Recruiting
Early Phase 1

Basal Cell Carcinoma

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT05651828

Conditions

Advanced Basal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vismodegib 150 MG Oral Capsule

Study Details

Brief 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.

Conditions

Advanced Basal Cell Carcinoma

Study ID

NCT05651828

Start date

Mar 23, 2023

Status verified date

Mar, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: A: Continuous Vismodegib

Participants will receive continuous 150 mg by mouth daily vismodegib as per commercially available package insert.

experimental: Arm B: Fixed Intermittent Vismodegib

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.

experimental: Arm C: Personalized Intermittent Vismodegib (Adaptive)

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.

experimental: Arm D: Personalized Intermittent Vismodegib (TGI model)

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.

Interventions

Vismodegib 150 MG Oral Capsule

Vismodegib is a hedgehog signalling pathway target agent. Participants will self-administer the standard 150 mg dose by mouth.

Primary outcome measure

  • Time to Treatment Failure [ Time Frame: Up to 36 months ]

Central Contacts and Locations

Central contacts

Sy Olson-Mcpeek

813-745-0935sy.olson-mcpeek@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33617

Principal Investigator:

Zeynep Eroglu, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Skin cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-04-01.