A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
NCT ID: NCT01898598
Last Updated: 2017-05-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
18 participants
INTERVENTIONAL
2014-01-23
2016-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
Placebo
Participants will receive matching placebo to vismodegib for 12 weeks.
Vismodegib
Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
Vismodegib
Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks
Interventions
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Placebo
Participants will receive matching placebo to vismodegib for 12 weeks.
Vismodegib
Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
Moy-Fincher-Chipps Facial Plastics and Dermatology
Beverly Hills, California, United States
Scripps Clinic
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Stanford University
Palo Alto, California, United States
California Pacific Medical Center
San Francisco, California, United States
Univ of Calif-San Francisco
San Francisco, California, United States
Spencer Derma & Skin Surg Ctr
St. Petersburg, Florida, United States
Northwestern University
Chicago, Illinois, United States
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Beth Israel Cancer Center; West Campus
New York, New York, United States
University of Rochester Medical Center; University Dermatology Associates
Rochester, New York, United States
Mariwalla Dermatology
West Islip, New York, United States
The Skin Surgery Center
Winston-Salem, North Carolina, 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
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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ML28726
Identifier Type: -
Identifier Source: org_study_id
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