A Pilot Open-Label Study to Examine the Safety and Efficacy of Oral LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma Who Have Been Previously Treated With Non-LDE225 Smoothened Inhibitor(s)

This is a prospective single-center, open label, pilot study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma. Primary Objectives: ? To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor. Secondary Objectives: - To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (Gii 1, 2, Patched 1,2 and Ki67) in individuals which are non-na"ive to Smo inhibitors other than LDE225, at baseline and at end-of-treatment - To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage - To assess the overall survival rates of individuals with locally advanced BCC or metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with LDE225

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : LDE225

Phase: N/A

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

1. Age 18 years or older. 2. Histologically documented diagnosis of basal cell carcinoma deemed to be locally advanced or metastatic who have previously received a non-LDE225 Smo inhibitor. 3. WHO performance status <= 2 4. At least one measurable site of disease (as defined by Response Evaluation Criteria in Solid Tumors), or other disease specific response assessment criteria, as appropriate. State age restriction and/or gender/race-ethnic restrictions. 5. Patients with adequate bone marrow, liver and renal function, as specified below: - Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L - Hemoglobin (Hgb) >= 9 g/dL - Platelets >= 80 x 10^9/L - Serum total bilirubin <= 1.5 x ULN(upper limit of normal) - AST and ALT <= 2.5 x ULN or <= 5 x ULN if liver metastases are present - Plasma creatine phosphokinase (CK) < 1.5 x ULN - Serum creatinine <= 1.5 x ULN or 24-hour clearance >= 50ml/min 6. Written informed consent obtained prior to any screening procedures

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Contact information

Primary Contact:

Shruthi Rangaraj 650-721-7159

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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