NCT00959647

A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study

An Open-label, Multicenter Extension Study of GDC-0449 (Hedgehog Pathway Inhibitor) in Patients Treated With GDC-0449 in a Previous Genentech-sponsored Phase I or Phase II Cancer Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, open-label extension study. Patients who received vismodegib (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who continued to receive vismodegib at the time the parent study closed were eligible for continued treatment in this protocol.

Conditions

• Ovarian Cancer
• Basal Cell Carcinoma
• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Vismodegib	Vismodegib was supplied in capsules.
DRUG	FOLFOX	FOLFOX (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and oxaliplatin \[OX\]) was supplied as solutions for intravenous administration.
DRUG	FOLFIRI	FOLFIRI (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and irinotecan \[IRI\]) was supplied as solutions for intravenous administration.
DRUG	Bevacizumab	Bevacizumab was supplied as a solution for intravenous administration.

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2009-08-14
• Last updated: 2015-01-07
• Results posted: 2015-01-07

Locations

10 sites across 1 country: United States