A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Basal Cell Carcinoma

In brief

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.

Key facts

Study ID

NCT01898598

Run by

Hoffmann-La Roche

People needed

18

Starts

2014-01-23

Expected to finish

2016-01-26

Last updated by the study team

2017-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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