Know Cancer

or
forgot password

A Phase II, Double-blind, Randomized, Proof-of-Concept, Dose-ranging Trial Evaluating the Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Adult Patients With Nevoid Basal Cell Carcinoma Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Basal Cell Carcinoma, Gorlin Syndrome, Nevoid Basal Cell Carcinoma Syndrome

Thank you

Trial Information

A Phase II, Double-blind, Randomized, Proof-of-Concept, Dose-ranging Trial Evaluating the Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Adult Patients With Nevoid Basal Cell Carcinoma Syndrome


Inclusion Criteria:



- Patients with multiple basal cell carcinomas (at least two) and typical presentation
of NBCCS.

- Female patients must be women of non-childbearing potential (WONCBP).

Exclusion Criteria:

- Use of any topical treatment to treat BCCs, including prescription and over the
counter in the 4 weeks prior to first dose of study drug.

- Use of photodynamic therapy (PDT), radiation or systemic treatment known to affect
BCCs or neoplasm in the 12 weeks prior to first dose of study drug.

- Patients receiving medications that are recognized to cause rhabdomyolysis or
patients with a prior history of rhabdomyolysis.

- Patients with a histologically confirmed diagnosis of locally advanced or metastatic
BCC.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Measure: Clinical evaluation of BCC tumors (complete response)

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Canada: Health Canada

Study ID:

CLDE225B2209

NCT ID:

NCT01350115

Start Date:

April 2011

Completion Date:

October 2012

Related Keywords:

  • Basal Cell Carcinoma
  • Gorlin Syndrome
  • Nevoid Basal Cell Carcinoma Syndrome
  • Basal Cell Carcinoma
  • Gorlin Syndrome,
  • Gorlin-Goltz Syndrome,
  • Basal Cell Nevus Syndrome,
  • Nevoid Basal Cell Carcinoma Syndrome,
  • Basal Cell Carcinoma Nevus Syndrome
  • Smo inhibitor,
  • Hedgehog pathway inhibitor
  • BCCs
  • Basal Cell Nevus Syndrome
  • Eye Abnormalities
  • Tooth Abnormalities
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location