NCT05651828 · H. Lee Moffitt Cancer Center and Research Institute
Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Vismodegib 150 MG Oral Capsule
Vismodegib is a hedgehog signalling pathway target agent. Participants will self-administer the standard 150 mg dose by mouth.
Primary outcome measures
Time to Treatment Failure
Time frame: Up 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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 criteria
- 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.
Where
- Tampa, Florida
Collaborators
Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations