Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called vismodegib to see how well different dosing schedules work for patients with advanced basal cell carcinoma, a type of skin cancer. Researchers want to find out if personalized dosing plans that adjust based on how well patients tolerate the treatment are more effective than fixed schedules that give the same dose continuously or intermittently. The goal is to improve how patients respond to the treatment while minimizing side effects.

To participate in this study, you must be at least 18 years old and have a confirmed diagnosis of advanced basal cell carcinoma. You should have at least one measurable tumor that doctors can assess. The trial is open to both men and women, and there are no upper age limits. Participants will receive the medication according to one of the study's dosing schedules and will be monitored closely for any effects. It’s important to know that women who can become pregnant will need to use two forms of birth control during the study and for two years afterward to avoid any risks to an unborn child. If you’re interested in joining this trial, speak to your doctor to see if it’s right for you.

Gender

ALL

Eligibility criteria

• 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.