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

August 30, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
229

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • LKH Innsbruck; Universitätsklinik für Dermatologie
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Univ.Klinik für Dermatologie
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • UBC Department of Dermatology & Skin Sciences
    • Ontario
      • Burlington, Ontario, Canada, L7N 3N2
        • Dermetics
    • Quebec
      • Montreal, Quebec, Canada, L2K 4L5
        • Innovaderm Research Inc.
  • France
      • Amiens, France, 80054
        • CHU Amiens - Hopital Sud
      • Bordeaux, France, 33075
        • Hopital Saint Andre CHU De Bordeaux; Dermatologie
      • Dijon, France, 21079
        • Chu Site Du Bocage;Dermatologie
      • Limoges, France, 87042
        • Hopital Dupuytren; Dermatologie
      • Marseille, France, 13385
        • Hopital Timone Adultes; Dermatologie
      • Montpellier, France, 34295
        • Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
      • Nantes, France, 44093
        • Hopital Hotel Dieu Et Hme; Clinique Dermatologique
      • Paris, France, 75475
        • Hôpital Saint-Louis
      • Pau, France, 64046
        • Ch Francois Mitterrand; Medecine Oncologie
      • Saint-Etienne, France, 42277
        • Hopital Nord ; Dermatologie
  • Germany
      • Essen, Germany, 45122
        • Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
      • Frankfurt, Germany, 60590
        • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
      • Gera, Germany, 07548
        • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
      • Kiel, Germany, 24105
        • UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
      • München, Germany, 80337
        • Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
      • Münster, Germany, 48157
        • Fachklinik Hornheide; Dermatologie
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen Universitäts-Hautklinik
  • Italy
    • Abruzzo
      • L'Aquila, Abruzzo, Italy, 67100
        • Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42123
        • Arcispedale Santa Maria Nuova; Dermatologia
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • Università di Brescia; Dipartimento di Dermatologia
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Toscana
      • Firenze, Toscana, Italy, 50125
        • Ospedale IOT- Palagi Dermatologia 2
  • Mexico
      • Mexico, Mexico, 14080
        • Hospital General Dr. Manuel Gea Gonzalez; Dermatology
      • Mexico City, Mexico, 06726
        • Hospital General de Mexico
  • Netherlands
      • Amsterdam, Netherlands, 1007 MB
        • VU MEDISCH CENTRUM;Afdeling Dermatologie
      • Groningen, Netherlands, 9713 GZ
        • Academ Ziekenhuis Groningen; Medical Oncology
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Centre; Dermatologie
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center; General Oncology Department
      • Moscow, Russian Federation, 115478
        • FSBI "Russian Oncology Research Center n.a. N. N. Blokhin" of Ministry of Health of the Russian Fed
      • Saint-Petersburg, Russian Federation, 197022
        • City Clinical Oncology Dispensary
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial; Servicio de Farmacia
      • Guadalajara, Spain, 19002
        • Hospital General Universitario de Guadalajara; Servicio de Dermatologia
      • Valencia, Spain, 46009
        • Instituto Valenciano Oncologia; Oncologia Medica
      • Valencia, Spain, 41014
        • Hospital General Universitario de Valencia; Servicio de oncologia
    • Malaga
      • Málaga, Malaga, Spain, 29600
        • Hospital Costa Del Sol; Servicio de Dermatologia
  • United States
    • California
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associate
      • Palo Alto, California, United States, 94305
        • Stanford University
      • San Diego, California, United States, 92117
        • Skin Surgery Med Group, Inc
      • Santa Rosa, California, United States, 95403
        • California Pacific Medical Center Research Institute
    • Florida
      • Ormond Beach, Florida, United States, 32174
        • Advanced Derm & Cosmetic Surg
      • Plantation, Florida, United States, 33324
        • Skin and Cancer Associates and the Center for Cosmetic Enhancement
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Clinic
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Laser & Skin Surgery Center of Indiana
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Beverly Hospital;Oncology Center Pharmacy
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University School of Medicine; Department of Dermatology
    • New York
      • Smithtown, New York, United States, 11787
        • Long Island Skin Cancer and Dermatologic Surgery
      • West Islip, New York, United States, 11795
        • Mariwalla Dermatology
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27106
        • The Skin Surgery Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Dermatology and Laser Center of Charleston PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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
Drug: Vismodegib
Vismodegib 150 mg hard gelatin capsule orally once daily
Other Names:
  • Erivedge®
Drug: Placebo
Vismodegib placebo orally once daily
EXPERIMENTAL: 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
Drug: Vismodegib
Vismodegib 150 mg hard gelatin capsule orally once daily
Other Names:
  • Erivedge®
Drug: Placebo
Vismodegib placebo orally once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)
Time Frame: Baseline; Week 73
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues
Time Frame: Baseline to Week 73
The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.
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
Time Frame: Baseline; Week 73
The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.
Baseline; Week 73
Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73
Time Frame: Baseline; Week 73
Baseline; Week 73
Percentage of Participants With New Basal Cell Carcinomas at Week 73
Time Frame: Baseline; 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)
Time Frame: Baseline; Week 85
Baseline; Week 85
Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)
Time Frame: Baseline; Week 97
Baseline; Week 97
Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)
Time Frame: Baseline; Week 125
Baseline; Week 125
Percentage of Participants Experiencing Any Adverse Event
Time Frame: Up to 125 weeks
Up to 125 weeks
Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73
Time Frame: Baseline; Week 73
The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").
Baseline; Week 73
Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73
Time Frame: Baseline; Week 73
The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their emotional state, and their answers were combined into a composite Emotion Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").
Baseline; Week 73
Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73
Time Frame: Baseline; Week 73
The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their ability to function, and answers were combined into a composite Function Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").
Baseline; Week 73

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MO28295
  • 2012-003305-10 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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