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

Trial ID or NCT#

NCT01327053

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Patients with locally advanced BCC and metastatic BCC - Patients with adequate bone marrow, liver, and renal function
Exclusion Criteria:
  1. - 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.

Investigator(s)

Anthony Oro, MD, PhD
Anthony Oro, MD, PhD
Dermatologist, Hair loss specialist, Dermatologic oncologist, Cutaneous oncology specialist, Skin stem cell specialist
Eugene and Gloria Bauer Professor

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061