Clinical trial NCT02667574 (phase 2, status: active, not recruiting)
Conditions: basal cell carcinoma
ICD codes: C44.510, C44.91, C44.01, C44.311, C44.511, C44.81, C44.41
Drugs: erivedge
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:

          1. Patients with BCC, which surgery stage is A, B or C (cf. Appendix 3: Definition of
             surgery stages), with a diameter ≥ 3cm in zones at intermediate risk of tumor
             recurrence and a BCC with a diameter of ≥ 2 cm in the zones at higher risk of tumor
             recurrence. According to the HAS recommendations, two zones are taken into
             consideration:

               -  Zones at intermediate risk of tumor recurrence: forehead, cheek, chin, neck and
                  scalp

               -  Zones at higher risk of tumor recurrence: nose and periorificial sites of the
                  cephalic extremity

          2. The decision to include the patient in this study should be taken during the
             Pluridisciplinary Committee Meeting (RCP). During this RCP, the radiotherapy should be
             considered as an inadequate treatment. (If the radiotherapist is absent during the
             meeting, his opinion should be documented in the patient's medical record).

          3. Written informed consent

          4. Age ≥ 18 years old

          5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2

          6. At least one histologically confirmed lesion...

          7. Patients with Gorlin syndrome may enroll in this study but must meet the other
             inclusion criteria

          8. Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1)

          9. Adequate organ function, as evidenced by the following laboratory results:

               -  Hemoglobin > 8.5 g/dL

               -  Granulocyte count ≥ 1000/μL

               -  Platelet count ≥ 75,000/μL

               -  Aspartate transaminase (AST ) and alanine transaminase (ALT) ≤ 3 × upper limit of
                  normal (ULN)

               -  Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with documented
                  Gilbert syndrome

         10. Negative serum pregnancy test within 7 days prior to commencement of dosing in
             premenopausal women. Women of non-childbearing potential may be included if they are
             either surgically sterile or have been postmenopausal for ≥ 1 year.

         11. Women of childbearing potential must use one highly-effective method of contraception
             and one barrier method of contraception during treatment and for 24 months after the
             final dose. Highly-effective methods of contraception are defined as those which
             result in a low failure rate (i.e., less than 1% per year) when used consistently and
             correctly (e.g., implants, injectables, or intra-uterine devices; refer to Appendix 8
             for more details). At the discretion of the Investigator, acceptable methods of
             contraception may include total abstinence. (Periodic abstinence [e.g., calendar,
             ovulation, symptothermal, and postovulation methods] and withdrawal are not acceptable
             methods of contraception.).

         12. For male patients with female partners of childbearing potential, agreement top use a
             condom with spermicide, even after vasectomy, during sexual intercourse with partners
             while being treated with Vismodegib and for two months after completion of study
             treatment

         13. For male patients, agreement not to donate semen during the study and for 24 months
             after discontinuation of Vismodegib

         14. Agreement not to donate blood or blood products during the study and for at least 24
             months after discontinuation of Vismodegib.

         15. Life expectancy > 12 weeks

         16. Patients covered by a Health Insurance System

        Exclusion Criteria:

          1. Inability or unwillingness to swallow capsules

          2. Patients with BCC situated out of the head or the neck area

          3. Pregnancy or lactation

          4. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other
             targeted therapy or photodynamic therapy

          5. Chemotherapy within 4 weeks prior to enrollment

          6. Participation in another clinical trial within 4 weeks prior to enrollment

          7. Radiotherapy within 6 months prior to enrolment

          8. Metastatic BCC

          9. Uncontrolled medical illnesses such as infection requiring treatment with intravenous
             antibiotics.

         10. History of other disease, metabolic dysfunction, physical examination finding, or
             clinical laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates use of an investigational drug or that might affect interpretation of
             the results of the study or that renders the patient at high risk from treatment
             complications.

         11. Patients with a rare hereditary problem of galactose intolerance, primary hypolactasia
             or glucose-galactose malabsorption (according to the product SmPC).

         12. Patients unable or unwilling to comply with the protocol requirements

         13. Patients in emergency situations

         14. Patients kept in detention