Prospective non interventional study of cabozantinib tablets in adults with advanced renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy (Cassiope)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, international, multicentre study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XE26) cabozantinib

  cabozantinib
• Medical condition to be studied:
  Renal cell carcinoma

Population studied

• Short description of the study population:
  Adult patients aged 18 years or older diagnosed with advanced renal cell carcinoma (RCCC) received treatment with at least one prior vascular endothelial growth factor (VEGF)-targeted therapy.; Inclusion criteria:; (1) Age ≥18 years old;; (2) Has a diagnosis of advanced RCC;; (3) Has received at least one prior VEGF-targeted therapy;; (4) For whom the treating physician has decided to start treatment with cabozantinib tablets prior to inclusion;; (5) No previous exposure to cabozantinib prior to inclusion;; (6) Not concurrently involved in an interventional study;; (7) Consents to participate in this noninterventional study.; There are no exclusion criteria for this study.
• 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:
  Other
• Special population of interest, other:
  Patients with renal cell carcinoma
• Estimated number of subjects:
  689

Study design details

• Main study objective:
  To describe the pattern of dose interruptions, reductions or discontinuations of cabozantinib due to adverse events in clinical practice when used as a second or third and later line therapy.
• Outcomes:
  Proportion of patients with dose modifications due to adverse events based on investigator’s decision (temporary interruption, dose reduction or discontinuation) when cabozantinib is used as a second line therapy, or third and later line therapy. Description of the use of cabozantinib in real-life settings, effectiveness, safety and health care resource utilization associated with management of treatment related AEs.
• Data analysis plan:
  As this is a non-interventional study, no formal statistical testing will be performed and all the analyses will be primarily descriptive in nature. When appropriate and unless otherwise specified, 2-sided 95% confidence interval (CIs) will be displayed and if p values are presented, they will be for exploratory purposes only. The primary endpoint is the proportion of subjects with dose modifications due to AEs based on the investigator’s decision (temporary interruption, dose reduction or discontinuation). The primary analysis of the primary endpoint will be summarised descriptively for each line of treatment (second line or third and later line) and in total with their associated 2-sided 95% CIs based on the Clopper Pearson method and using the Primary Safety population.

Documents

Study results

F-FR-60000-001_CSR Abstract_Redacted (002)

Study report

F-FR-60000-001_synopsis_06Nov2020