Status:
COMPLETED
A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Part I was a double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrat...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00961896
Start Date
July 1 2009
Last Update
November 3 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Graz, Austria
2
Novartis Investigator Site
Vienna, Austria
3
Novartis Investigative Site
Zurich, Switzerland