Ann Arbor, Michigan 48109


Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care.


Inclusion Criteria: - Adult patients over 18 years of age with locally advanced or recurrent orbital or periorbital basal cell carcinoma (BCCA), or a medial canthal BCCA that threatens the lacrimal drainage system. - Clinical assessment score obtained at baseline. - Medical Oncology screening performed at baseline. - Adequate BCCA size and location. - Adequate hematopoietic capacity, hepatic and renal function. - Male patients must agree to use condoms during treatment and for 3 months after last dose. - Male patients must agree to not donate sperm during treatment and for 3 months after last dose. - Participant must agree not to donate blood during the study and for 7 months after last dose. - Informed consent signed. - If the patient consents to enroll, then blood will be drawn and stored for biomarker analysis. Exclusion Criteria: - Inability or unwillingness to swallow capsules. - Inability or unwillingness to comply with study procedures. - Pregnant, lactating, or breast feeding women. - Women of childbearing potential. - Uncontrolled medical illness. - Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. - Age under 18 years.



Primary Contact:

Principal Investigator
Alon Kahana, M.D., Ph.D.
University of Michigan

Alon Kahana, M.D.. Ph.D.
Phone: 734-936-8654

Backup Contact:


Location Contact:

Ann Arbor, Michigan 48109
United States

Alon Kahana, M.D., Ph.D.
Phone: 734-936-8654

Site Status: Recruiting

Data Source:

Date Processed: November 18, 2019

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