A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas
NCT ID: NCT01815840
Last Updated: 2017-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
229 participants
INTERVENTIONAL
2013-04-30
2016-08-31
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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Vismodegib Intermittent Schedule
Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib
Vismodegib 150 mg hard gelatin capsule orally once daily
Placebo
Vismodegib placebo orally once daily
Vismodegib Induction Followed by Intermittent Schedule
Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Vismodegib
Vismodegib 150 mg hard gelatin capsule orally once daily
Placebo
Vismodegib placebo orally once daily
Interventions
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Vismodegib
Vismodegib 150 mg hard gelatin capsule orally once daily
Placebo
Vismodegib placebo orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
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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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
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
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
Hanover, , 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, Lombardy, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Ospedale IOT- Palagi Dermatologia 2
Florence, Tuscany, Italy
Hospital General de México
Mexico City, , Mexico
Hospital General Dr. Manuel Gea Gonzalez; Dermatology
México, , 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, , Russia
FSBI "Russian Oncology Research Center n.a. N. N. Blokhin" of Ministry of Health of the Russian Fed
Moscow, , Russia
City Clinical Oncology Dispensary
Saint Petersburg, , Russia
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
Countries
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References
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Jacobsen AA, Kydd AR, Strasswimmer J. Practical management of the adverse effects of Hedgehog pathway inhibitor therapy for basal cell carcinoma. J Am Acad Dermatol. 2017 Apr;76(4):767-768. doi: 10.1016/j.jaad.2016.04.063. No abstract available.
Dreno B, Kunstfeld R, Hauschild A, Fosko S, Zloty D, Labeille B, Grob JJ, Puig S, Gilberg F, Bergstrom D, Page DR, Rogers G, Schadendorf D. Two intermittent vismodegib dosing regimens in patients with multiple basal-cell carcinomas (MIKIE): a randomised, regimen-controlled, double-blind, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):404-412. doi: 10.1016/S1470-2045(17)30072-4. Epub 2017 Feb 8.
Other Identifiers
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2012-003305-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO28295
Identifier Type: -
Identifier Source: org_study_id