A Phase II, Multicenter, Single-Arm, Two-Cohort Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Patients With Advanced Basal Cell Carcinoma
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response (OR) Determined by the Independent Review Facility
OR=complete (CR) or partial response (PR). Metastatic-CR:Disappearance of all targets. PR:≥30% decreased sum of longest diameter (SLD) of targets compared to baseline (B). Locally advanced-Response=No progressive disease (PD) and ≥30% decreased SLD from baseline (radiography [R]) or ≥30% decreased SLD from B (externally visible dimension [EVD]) or completely resolved ulceration. CR:Response with no residual BCC on tumor biopsy (otherwise response was PR). PD:Any of ≥20% increased SLD from nadir (R or EVD), new ulceration, new lesions (R or physical exam) or non-target lesion progression by R.
From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks
No
Jeannie Hou, M.D.
Study Director
Genentech
United States: Food and Drug Administration
SHH4476g
NCT00833417
February 2009
February 2014
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Bettendorf, Iowa 52722 | |
Alexandria, Minnesota 56308 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Lebanon, New Hampshire | |
Las Vegas, Nevada 89109 |