Vismodegib in Treating Patients with High Risk Infiltrative/Morpheaform, Nodular and Superficial Basal Cell Carcinoma That Has Spread to Nearby Tissues or Lymph Nodes

Inclusion Criteria

• Evidence of a personally signed and data informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial
• Subjects who are willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• Has one or more clinically suspicious lesions for basal cell carcinoma (BCC) at pre-study screening visit that is/has: * A diameter >= 6 mm if located on the “mask areas” of face (central face, eyelids, eyebrows, periorbital, nose lips [cutaneous and vermillion], chin, mandible, preauricular and postauricular skin/sulci, temple, ear), genitalia, hands, or feet * A diameter >= 10 mm if located on cheeks, forehead, scalp, or neck * A diameter >= 20 mm if located on trunk and extremities Or has a lesion suspicious for locally advanced BCC defined as a lesion that: ** Is >= 10 mm, ** Has recurred following surgery or surgical resection would result in substantial deformity, and ** Has been deemed not appropriate for radiation
• Have a histologically-confirmed BCC prior to first dose of study drug at treatment initiation visit (baseline/day 1)
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at baseline/day 1 visit
• Males and females must agree that they have no desire or plan to conceive children in the future
• Female of reproductive potential must use 2 effective methods to avoid pregnancy during therapy and for 9 months after completing therapy. Effective methods must be used for 1 month before initiating therapy
• Male patients must use effective measures to avoid pregnancy in their partner at all times, even after vasectomy, during treatment and for 3 months after the last dose
• Agreement not to donate blood or blood products during the study and for 9 months after the last dose
• Subjects with basal cell nevus syndrome are eligible for enrollment

Exclusion Criteria

• Women who are pregnant or lactating, or planning pregnancy while enrolled in the study
• History of prior treatment with vismodegib or any Hh pathway inhibitor
• Have evidence of clinically significant and unstable diseases or conditions such as cardiovascular, immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities. 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
• Have any dermatological disease at treatment site that the investigator thinks may be exacerbated by treatment with vismodegib or cause difficulty with examination (e.g., psoriasis, eczema)
• The target lesion identified at pre-study screening visit has been determined to be metastatic (m)BCC by radiological assessment prior to first dose of study drug
• Inability or unwillingness to swallow capsules
• Have a history of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged to be clinically significant by the investigator within 4 weeks prior to first dose of study drug
• Have a history of infection requiring antimicrobial therapy within 2 weeks prior to first dose of study drug
• Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to first dose of study drug
• Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses
• Participation in other study using an investigational or experimental therapy or procedure within 4 weeks or 5 half-lives (whichever is longer) before the study begins 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 who are investigational site staff members or subjects who are sponsor employees directly involved in the conduct of the trial
• A subject who, in the opinion of the investigator or sponsor, will be uncooperative or unable to comply with study procedures
• Subjects (male and female) who desire to conceive in the future