Advanced Basal Cell CarcinomaEarly Phase 1NCT05651828
Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
A Early Phase 1 study testing Vismodegib 150 MG Oral Capsule in people with Advanced Basal Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Basal Cell Carcinoma
- What is being tested?
- Vismodegib 150 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33617
Zeynep Eroglu, MD
Andrew Brohl, MD
About this study
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.
- Conditions
- Advanced Basal Cell Carcinoma
- Being tested
- Vismodegib 150 MG Oral Capsule
- Keywords
- Skin cancer
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vismodegib 150 MG Oral CapsuleDrug
Also called Erivedge
Vismodegib is a hedgehog signalling pathway target agent. Participants will self-administer the standard 150 mg dose by mouth.
| Study group | Role | What they receive |
|---|---|---|
| A: Continuous Vismodegib | Active comparator | Participants will receive continuous 150 mg by mouth daily vismodegib as per commercially available package insert. Receives: Drug: Vismodegib 150 MG Oral Capsule |
| Arm B: Fixed Intermittent Vismodegib | Experimental | Participants will receive intermittent 150 mg dose vismodegib by mouth with a 12 weeks on/8 weeks off regimen. Participants will take vismodegib for first 12 weeks, then off 8 weeks, and alternate in fixed cycles. Receives: Drug: Vismodegib 150 MG Oral Capsule |
| Arm C: Personalized Intermittent Vismodegib (Adaptive) | Experimental | Participants will start with an 8-week run in period with vismodegib 150 mg dose by mouth daily. Participants will take vismodegib for the first 8 weeks, then start personalized dosing based on specific model. Receives: Drug: Vismodegib 150 MG Oral Capsule |
| Arm D: Personalized Intermittent Vismodegib (TGI model) | Experimental | Participants will start with an 8-week run in period with vismodegib 150 mg dose by mouth daily. Participants will take vismodegib for the first 8 weeks, then start personalized dosing based on TGI model. Receives: Drug: Vismodegib 150 MG Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Failure
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.
Measured: Up to 36 months
Secondary outcomes (1)
Overall Response Rate
Overall Response Rate (ORR) is defined as the rate of the best overall response as complete response (CR) or partial response (PR). ORR will be measured using composite response criteria using RECIST 1.1 and/or externally visible tumors evaluated by bi-dimensional digital medical photography (WHO criteria).
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start23 Mar 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Zeynep Eroglu, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651828
- Sponsor's protocol ID
- MCC 21997
- Status last verified
- Mar 2026
- First submitted
- 7 Dec 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05651828
- Acronym / sponsor ID
- MCC 21997
- Conditions
- Advanced Basal Cell Carcinoma
- Keywords
- Skin cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: Continuous Vismodegib | Active comparator | Drug: Vismodegib 150 MG Oral CapsuleParticipants will receive continuous 150 mg by mouth daily vismodegib as per commercially available package insert. |
| Arm B: Fixed Intermittent Vismodegib | Experimental | Drug: Vismodegib 150 MG Oral CapsuleParticipants will receive intermittent 150 mg dose vismodegib by mouth with a 12 weeks on/8 weeks off regimen. Participants will take vismodegib for first 12 weeks, then off 8 weeks, and alternate in fixed cycles. |
| Arm C: Personalized Intermittent Vismodegib (Adaptive) | Experimental | Drug: Vismodegib 150 MG Oral CapsuleParticipants will start with an 8-week run in period with vismodegib 150 mg dose by mouth daily. Participants will take vismodegib for the first 8 weeks, then start personalized dosing based on specific model. |
| Arm D: Personalized Intermittent Vismodegib (TGI model) | Experimental | Drug: Vismodegib 150 MG Oral CapsuleParticipants will start with an 8-week run in period with vismodegib 150 mg dose by mouth daily. Participants will take vismodegib for the first 8 weeks, then start personalized dosing based on TGI model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vismodegib 150 MG Oral CapsuleAlso: ErivedgeVismodegib is a hedgehog signalling pathway target agent. Participants will self-administer the standard 150 mg dose by mouth. | Drug | A: Continuous Vismodegib, Arm B: Fixed Intermittent Vismodegib, Arm C: Personalized Intermittent Vismodegib (Adaptive), Arm D: Personalized Intermittent Vismodegib (TGI model) |
Primary outcome
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.
1 secondary outcome
Overall Response Rate
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeynep Eroglu, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vismodegib 150 MG Oral Capsule in people with Advanced Basal Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sy Olson-Mcpeek (813-745-0935, sy.olson-mcpeek@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Failure (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.