Clinical trial NCT02639117 (phase 1, status: completed)
Conditions: basal cell carcinoma
ICD codes: C44.510, C44.91, C44.01, C44.311, C44.511, C44.81, C44.41
Drugs: vismodegib
SMILES: CS(=O)(=O)C1=CC(Cl)=C(C=C1)C(=O)NC1=CC=C(Cl)C(=C1)C1=CC=CC=N1
Eligibility criteria:

        Inclusion Criteria

        Patients will be included in the study based on the following criteria:

          -  Male or non-childbearing potential females, at least 18 years of age (Female patients
             who meet at least one of the following criteria are defined as women of
             non-childbearing potential)

          -  ≥ 50 years old and naturally amenorrheic for ≥ 1 year

          -  Permanent premature ovarian failure confirmed by specialist gynecologist

          -  Previous bilateral salpingo-oophorectomy or hysterectomy

          -  XY karyotype, Turner's syndrome, or uterine agenesis

          -  Diagnosis of BCC with at least 4 nodular lesions that measure 0.5 cm to 5 cm in
             diameter, located on the head and neck, trunk or extremities.

          -  Diagnosis must be confirmed clinically at baseline with 1-2 lesions having been
             biopsied no sooner than 2 weeks prior to treatment.

          -  Patients who may have high burden of disease ie large lesions, who are non-surgical
             candidates or who refuse surgery.

          -  Non-surgical candidates, who may be able to undergo resection of selected single,
             individual lesion, but may not tolerate extensive surgery, may have many co
             morbidities, may be prone to complications.

          -  Patients in whom surgery or radiation therapy may be impractical

          -  Primary lesions may be acceptable for enrollment

          -  Within normal limit hematopoietic capacity, hepatic and renal function. Values outside
             those limits may be allowed at the digression of the PI, if they are determined as not
             clinically significant

          -  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

          -  Agreement not to donate blood or blood products during the study and for 7 months
             after discontinuation of vismodegib.

          -  Evidence of a personally signed and dated informed consent document indicating that
             the subject (or legally acceptable representative) has been informed of all pertinent
             aspects of the trial.

          -  Ability to understand and the willingness to sign a written informed consent document
             in English

        Exclusion Criteria:

          -  Women of childbearing potential

          -  Basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular)

          -  Any BCC that may require Mohs surgery for definitive control

          -  Subjects with porphyria's or known hypersensitivity to porphyrins

          -  Subjects with known photosensitivity diseases

          -  Subjects previously treated with a systemic photosensitizer within 4 months of
             screening date

          -  Subjects who desire to get pregnant a female of childbearing potential within the next
             1.5 years

          -  Uncontrolled concomitant 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.

          -  Life expectancy less than one year

          -  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, Ingenol mebutate (picato) to the selected treatment
             lesion sites.

          -  Subjects who have Gorlins syndrome

          -  Subjects who have received any type of solid organ transplant

          -  Subjects taking immunosuppressive medications at the screening visit.

          -  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.