A Single-Arm, Open-Label, Expanded Access Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
This is an open-label, non-comparative, multicenter, expanded access study of Vismodegib (GDC-0449) in patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC (mBCC) who are otherwise without satisfactory treatment options.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Vismodegib (GDC-0449)
Phase: Phase 4
Ages Eligible For Study:
- For patients with mBCC, histologic confirmation of distant BCC metastasis - For patients with locally advanced BCC, at least one histologically confirmed lesion 10 mm or more in diameter and written confirmation from a surgical specialist that the tumor is considered inoperable or that surgery is contraindicated - For patients with locally advanced BCC, radiotherapy must have been previously administered for locally advanced BCC, unless radiotherapy is contraindicated or inappropriate. For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation. - Patients with Gorlin syndrome may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above - Patients with measurable and/or non-measurable disease (as defined by RECIST) are allowed - Adequate organ function - For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of Vismodegib (GDC-0449) - For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of Vismodegib (GDC-0449)