Time Frame
MMS visit (Week 12-14)
Title
Percentage of Participants With BCC Recurrence
Time Frame
Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Moy-Fincher-Chipps Facial Plastics and Dermatology
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
Univ of Calif-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Spencer Derma & Skin Surg Ctr
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Laser & Skin Surgery Center of Indiana
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Beth Israel Cancer Center; West Campus
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
University of Rochester Medical Center; University Dermatology Associates
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Mariwalla Dermatology
City
West Islip
State/Province
New York
ZIP/Postal Code
11795
Country
United States
Facility Name
The Skin Surgery Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
Facility Name
Oregon Health & Science University; Department of Dermatology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-4501
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States
Facility Name
Huntsman Cancer Institute at The University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
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