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

Basal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815840
• Other study ID #: MO28295
• Secondary ID: 2012-003305-10
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2013
• Last updated: August 30, 2017
• Start date: April 30, 2013
• Est. completion date: August 31, 2016

Study information

• Verified date: August 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: August 31, 2016
• Est. primary completion date: August 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Basal Cell Nevus Syndrome
• Carcinoma
• Carcinoma, Basal Cell
• Hamartoma Syndrome, Multiple

Intervention

Drug:
• Vismodegib
Vismodegib 150 mg hard gelatin capsule orally once daily
• Placebo
Vismodegib placebo orally once daily

Locations

Country	Name	City	State
Austria	LKH Innsbruck; Universitätsklinik für Dermatologie	Innsbruck
Austria	Medizinische Universität Wien; Univ.Klinik für Dermatologie	Wien
Canada	Dermetics	Burlington	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	UBC Department of Dermatology & Skin Sciences	Vancouver	British Columbia
France	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
Germany	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	Hannover
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
Italy	Università di Brescia; Dipartimento di Dermatologia	Brescia	Lombardia
Italy	Ospedale IOT- Palagi Dermatologia 2	Firenze	Toscana
Italy	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	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino	Piemonte
Mexico	Hospital General Dr. Manuel Gea Gonzalez; Dermatology	Mexico
Mexico	Hospital General de México	Mexico City
Netherlands	VU MEDISCH CENTRUM;Afdeling Dermatologie	Amsterdam
Netherlands	Academ Ziekenhuis Groningen; Medical Oncology	Groningen
Netherlands	Maastricht University Medical Centre; Dermatologie	Maastricht
Russian Federation	Blokhin Cancer Research Center; General Oncology Department	Moscow
Russian Federation	FSBI "Russian Oncology Research Center n.a. N. N. Blokhin" of Ministry of Health of the Russian Fed	Moscow
Russian Federation	City Clinical Oncology Dispensary	Saint-Petersburg
Spain	Hospital Clinic i Provincial; Servicio de Farmacia	Barcelona
Spain	Hospital General Universitario de Guadalajara; Servicio de Dermatologia	Guadalajara
Spain	Hospital Costa Del Sol; Servicio de Dermatologia	Málaga	Malaga
Spain	Hospital General Universitario de Valencia; Servicio de oncologia	Valencia
Spain	Instituto Valenciano Oncologia; Oncologia Medica	Valencia
United States	Emory University Clinic	Atlanta	Georgia
United States	Beverly Hospital;Oncology Center Pharmacy	Beverly	Massachusetts
United States	Laser & Skin Surgery Center of Indiana	Carmel	Indiana
United States	Dermatology and Laser Center of Charleston PA	Charleston	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Dermatology Research Associate	Los Angeles	California
United States	Advanced Derm & Cosmetic Surg	Ormond Beach	Florida
United States	Stanford University	Palo Alto	California
United States	Skin and Cancer Associates and the Center for Cosmetic Enhancement	Plantation	Florida
United States	Saint Louis University School of Medicine; Department of Dermatology	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Skin Surgery Med Group, Inc	San Diego	California
United States	California Pacific Medical Center Research Institute	Santa Rosa	California
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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Italy,  Mexico,  Netherlands,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to Week 73
Secondary	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.	Baseline; Week 73
Secondary	Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73		Baseline; Week 73
Secondary	Percentage of Participants With New Basal Cell Carcinomas at Week 73		Baseline; Week 73
Secondary	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
Secondary	Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)		Baseline; Week 97
Secondary	Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)		Baseline; Week 125
Secondary	Percentage of Participants Experiencing Any Adverse Event		Up to 125 weeks
Secondary	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").	Baseline; Week 73
Secondary	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").	Baseline; Week 73
Secondary	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").	Baseline; Week 73