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A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Not Recruiting

Trial ID: NCT01327053

Purpose

This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.

Official Title

Phase II, Randomized Double-blind Study of Efficacy and Safety of Two Dose Levels of LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Stanford Investigator(s)

Anthony Oro, MD, PhD
Anthony Oro, MD, PhD

Eugene and Gloria Bauer Professor

Eligibility


Inclusion Criteria:

   - Patients with locally advanced BCC and metastatic BCC

   - Patients with adequate bone marrow, liver, and renal function

Exclusion Criteria:

   - Patients who had had major surgery within 4 weeks of initiation of study medication

   - Patients unable to take oral drugs or with lack of physical integrity of the upper
   gastrointestinal tract, or known malabsorption syndromes.

   - Patients with concurrent medical conditions that may interfere or potentially affect
   the interpretation of the study.

   - Patients with neuromuscular disorders or are on concurrent treatment with drugs that
   may cause muscle damage.

   - Patients who were on concurrent therapy with other anti-neoplastic agents.

   - Patients who had taken part in an experimental drug within 4 weeks of initiation of
   study medication.

   - Pregnant or nursing (lactating) women

   - Women of child bearing potential unwilling to use 2 forms of highly effective
   contraception throughout the study and for 3 months after the last treatment

   - Fertile males not willing to use condoms throughout the study and for 3 months after
   the last treatment.

   - Patients who were unwilling or unable to comply with the protocol.

Intervention(s):

drug: LDE225

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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