Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma (NCT05651828) | Clinical Trial Compass
RecruitingEarly Phase 1
Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
United States34 participantsStarted 2023-03-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
* Participants must have a negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for ≥1 year.
* Women of reproductive potential are required to use two forms of acceptable contraception (including one acceptable barrier method with spermicide) during therapy and for 24 months after completing therapy.
* Female pa…
What they're measuring
1
Time to Treatment Failure
Timeframe: Up to 36 months
Trial details
NCT IDNCT05651828
SponsorH. Lee Moffitt Cancer Center and Research Institute