A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Not Recruiting

Trial ID: NCT01160250


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.

Official Title

A Single-Arm, Open-Label, Expanded Access Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Stanford Investigator(s)

Anthony Oro, MD, PhD
Anthony Oro, MD, PhD

Eugene and Gloria Bauer Professor

Anne Lynn S. Chang, MD
Anne Lynn S. Chang, MD

Professor of Dermatology

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Inclusion Criteria:

   - 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

   - 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

Exclusion Criteria:

   - Pregnancy or lactation

   - Life expectancy < 12 weeks

   - Concurrent non-protocol-specified anti-tumor therapy

   - Completion of most recent anti-tumor therapy at least 21 days prior to initiation of

   - Uncontrolled medical illnesses such as infection requiring treatment with intravenous

   - History of other disease, metabolic dysfunction, physical examination finding, or
   clinical laboratory finding giving reasonable suspicion of a disease or condition that
   contraindicates use of an investigational drug or that might affect interpretation of
   the results of the study or renders the patient at high risk from treatment

   - Unwillingness to practice effective birth control


drug: Vismodegib (GDC-0449)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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