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

NCT01815840 | Completed Phase 2 Results DMC

• 2 other identifiers: MO282952012-003305-10
• Study Type: interventional
• Target: 229
• Locations: 10 countries
• Sites: 58

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)

  The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.

  Baseline; Week 73

Secondary Outcomes (11)

• Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues

  Baseline to Week 73

• Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73

  Baseline; Week 73

• Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73

  Baseline; Week 73

• Percentage of Participants With New Basal Cell Carcinomas at Week 73

  Baseline; Week 73

• Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate)

  Baseline; Week 85

Study Arms (2)

Vismodegib Intermittent Schedule

EXPERIMENTAL

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

Drug: Vismodegib; Drug: Placebo

Vismodegib Induction Followed by Intermittent Schedule

EXPERIMENTAL

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

Drug: Vismodegib; Drug: Placebo

Interventions

Vismodegib DRUG

Vismodegib 150 mg hard gelatin capsule orally once daily

Also known as: Erivedge®

Vismodegib Induction Followed by Intermittent Schedule; Vismodegib Intermittent Schedule

Placebo DRUG

Vismodegib placebo orally once daily

Vismodegib Induction Followed by Intermittent Schedule; Vismodegib Intermittent Schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (58)

Dermatology Research Associate

Los Angeles, California, 90045, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

Skin Surgery Med Group, Inc

San Diego, California, 92117, United States

Location

California Pacific Medical Center Research Institute

Santa Rosa, California, 95403, United States

Location

Advanced Derm & Cosmetic Surg

Ormond Beach, Florida, 32174, United States

Location

Skin and Cancer Associates and the Center for Cosmetic Enhancement

Plantation, Florida, 33324, United States

Location

Emory University Clinic

Atlanta, Georgia, 30322, United States

Location

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

Beverly Hospital;Oncology Center Pharmacy

Beverly, Massachusetts, 01915, United States

Location

Saint Louis University School of Medicine; Department of Dermatology

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Long Island Skin Cancer and Dermatologic Surgery

Smithtown, New York, 11787, United States

Location

Mariwalla Dermatology

West Islip, New York, 11795, United States

Location

The Skin Surgery Center

Winston-Salem, North Carolina, 27106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Dermatology and Laser Center of Charleston PA

Charleston, South Carolina, 29414, United States

Location

LKH Innsbruck; Universitätsklinik für Dermatologie

Innsbruck, 6020, Austria

Location

Medizinische Universität Wien; Univ.Klinik für Dermatologie

Vienna, 1090, Austria

Location

UBC Department of Dermatology & Skin Sciences

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Dermetics

Burlington, Ontario, L7N 3N2, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, L2K 4L5, Canada

Location

CHU Amiens - Hopital Sud

Amiens, 80054, France

Location

Hopital Saint Andre CHU De Bordeaux; Dermatologie

Bordeaux, 33075, France

Location

Chu Site Du Bocage;Dermatologie

Dijon, 21079, France

Location

Hopital Dupuytren; Dermatologie

Limoges, 87042, France

Location

Hopital Timone Adultes; Dermatologie

Marseille, 13385, France

Location

Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

Montpellier, 34295, France

Location

Hopital Hotel Dieu Et Hme; Clinique Dermatologique

Nantes, 44093, France

Location

Hôpital Saint-Louis

Paris, 75475, France

Location

Ch Francois Mitterrand; Medecine Oncologie

Pau, 64046, France

Location

Hopital Nord ; Dermatologie

Saint-Etienne, 42277, France

Location

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

Essen, 45122, Germany

Location

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

Frankfurt, 60590, Germany

Location

SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

Gera, 07548, Germany

Location

Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

Hanover, 30625, Germany

Location

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

Kiel, 24105, Germany

Location

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

München, 80337, Germany

Location

Fachklinik Hornheide; Dermatologie

Münster, 48157, Germany

Location

Universitätsklinikum Tübingen Universitäts-Hautklinik

Tübingen, 72076, Germany

Location

Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol

L’Aquila, Abruzzo, 67100, Italy

Location

Arcispedale Santa Maria Nuova; Dermatologia

Reggio Emilia, Emilia-Romagna, 42123, Italy

Location

Università di Brescia; Dipartimento di Dermatologia

Brescia, Lombardy, 25123, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Piedmont, 10126, Italy

Location

Ospedale IOT- Palagi Dermatologia 2

Florence, Tuscany, 50125, Italy

Location

Hospital General de México

Mexico City, 06726, Mexico

Location

Hospital General Dr. Manuel Gea Gonzalez; Dermatology

México, 14080, Mexico

Location

VU MEDISCH CENTRUM;Afdeling Dermatologie

Amsterdam, 1007 MB, Netherlands

Location

Academ Ziekenhuis Groningen; Medical Oncology

Groningen, 9713 GZ, Netherlands

Location

Maastricht University Medical Centre; Dermatologie

Maastricht, 6229 HX, Netherlands

Location

Blokhin Cancer Research Center; General Oncology Department

Moscow, 115478, Russia

Location

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

Moscow, 115478, Russia

Location

City Clinical Oncology Dispensary

Saint Petersburg, 197022, Russia

Location

Hospital Costa Del Sol; Servicio de Dermatologia

Málaga, Malaga, 29600, Spain

Location

Hospital Clinic i Provincial; Servicio de Farmacia

Barcelona, 08036, Spain

Location

Hospital General Universitario de Guadalajara; Servicio de Dermatologia

Guadalajara, 19002, Spain

Location

Hospital General Universitario de Valencia; Servicio de oncologia

Valencia, 41014, Spain

Location

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, 46009, Spain

Location

Related Publications (2)

• 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.

  PMID: 28325399 DERIVED

• 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.

  PMID: 28188086 DERIVED

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: April 30, 2013
• Primary Completion: August 27, 2015
• Study Completion: August 31, 2016
• Last Updated: September 28, 2017
• Results First Posted: August 4, 2016

Record last verified: 2017-08

Locations

RU (3); AU (2); IT (5); ME (2); DE (8); FR (10); US (17); NL (3); CA (3); ES (5)