A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer
Completed
Genentech, Inc.
Phase 2
2008-05-01
This was a randomized, placebo-controlled, double-blind study of vismodegib (GDC-0449) added
to biochemotherapy standard-of-care regimens for metastatic colorectal cancer (CRC), with
treatment until disease progression. Patients received either FOLFOX (FOL=leucovorin calcium
[folinic acid], F=fluorouracil, OX=oxaliplatin) or FOLFIRI (FOL=leucovorin calcium [folinic
acid] F=fluorouracil, IRI=irinotecan hydrochloride) chemotherapy with bevacizumab. The
decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and
patient. Patients were randomized to receive vismodegib or placebo and were stratified based
on the chemotherapy regimen chosen and whether or not Response Evaluation Criteria in Solid
Tumors (RECIST) measurable disease was present at baseline.
A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission
Completed
Genentech, Inc.
Phase 2
2008-12-01
The study was a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical
trial of vismodegib (GDC-0449) in patients with ovarian cancer in a second or third complete
remission. Patients were randomized in a 1:1 ratio to either vismodegib or placebo.
Randomization was stratified based on whether their cancer was in a second or third complete
remission.
GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment
Completed
National Cancer Institute (NCI)
Phase 1
2009-01-01
This phase I trial is studying the side effects and best dose of GDC-0449 in treating young
patients with medulloblastoma that is recurrent or did not respond to previous treatment.
GDC-0449 may be effective in treating young patients with medulloblastoma.
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