Vismodegib safety study in basal cell carcinoma v1
Research type
Research Study
Full title
A single arm, open-label, phase II, multicentre study, to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma (BCC)
IRAS ID
83769
Contact name
Kathryn Fife
Sponsor organisation
Roche Products Ltd
Eudract number
2011-000195-34
Clinicaltrials.gov Identifier
Research summary
Surgery can usually cure most cases of basal cell carcinoma (BCC) of the skin (also known as rodent ulcer). However in a few patients it goes on to locally advanced, or metastatic disease, which cannot be treated with surgery. At this stage there is no standard treatment and it can be debilitating or life-threatening. Defects in the Hedgehog pathway help some kinds of cancer cells to grow including BCC. Vismodegib (GDC-0449) can block these defects preventing or slowing the growth of several different types of cancer cells. In an early phase study in a variety of cancers, response of the cancer to vismodegib was seen in more than half of patients with advanced BCC (19 of 33 patients). Patients were treated daily with vismodegib for up to 19 months. The following side effects were each seen in a small number of patients and may be related to vismodegib: changes in or loss of taste; tiredness; loss of hair on the scalp, body, eyelashes, and face (alopecia); and muscle cramps. This study will be for patients with BCC for whom surgery or radiotherapy would not be suitable. It will provide more information on how well vismodegib works and its side effect profile. About 150 patients will take part over about two-years until vismodegib becomes commercially available for patients with advanced or metastatic BCC. All patients will take the same dose of vismodegib daily as a capsule. Assessments of safety and response to treatment will be recorded at monthly out-patient clinic visits. Treatment will continue until the disease gets worse, unacceptable side-effects, or the patient decides to withdraw from the study. A final, follow-up out-patient visit will take place a month after completing treatment.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
11/EE/0415
Date of REC Opinion
9 Dec 2011
REC opinion
Further Information Favourable Opinion