The purpose of this study is to compare how well tolerated and effective four different dosing schedules (two personalized, intermittent dosing schedules as compared to a fixed intermittent and continuous dosing regimen) work in people with advanced basal cell carcinoma.
Patients with a cytologically or histologically confirmed locally advanced basal cell carcinoma. (Nodal involvement permitted)
Adult males or females 18 years of age or older at time of signing informed consent. All races and ethnicities are eligible, and no upper limit of age is specified.
Must have ability to comprehend and the willingness to sign written informed consent for study participation.
Patients must have at least one cutaneous tumor site amenable to direct and accurate measurement by ruler/calipers.
Received prior hedgehog inhibitor therapy in the last 6 months
Female patients who are pregnant, intend to become pregnant or are nursing.
Uncontrolled intercurrent illness including, but not limited to, serious infection. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
Previous malignancy is not an exclusion provided that the other malignancy is considered under control, patient is not on concomitant anti-cancer drug therapy, and target lesions from melanoma are clearly defined for response assessment.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Genentech, Inc.
Collaborator