Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention
Condition: Basal Cell Carcinomas
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: Vismodegib; Placebo
Intervention description: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.; Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a single site double blinded Phase II study to evaluate the chemopreventative
      effectiveness of vismodegib in the treatment of subjects at high risk for developing basal
      cell carcinomas (BCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent document indicating that the subject (or legally
             acceptable representative) has been informed of all pertinent aspects

          -  Comply with scheduled visits, treatment plan, laboratory tests, and other study
             procedures.

          -  At least 18 years of age at the time of informed consent.

          -  History of 3 or more biopsy confirmed BCCs in the preceding 2 years, calculated from 2
             years prior to the screening visit.

          -  No active skin cancers.

          -  Women of reproductive potential must agree to use two forms of acceptable
             contraception

          -  Male subjects must agree to use condoms at all times, even after a vasectomy, during
             sexual intercourse with female partners of reproductive potential during treatment
             with vismodegib and for 2 months after the last dose to avoid exposing a pregnant
             partner and the unborn fetus to vismodegib.

          -  Male patients must agree not to donate sperm during the study and for 2 months after
             discontinuation of vismodegib

          -  Agreement not to donate blood or blood products during the study and for 7 months
             after the last dose.

          -  Ability to understand and the willingness to sign a written informed consent document
             in English

        Exclusion Criteria:

          -  Women who are pregnant or lactating, or planning pregnancy while enrolled in the study
             or for 7 months after the last dose of the study drug.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements. Subjects with clinically stable chronic medical conditions
             including, but not limited to, controlled hypertension, diabetes mellitus type II,
             hypercholesterolemia, or osteoarthritis, will be allowed to enter the study.

          -  Inability or unwillingness to swallow capsules.

          -  Have a history of alcohol of substance abuse, unless in full remission for greater
             than 6 months prior to the screening visit (Day 0) when the consent form is signed.

          -  Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis
             C viruses.

          -  Currently receiving vismodegib, biologics or chemotherapy

          -  Currently undergoing treatment with photodynamic therapy, topical chemotherapy agents
             including Imiquimod, fluorouracil

          -  Subjects who have Gorlins syndrome

          -  Subjects who have received any type of solid organ transplant

          -  Subjects taking immunosuppressive medications at the screening visit. (Day 0)

          -  Participation in other study using an investigational or experimental therapy or
             procedure within 4 weeks or 5 half-lives (whichever is longer) before the screening
             visit and/or during study participation. Subjects cannot participate in studies of
             other investigational or experimental therapies or procedures at any time during their
             participation in this study.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study.

          -  Subjects unable or unwilling to comply with the study visit schedule and requirements
             of the study

          -  Subjects unable to speak and read the English language

          -  A subject who, in the opinion of the sponsor-investigator will be uncooperative or
             unable to comply with study procedures.