WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS
ERIVEDGE (vismodegib) capsule can result in embryo-fetal death or severe birth defects. ERIVEDGE is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.
Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of ERIVEDGE exposure through semen [see
Warnings and Precautions, Use in Specific Populations (8.1, 8.6)
Vismodegib is an inhibitor of the hedgehog (Hh) signaling pathway.
ERIVEDGE capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
Published Studies Related to Erivedge (Vismodegib)
A phase II, randomized, placebo-controlled study of vismodegib as maintenance
therapy in patients with ovarian cancer in second or third complete remission. 
CONCLUSIONS: In this study, the sought magnitude of increase in PFS was not
A randomized phase II trial of vismodegib versus placebo with FOLFOX or FOLFIRI
and bevacizumab in patients with previously untreated metastatic colorectal
CONCLUSIONS: Vismodegib does not add to the efficacy of standard therapy for
Pharmacokinetic dose-scheduling study of hedgehog pathway inhibitor vismodegib
(GDC-0449) in patients with locally advanced or metastatic solid tumors. 
CONCLUSIONS: Vismodegib 150 mg TIW or QW failed to achieve unbound plasma
Clinical Trials Related to Erivedge (Vismodegib)
Vismodegib for Treatment of Basal Cell Carcinoma [Completed]
The primary objectives of this study are to assess, using Mohs micrographic surgery (MMS) at
the end of treatment, the efficacy (primary) and safety (secondary) of vismodegib compared
to placebo in the oral adjunctive pre surgical treatment of basal cell carcinoma. A
secondary objective is to assess how often and in what types of lesions does pre surgical
treatment with vismodegib result in complete eradication of the tumor.
Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas [Active, not recruiting]
Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma [Recruiting]
Chemotherapy, radiation therapy, and surgery are standard treatments for basal cell
carcinoma at most institutions. The purpose of this study is to determine whether adding
vismodegib to radiation (chemoradiotherapy) is safe and tolerable. The purpose of this study
is to assess the safety and tolerability of combined radiation therapy and vismodegib. This
combination may increase the chances of the tumors being destroyed or unable to spread to
other parts of the body in people with locally advanced basal cell carcinoma of the head and
Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma [Recruiting]
The purpose of this research study is to evaluate an investigational drug (Vismodegib) for
Pontine Glioma that is growing or has come back (reoccurred). This study will look at the
tumors response to the study drug, Vismodegib, and will also look at the safety and
tolerability of Vismodegib.
Vismodegib has been tested in multiple adult clinical trials and one pediatric trial.
Laboratory testing in pontine gliomas suggests that this drug may be effective in treating
A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer [Completed]
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.
Reports of Suspected Erivedge (Vismodegib) Side Effects
Muscle Spasms (4),
Cognitive Disorder (3),
Pulmonary Embolism (2),
Cardiac Failure Congestive (2),
Blood Glucose Increased (2), more >>
Page last updated: 2014-11-30