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Basal Cell CarcinomaPhase 2NCT01815840

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

A Phase 2 study testing Vismodegib in people with Basal Cell Carcinoma, run by Hoffmann-La Roche at 58 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
Vismodegib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
229 participants
Where
58 sitesin 10 countries
Study dates
30 Apr 2013to 31 Aug 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

58 sites in 10 countries.

58 sites in 10 countries

United States17 sites

  • Emory University Clinic

    Atlanta, Georgia, 30322

  • Beverly Hospital;Oncology Center Pharmacy

    Beverly, Massachusetts, 01915

  • Laser & Skin Surgery Center of Indiana

    Carmel, Indiana, 46032

  • Dermatology and Laser Center of Charleston PA

    Charleston, South Carolina, 29414

  • Ohio State University

    Columbus, Ohio, 43210

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Dermatology Research Associate

    Los Angeles, California, 90045

  • Advanced Derm & Cosmetic Surg

    Ormond Beach, Florida, 32174

  • Stanford University

    Palo Alto, California, 94305

  • Skin and Cancer Associates and the Center for Cosmetic Enhancement

    Plantation, Florida, 33324

  • Skin Surgery Med Group, Inc

    San Diego, California, 92117

  • California Pacific Medical Center Research Institute

    Santa Rosa, California, 95403

  • Long Island Skin Cancer and Dermatologic Surgery

    Smithtown, New York, 11787

  • Saint Louis University School of Medicine; Department of Dermatology

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Mariwalla Dermatology

    West Islip, New York, 11795

  • The Skin Surgery Center

    Winston-Salem, North Carolina, 27106

Other trials in United States

France10 sites

  • CHU Amiens - Hopital Sud

    Amiens, 80054

  • Hopital Saint Andre CHU De Bordeaux; Dermatologie

    Bordeaux, 33075

  • Chu Site Du Bocage;Dermatologie

    Dijon, 21079

  • Hopital Dupuytren; Dermatologie

    Limoges, 87042

  • Hopital Timone Adultes; Dermatologie

    Marseille, 13385

  • Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

    Montpellier, 34295

  • Hopital Hotel Dieu Et Hme; Clinique Dermatologique

    Nantes, 44093

  • Hôpital Saint-Louis

    Paris, 75475

  • Ch Francois Mitterrand; Medecine Oncologie

    Pau, 64046

  • Hopital Nord ; Dermatologie

    Saint-Etienne, 42277

Other trials in France

Germany8 sites

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

    Essen, 45122

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

    Frankfurt, 60590

  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

    Gera, 07548

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

    Hanover, 30625

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

    Kiel, 24105

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

    München, 80337

  • Fachklinik Hornheide; Dermatologie

    Münster, 48157

  • Universitätsklinikum Tübingen Universitäts-Hautklinik

    Tübingen, 72076

Other trials in Germany

Italy5 sites

  • Università di Brescia; Dipartimento di Dermatologia

    Brescia, Lombardy, 25123

  • Ospedale IOT- Palagi Dermatologia 2

    Florence, Tuscany, 50125

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

    L’Aquila, Abruzzo, 67100

  • Arcispedale Santa Maria Nuova; Dermatologia

    Reggio Emilia, Emilia-Romagna, 42123

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

Other trials in Italy

Spain5 sites

  • Hospital Clinic i Provincial; Servicio de Farmacia

    Barcelona, 08036

  • Hospital General Universitario de Guadalajara; Servicio de Dermatologia

    Guadalajara, 19002

  • Hospital Costa Del Sol; Servicio de Dermatologia

    Málaga, Malaga, 29600

  • Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, 41014

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

Other trials in Spain

Canada3 sites

  • Dermetics

    Burlington, Ontario, L7N 3N2

  • Innovaderm Research Inc.

    Montreal, Quebec, L2K 4L5

  • UBC Department of Dermatology & Skin Sciences

    Vancouver, British Columbia, V5Z 4E8

Other trials in Canada

Netherlands3 sites

  • VU MEDISCH CENTRUM;Afdeling Dermatologie

    Amsterdam, 1007 MB

  • Academ Ziekenhuis Groningen; Medical Oncology

    Groningen, 9713 GZ

  • Maastricht University Medical Centre; Dermatologie

    Maastricht, 6229 HX

Other trials in Netherlands

Russia3 sites

  • Blokhin Cancer Research Center; General Oncology Department

    Moscow, 115478

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

    Moscow, 115478

  • City Clinical Oncology Dispensary

    Saint Petersburg, 197022

Other trials in Russia

Austria2 sites

  • LKH Innsbruck; Universitätsklinik für Dermatologie

    Innsbruck, 6020

  • Medizinische Universität Wien; Univ.Klinik für Dermatologie

    Vienna, 1090

Other trials in Austria

Mexico2 sites

  • Hospital General Dr. Manuel Gea Gonzalez; Dermatology

    México, 14080

  • Hospital General de México

    Mexico City, 06726

Other trials in Mexico

About this study

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

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.

Being tested
Vismodegib, Placebo
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VismodegibDrug

    Also called Erivedge®

    Vismodegib 150 mg hard gelatin capsule orally once daily

  • PlaceboDrug

    Vismodegib placebo orally once daily

Study groups in NCT01815840
Study groupRoleWhat they receive
Vismodegib Intermittent ScheduleExperimentalVismodegib 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
Receives: Drug: Vismodegib; Drug: Placebo
Vismodegib Induction Followed by Intermittent ScheduleExperimentalVismodegib 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
Receives: Drug: Vismodegib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline; Week 73

Secondary outcomes (11)

  1. Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues

    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.

    Measured: Baseline to Week 73

  2. Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at 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.

    Measured: Baseline; Week 73

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

    Measured: Baseline; Week 73

  4. Percentage of Participants With New Basal Cell Carcinomas at Week 73

    Measured: Baseline; Week 73

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

    Measured: Baseline; Week 85

  6. Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)

    Measured: Baseline; Week 97

  7. Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)

    Measured: Baseline; Week 125

  8. Percentage of Participants Experiencing Any Adverse Event

    Measured: Up to 125 weeks

  9. Percent Change From Baseline in the Skindex-16 Symptom Domain Score at 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").

    Measured: Baseline; Week 73

  10. Percent Change From Baseline in the Skindex-16 Emotion Domain Score at 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").

    Measured: Baseline; Week 73

  11. Percent Change From Baseline in the Skindex-16 Function Domain Score at 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").

    Measured: Baseline; Week 73

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2013 (estimated)
  2. Study start30 Apr 2013
  3. Primary completion27 Aug 2015
  4. Study completion31 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01815840
Sponsor's protocol ID
MO28295
Other IDs
2012-003305-10
Status last verified
Aug 2017
First submitted
19 Mar 2013
Last updated
28 Sep 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28325399

  • 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.

    PubMed 28188086

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vismodegib in people with Basal Cell Carcinoma, run by Hoffmann-La Roche at 58 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, France, Germany, Italy, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01815840, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.

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