Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. * Patients may have received prior hedgehog inhibitor therapy (if more than 6 months prior) or other systemic treatments for basal cell carcinoma in the past. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Agreement not to donate blood or blood products during the study and for 24 months after discontinuation of vismodegib. * Patients must have adequate hepatic, renal, and bone marrow function as defined in the protocol. * Partic