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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Vismodegib is a hedgehog signalling pathway target agent. Participants will self-administer the standard 150 mg dose by mouth.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGTime 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.
Time frame: Up to 36 months
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).
Time frame: Up to 36 months
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