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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients

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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

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