Clinical Trials Directory

Trials / Completed

CompletedNCT00833417

A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma

A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
104 (actual)
Sponsor
Genentech, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.

Conditions

Interventions

TypeNameDescription
DRUGVismodegib 150 mgVismodegib 150 mg was provided in hard gelatin capsules.

Timeline

Start date
2009-02-01
Primary completion
2010-11-01
Completion
2014-04-01
First posted
2009-02-02
Last updated
2015-05-20
Results posted
2012-04-30

Locations

35 sites across 6 countries: United States, Australia, Belgium, France, Germany, United Kingdom

Source: ClinicalTrials.gov record NCT00833417. Inclusion in this directory is not an endorsement.