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New treatment option for Advanced Basal Cell Carcinoma
Official title Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
ClinicalTrials.gov ID: NCT05651828
What this study is testing
What is Vismodegib 150 MG Oral Capsule?
Vismodegib 150 MG Oral Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced basal cell carcinoma.
Also referred to as Erivedge.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Previous malignancy is not an exclusion provided that the other malignancy is considered under control, patient is not on concomitant anti-cancer...
- Inability or unwillingness to swallow capsules.
- Any known allergy, hypersensitivity or severe reaction to vismodegib or any of the ingredients
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.