Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma

This study is looking at different ways to give Vismodegib, an oral capsule, to people with advanced basal cell carcinoma (a type of skin cancer). Researchers want to see how well four different dosing schedules work and how well people tolerate them. Two of these schedules are personalized (adjusted for you), one is a fixed intermittent schedule, and one is continuous. You could be eligible if you are 18 or older and have locally advanced basal cell carcinoma. The study will measure how long it takes for treatment to stop working, for up to 36 months. The current status of this study is unclear, and it plans to enroll 34 participants.

Study design: This is an interventional study comparing four different dosing schedules of Vismodegib. It plans to enroll 34 participants.
What's involved: Participants will self-administer the 150 mg Vismodegib capsule by mouth. The specific schedule of visits, tests, or procedures is not detailed.
Compensation: Not stated in the trial record.
Follow-up: The study will measure how long it takes for treatment to stop working, for up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma

Recruiting

EARLY_PHASE1Ages 18+InterventionalTreatment

H. Lee Moffitt Cancer Center and Research Institute

~34 participants

Updated 2026-04-01 on ClinicalTrials.gov

What's tested:Vismodegib 150 MG Oral Capsule

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Time to Treatment Failure

Measured over Up to 36 months

Conditions

Advanced Basal Cell Carcinoma

Where it's being run

1 sites across 1 states

Florida1

Study leadership

Zeynep Eroglu, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Sy Olson-Mcpeek

[email protected]

813-745-0935

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 patients must agree not to become pregnant or donate lactation during treatment and until 24 months after stop of treatment. Male patients must use condoms at all times, even after a vasectomy, during sexual intercourse with female partners of reproductive potential during treatment with vismodegib and for 3 months after the last dose to avoid exposing a pregnant partner and unborn fetus to vismodegib. Male patients must agree not to donate sperm during the study and for 3 months after discontinuation of vismodegib.

Exclusion

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.

Inability or unwillingness to swallow capsules.

Any known allergy, hypersensitivity or severe reaction to vismodegib or any of the ingredients

Co-treatment with a statin or St. John's Wort.

What this trial measures

Time to Treatment FailureUp to 36 months
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.

Trialytics