Male and female patients at least 18 years of age with histologically confirmed diagnoses of locally advanced BCC MedDRA version: 18.0 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ERIVEDGE
Product Name: ERIVEDGE
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: VISMODEGIB
CAS Number: 879085-55-9
Current Sponsor code: GDC-0449
Other descriptive name: VISMODEGIB
Sponsors
CHRU De Lille
Eligibility
Sex/Gender
All
Inclusion 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. 3.Written informed consent 4.Age = 18 years 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 [SGOT]) and alanine transaminase (ALT [SGPT]) = 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 treatement. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the proportion of BCC patients (in intent to treat) with down-staging of surgical procedure after Vismodegib neoadjuvant treatment (with a maximum treatment period of 10 months). ;Secondary Objective: 1.Estimation of the percentage of patients with locally advanced BCC having a down-staging of surgical procedures after at least 4 months of treatment with Vismodegib 2.Assessment of clinical benefits for patients treated with Vismodegib by an Independent panel of experts 3.Medico-economical assessment of the related medical care 4.Assessment of treatment toxicity 5.Quality of life assessment 6. Evaluation of the tumor recurrence rate after 3 years of follow-up;Primary end point(s): To assess the change in surgery stages (comparison of the surgery stages before and after the treatment with Vismodegib;Timepoint(s) of evaluation of this end point: End of treatment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Percentage of patients with locally advanced BCC with down-staging of surgical procedures after at least 4 months treatment with Vismodegib 2.Gravity index related to the surgical or functional results (global score) and score of the clinical benefits at BOR. 3.Comparison of the costs of the usual care and those induced by the of the treatment with Vismodegib 4.The NCI-CTCAE, v4.0 5.Quality of life assessment using the Skindex-16 Quality of Life 6. Evaluation of the tumor recurrence rate after 3 years of follow-up;Timepoint(s) of evaluation of this end point: 1.End of treatment visit 2.End of study 3.Each study visit 4.Quality of life assessment during the treatment period (cycle 1, cycle 3 and cycle 6) and end of treatment visit 5. Tumor recurrence rate after 3 years of follow-up | — |
Countries
France
Contacts
Public ContactMIRAKOVSKA Liubinka & MEDDOUR Damia
Centre Hospitalier Univeristaire De Lille
Outcome results
None listed