Trial Information
A 2-part, Randomized Study to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Topical Administrations of LDE225 (a Specific Smoothened Inhibitor) on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients
Inclusion Criteria:
- Patients with multiple basal cell carcinomas and Gorlin syndrome, or patients with
multiple basal cell carcinomas and a mutation in the PTCH1 gene at chromosome 9q22.3
Exclusion Criteria:
- Previous treatment of the BCC's that are selected for treatment.
- Any systemic treatment which is known to affect BCCs esp. cytostatic treatments,
retinoids and photodynamic treatments.
Other protocol defined Incl./Excl. criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Clinical evaluation of BCC tumors (complete response)
Outcome Time Frame:
4 weeks/6 weeks/9 weeks
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Austria: Agency for Health and Food Safety
Study ID:
CLDE225B2203
NCT ID:
NCT00961896
Start Date:
July 2009
Completion Date:
Related Keywords:
- Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients
- Basal Cell Carcinoma
- Gorlin Syndrome,
- Gorlin-Goltz Syndrome,
- Basal Cell Nevus Syndrome,
- Nevoid Basal Cell Carcinoma Syndrome,
- Basal Cell Carcinoma Nevus Syndrome
- Basal Cell Nevus Syndrome
- Eye Abnormalities
- Tooth Abnormalities
- Carcinoma
- Carcinoma, Basal Cell