Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.
Enrolled patients will receive continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg (in accordance with the product SmPC) per administration. One cycle of therapy will be defined as 28 days of treatment. The treatment will be renewed once a month depending on the product tolerance. The trial will consist of a Screening Period (Day -28 to -1), a Treatment Period (Day 1 to BOR), one End of Treatment Visit, one Surgery Visit and 8 Safety Follow-Up Visits after the last dose of Vismodegib (+/- 5 days). Day 1 of the study will be defined as the first day a patient receives Vismodegib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
CHU de Besançon
Besançon, Besançon, France
Hôpital St André
Bordeaux, Bordeaux, France
CH de Boulogne sur mer
the change in surgery stages
comparison of the surgery stages before and after the treatment with Vismodegib according to specific surgery stage table
Time frame: Between baseline and maximum 10 months of treatment
Number of patients with locally advanced BCC with down-staging of surgical procedures with Vismodegib
Time frame: from 4 to 10 months of treatment
Gravity index related to the surgical or functional results (global score)
Time frame: At maximum 10 months of treatment
Score of the clinical benefits at BOR
Time frame: At maximum 10 months of treatment
Assessment of treatment toxicity according to NCI-CTC, v4.0
National Cancer Institute - CommonToxicity Criteria (NCT-CTC) for the recognition and grading severity of adverse effects of chemotherapy
Time frame: 2 months after the surgery and maximum 12 months after the Vismodegib initiation
Quality of life assessment by Skindex-16 questionnaire
Time frame: At screening, at 3 months, at 6 months of treatment
the tumor recurrence rate
Time frame: at 3 years of follow-up
the cytological response by biopsy
Time frame: from 4 to 10 months of treatment
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Boulogne-sur-Mer, Boulogne Sur Mer, France
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...and 7 more locations