Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring advanced BCC, high risk, locally advanced Read More

Inclusion Criteria:

1. A signed and data informed consent
2. Willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
3. 18 years of age or older at time of informed consent

4. Have one or more clinically suspicious lesions for BCC at Pre-Study screening Visit that has:

   1. a diameter ≥ 6 mm if located on the "mask areas" of face (central face, eyelids, eyebrows, periorbital,nose,lips,chin,mandible,preauricular and postauricular skin/sulci,temple,ear),genitalia,hands,or feet
   2. a diameter ≥ 10 mm if located on cheeks,forehead,scalp,or neck

   3. a diameter ≥ 20 mm if located on trunk and extremities

      or has a lesion suspicious for locally advanced BCC defined as a lesion that:

   4. is ≥ 10 mm,
   5. has recurred following surgery or surgical resection would result in substantial deformity, and
   6. has been deemed not appropriate for radiation.
5. Have a histologically-confirmed BCC prior to first dose of study drug
6. Have an Eastern Cooperative Oncology Group performance status of 2 or less at Baseline
7. Female of reproductive potential must use 2 effective methods to avoid pregnancy during therapy and for 7 months after completing therapy
8. Male patients must use effective measures to avoid pregnancy in their partner at all times during treatment and for 2 months after the last dose
9. Agree not to donate blood or blood products during the study and for 7 months after the last dose
10. Subjects with Basal Cell Nevus Syndrome are eligible for enrollment

Exclusion Criteria:

1. Women who are pregnant, lactating, or planning pregnancy while in the study
2. History of prior treatment with vismodegib or any Hh Pathway Inhibitor
3. Evidence of clinically significant and unstable diseases or conditions; Subjects with clinically stable chronic medical conditions will be allowed to enter the study
4. Any dermatological disease at treatment site that the investigator thinks may be exacerbated by treatment with vismodegib or cause difficulty with examination
5. The target lesion identified at Pre-study Screening visit has been determined to be mBCC by radiological assessment prior to first dose of study drug
6. Inability or unwillingness to swallow capsules
7. History of infection requiring hospitalization, IV antimicrobial therapy, or is otherwise judged to be clinically significant by the investigator within 4 wks prior to first dose of study drug
8. History of infection requiring antimicrobial therapy within 2 wks prior to first dose of study drug
9. History of alcohol or substance abuse, unless in full remission for greater than 6 months prior to first dose of study drug
10. Known to be infected with human immunodeficiency virus, hepatitis B or hepatitis C viruses
11. 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
12. 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 in the judgment of the investigator
13. Subjects who are study site staff members or who are Sponsor employees directly involved in the conduct of the trial
14. A subject who, in the opinion of the investigator or sponsor, will be uncooperative or unable to comply with study procedures