Status:
COMPLETED
A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 carcino...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2016
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT01815840
Start Date
April 30 2013
End Date
August 31 2016
Last Update
September 28 2017
Active Locations (58)
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1
Dermatology Research Associate
Los Angeles, California, United States, 90045
2
Stanford University
Palo Alto, California, United States, 94305
3
Skin Surgery Med Group, Inc
San Diego, California, United States, 92117
4
California Pacific Medical Center Research Institute
Santa Rosa, California, United States, 95403