PGx7607: PGx evaluation of pyrexia by meta-analysis of melanoma subjects from BRF113710, BRF113929, BRF113683, MEK115306 and MEK116513 (202050)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Pharmacogenetics study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Pharmacogenetics study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DABRAFENIB

  TRAMETINIB

Population studied

• Short description of the study population:
  Caucasian melanoma subjects treated with dabrafenib or a combination of dabrafenib and trametinib.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Melanoma patients
• Estimated number of subjects:
  579

Study design details

• Main study objective:
  The study objective is to identify germline genetic associations with pyrexia by meta-analysis of subjects treated with dabrafenib or a combination of dabrafenib and trametinib from studies BRF113710, BRF113929, BRF113683, MEK115306 and MEK116513
• Data analysis plan:
  A meta-analysis will be conducted on Caucasian melanoma subjects from five metastatic melanoma studies (BRF113710, BRF113929, BRF113683, MEK115306, and MEK116513).