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Personalized dosing of skin cancer drug aims to reduce side effects

NCT ID NCT05651828

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares four different dosing schedules of the drug vismodegib in people with advanced basal cell carcinoma. The goal is to see if personalized, intermittent dosing works as well as or better than standard continuous dosing while being easier to tolerate. About 34 adults with advanced skin cancer will take the drug at home and be monitored for how long the treatment works and how the tumors respond.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vismodegib (Erivedge) oral capsule
What this could lead to
If successful, this could lead to a more tolerable and effective way to manage advanced basal cell carcinoma with fewer side effects.
What could go wrong
This is a very early phase 1 trial with only 34 participants, so results may not apply broadly. The personalized dosing schedules may not improve outcomes over standard dosing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33617, United States

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