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

Primary Purpose

Basal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vismodegib
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dermatology Research Associate
  • Stanford University
  • Skin Surgery Med Group, Inc
  • California Pacific Medical Center Research Institute
  • Advanced Derm & Cosmetic Surg
  • Skin and Cancer Associates and the Center for Cosmetic Enhancement
  • Emory University Clinic
  • Laser & Skin Surgery Center of Indiana
  • Beverly Hospital;Oncology Center Pharmacy
  • Saint Louis University School of Medicine; Department of Dermatology
  • Washington University School of Medicine
  • Long Island Skin Cancer and Dermatologic Surgery
  • Mariwalla Dermatology
  • The Skin Surgery Center
  • Ohio State University
  • Penn State Milton S. Hershey Medical Center
  • Dermatology and Laser Center of Charleston PA
  • LKH Innsbruck; Universitätsklinik für Dermatologie
  • Medizinische Universität Wien; Univ.Klinik für Dermatologie
  • UBC Department of Dermatology & Skin Sciences
  • Dermetics
  • Innovaderm Research Inc.
  • CHU Amiens - Hopital Sud
  • Hopital Saint Andre CHU De Bordeaux; Dermatologie
  • Chu Site Du Bocage;Dermatologie
  • Hopital Dupuytren; Dermatologie
  • Hopital Timone Adultes; Dermatologie
  • Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
  • Hopital Hotel Dieu Et Hme; Clinique Dermatologique
  • Hôpital Saint-Louis
  • Ch Francois Mitterrand; Medecine Oncologie
  • Hopital Nord ; Dermatologie
  • Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
  • SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
  • Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
  • UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
  • Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
  • Fachklinik Hornheide; Dermatologie
  • Universitätsklinikum Tübingen Universitäts-Hautklinik
  • Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol
  • Arcispedale Santa Maria Nuova; Dermatologia
  • Università di Brescia; Dipartimento di Dermatologia
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Ospedale IOT- Palagi Dermatologia 2
  • Hospital General de México
  • Hospital General Dr. Manuel Gea Gonzalez; Dermatology
  • VU MEDISCH CENTRUM;Afdeling Dermatologie
  • Academ Ziekenhuis Groningen; Medical Oncology
  • Maastricht University Medical Centre; Dermatologie
  • Blokhin Cancer Research Center; General Oncology Department
  • FSBI "Russian Oncology Research Center n.a. N. N. Blokhin" of Ministry of Health of the Russian Fed
  • City Clinical Oncology Dispensary
  • Hospital Costa Del Sol; Servicio de Dermatologia
  • Hospital Clinic i Provincial; Servicio de Farmacia
  • Hospital General Universitario de Guadalajara; Servicio de Dermatologia
  • Hospital General Universitario de Valencia; Servicio de oncologia
  • Instituto Valenciano Oncologia; Oncologia Medica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vismodegib Intermittent Schedule

Vismodegib Induction Followed by Intermittent Schedule

Arm Description

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 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73
Percentage of Participants With New Basal Cell Carcinomas at 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)
Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)
Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)
Percentage of Participants Experiencing Any Adverse Event
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").
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").
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").

Full Information

First Posted
March 19, 2013
Last Updated
August 30, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01815840
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 30, 2013 (Actual)
Primary Completion Date
August 27, 2015 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vismodegib Intermittent Schedule
Arm Type
Experimental
Arm Description
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
Arm Title
Vismodegib Induction Followed by Intermittent Schedule
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Vismodegib
Other Intervention Name(s)
Erivedge®
Intervention Description
Vismodegib 150 mg hard gelatin capsule orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vismodegib placebo orally once daily
Primary Outcome Measure Information:
Title
Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)
Description
The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.
Time Frame
Baseline; Week 73
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues
Description
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.
Time Frame
Baseline to Week 73
Title
Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73
Description
The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.
Time Frame
Baseline; Week 73
Title
Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73
Time Frame
Baseline; Week 73
Title
Percentage of Participants With New Basal Cell Carcinomas at Week 73
Time Frame
Baseline; Week 73
Title
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
Title
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
Title
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
Title
Percentage of Participants Experiencing Any Adverse Event
Time Frame
Up to 125 weeks
Title
Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73
Description
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").
Time Frame
Baseline; Week 73
Title
Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73
Description
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").
Time Frame
Baseline; Week 73
Title
Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73
Description
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").
Time Frame
Baseline; Week 73

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Research Associate
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Skin Surgery Med Group, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
California Pacific Medical Center Research Institute
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Advanced Derm & Cosmetic Surg
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Skin and Cancer Associates and the Center for Cosmetic Enhancement
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Emory University Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Laser & Skin Surgery Center of Indiana
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Beverly Hospital;Oncology Center Pharmacy
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Saint Louis University School of Medicine; Department of Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Long Island Skin Cancer and Dermatologic Surgery
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Mariwalla Dermatology
City
West Islip
State/Province
New York
ZIP/Postal Code
11795
Country
United States
Facility Name
The Skin Surgery Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Dermatology and Laser Center of Charleston PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
LKH Innsbruck; Universitätsklinik für Dermatologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Dermatologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
UBC Department of Dermatology & Skin Sciences
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Dermetics
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3N2
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
L2K 4L5
Country
Canada
Facility Name
CHU Amiens - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Saint Andre CHU De Bordeaux; Dermatologie
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Chu Site Du Bocage;Dermatologie
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Dupuytren; Dermatologie
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Timone Adultes; Dermatologie
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Ch Francois Mitterrand; Medecine Oncologie
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
Hopital Nord ; Dermatologie
City
Saint-Etienne
ZIP/Postal Code
42277
Country
France
Facility Name
Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Fachklinik Hornheide; Dermatologie
City
Münster
ZIP/Postal Code
48157
Country
Germany
Facility Name
Universitätsklinikum Tübingen Universitäts-Hautklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol
City
L'Aquila
State/Province
Abruzzo
ZIP/Postal Code
67100
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova; Dermatologia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42123
Country
Italy
Facility Name
Università di Brescia; Dipartimento di Dermatologia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale IOT- Palagi Dermatologia 2
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50125
Country
Italy
Facility Name
Hospital General de México
City
Mexico City
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Hospital General Dr. Manuel Gea Gonzalez; Dermatology
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
VU MEDISCH CENTRUM;Afdeling Dermatologie
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
Academ Ziekenhuis Groningen; Medical Oncology
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastricht University Medical Centre; Dermatologie
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Blokhin Cancer Research Center; General Oncology Department
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
FSBI "Russian Oncology Research Center n.a. N. N. Blokhin" of Ministry of Health of the Russian Fed
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
City Clinical Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Hospital Costa Del Sol; Servicio de Dermatologia
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29600
Country
Spain
Facility Name
Hospital Clinic i Provincial; Servicio de Farmacia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario de Guadalajara; Servicio de Dermatologia
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Hospital General Universitario de Valencia; Servicio de oncologia
City
Valencia
ZIP/Postal Code
41014
Country
Spain
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28325399
Citation
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.
Results Reference
derived
PubMed Identifier
28188086
Citation
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.
Results Reference
derived

Learn more about this trial

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

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