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Spots Global Cancer Trial Database for A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

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Trial Identification

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

Official Title: A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas

Study ID: NCT01815840

Interventions

Vismodegib
Placebo

Study Description

Brief Summary: 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dermatology Research Associate, Los Angeles, California, United States

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, Saint Louis, Missouri, United States

Washington University School of Medicine, Saint 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, Wien, , 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

Hopital Dupuytren; Dermatologie, Limoges, , France

Hopital Timone Adultes; Dermatologie, Marseille, , France

Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie, Montpellier, , France

Hopital Hotel Dieu Et Hme; Clinique Dermatologique, Nantes, , France

Hôpital Saint-Louis, Paris, , France

Ch Francois Mitterrand; Medecine Oncologie, Pau, , France

Hopital Nord ; Dermatologie, Saint-Etienne, , France

Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Essen, , Germany

Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie, Frankfurt, , Germany

SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie, Gera, , Germany

Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie, Hannover, , Germany

UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie, Kiel, , Germany

Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie, München, , Germany

Fachklinik Hornheide; Dermatologie, Münster, , Germany

Universitätsklinikum Tübingen Universitäts-Hautklinik, Tübingen, , Germany

Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol, L'Aquila, Abruzzo, Italy

Arcispedale Santa Maria Nuova; Dermatologia, Reggio Emilia, Emilia-Romagna, Italy

Università di Brescia; Dipartimento di Dermatologia, Brescia, Lombardia, Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, Piemonte, Italy

Ospedale IOT- Palagi Dermatologia 2, Firenze, Toscana, Italy

Hospital General de México, Mexico City, , Mexico

Hospital General Dr. Manuel Gea Gonzalez; Dermatology, Mexico, , Mexico

VU MEDISCH CENTRUM;Afdeling Dermatologie, Amsterdam, , Netherlands

Academ Ziekenhuis Groningen; Medical Oncology, Groningen, , Netherlands

Maastricht University Medical Centre; Dermatologie, Maastricht, , Netherlands

Blokhin Cancer Research Center; General Oncology Department, Moscow, , Russian Federation

FSBI "Russian Oncology Research Center n.a. N. N. Blokhin" of Ministry of Health of the Russian Fed, Moscow, , Russian Federation

City Clinical Oncology Dispensary, Saint-Petersburg, , Russian Federation

Hospital Costa Del Sol; Servicio de Dermatologia, Málaga, Malaga, Spain

Hospital Clinic i Provincial; Servicio de Farmacia, Barcelona, , Spain

Hospital General Universitario de Guadalajara; Servicio de Dermatologia, Guadalajara, , Spain

Hospital General Universitario de Valencia; Servicio de oncologia, Valencia, , Spain

Instituto Valenciano Oncologia; Oncologia Medica, Valencia, , Spain

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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