A non-interventional, multi-national, multi-center post authorization safety study (PASS) to assess the long term safety and tolerability of Odomzo (sonidegib) administered in patients with locally advanced cell carcinoma (laBCC). (PASS ODOMZO (Sonidegib))

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SONIDEGIB
• Medical condition to be studied:
  Basal cell carcinoma

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  1. Collect real-world safety data on the use of sonidegib in adult patients with laBCC2. Document major safety parameters such as on-treatment deaths, adverse events (AEs)/serious adverse events (SAEs), and discontinuation secondary to AEs.
• Outcomes:
  Proportion of patients with AEs/SAEs including on treatment deaths and discontinuation due to AEs/SAEs, Proportion of patients with AEs of special interest (AESI) or populations, in pateints with:• relevant polymorphism• ≥65 yrs.• hepatic or renal impairment• Female patients with child bearing potential using anticonceptives• anemia (hemoglobin <9 g/dL), recent myocardial ischemia or cardiac failure• concomitant medications with known risk of creatine kinase elevation
• Data analysis plan:
  Descriptive summaries and listings of the data will be provided for yearly status update and safety reports.The final analysis will be performed when the last patient has completed the 3 year observation period after enrollment, or discontinued earlier, whichever comes first, primary, secondary and exploratory endpoints will be analyzed at this time point.