RECRUITING

Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma

Conditions

Advanced Basal Cell Carcinoma Skin cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma

Quick Facts

Study Start:2023-03-23

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05651828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Zeynep Eroglu, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33617

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Zeynep Eroglu, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-23

Study Completion Date2029-12

Study Record Updates

Study Start Date2023-03-23

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

Skin cancer

Additional Relevant MeSH Terms

Advanced Basal Cell Carcinoma