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.
Parallel
Vismodegib 150 MG Oral Capsule
DrugVismodegib is a hedgehog signalling pathway target agent. Participants will self-administer the standard 150 mg dose by mouth.
Time to Treatment Failure
Time to treatment failure (defined as the time from the day of first dose of study drug to the first day of treatment with another regiment or with the same regimen in a non-adaptive fashion) or a personalized vs fixed intermittent vs continuous dosing of vismodegib.
Overall Response Rate
Overall Response Rate (ORR) is defined as the rate of the best overall response as complete response (CR) or partial response (PR). ORR will be measured using composite response criteria using RECIST 1.1 and/or externally visible tumors evaluated by bi-dimensional digital medical photography (WHO criteria).
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Genentech, Inc.
Collaborator
