A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Completed · Phase 2 · Has a placebo group

Conditions studied: Basal Cell Carcinoma

In brief

This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.

Key facts

Study ID

NCT01815840

Run by

Hoffmann-La Roche

People needed

229

Starts

2013-04-30

Expected to finish

2016-08-31

Last updated by the study team

2017-09-28

Who can join

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

You may qualify if…

• Adult participants, >/= 18 years of age
• Participants with multiple basal cell carcinomas, including participants with Gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. All other lesions are considered to be non-target lesions
• Histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Adequate renal and hepatic function and hematopoietic capacity
• Women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 9 months after completion of study treatment
• Male participants with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment

You may not qualify if…

• Inability or unwillingness to swallow capsules
• Pregnant or breastfeeding women
• Any metastatic basal cell carcinoma
• Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery
• Recent (i.e., within the past 28 days prior to randomization) or current participation in another experimental drug study
• Known or suspected alcohol abuse
• One of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption

Where it is running

• Stanford University — Palo Alto, California, United States
• Skin Surgery Med Group, Inc — San Diego, California, United States
• California Pacific Medical Center Research Institute — Santa Rosa, California, United States
• Advanced Derm & Cosmetic Surg — Ormond Beach, Florida, United States
• Skin and Cancer Associates and the Center for Cosmetic Enhancement — Plantation, Florida, United States
• Emory University Clinic — Atlanta, Georgia, United States
• Laser & Skin Surgery Center of Indiana — Carmel, Indiana, United States
• Beverly Hospital;Oncology Center Pharmacy — Beverly, Massachusetts, United States
• Saint Louis University School of Medicine; Department of Dermatology — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Long Island Skin Cancer and Dermatologic Surgery — Smithtown, New York, United States
• Mariwalla Dermatology — West Islip, New York, United States
• The Skin Surgery Center — Winston-Salem, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Dermatology and Laser Center of Charleston PA — Charleston, South Carolina, United States
• LKH Innsbruck; Universitätsklinik für Dermatologie — Innsbruck, Austria
• Medizinische Universität Wien; Univ.Klinik für Dermatologie — Vienna, Austria
• UBC Department of Dermatology & Skin Sciences — Vancouver, British Columbia, Canada
• Dermetics — Burlington, Ontario, Canada
• Innovaderm Research Inc. — Montreal, Quebec, Canada
• CHU Amiens - Hopital Sud — Amiens, France
• Hopital Saint Andre CHU De Bordeaux; Dermatologie — Bordeaux, France
• Chu Site Du Bocage;Dermatologie — Dijon, France
• Dermatology Research Associate — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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