PGX7550: PGx Investigation of Pyrexia by Meta-Analysis of Dabrafenib/Trametinib Melanoma Studies BRF113710, BRF113929, BRF113683 and MEK115306 (200997)

Study type

• Study topic:
  Disease /health condition

  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
• Medical condition to be studied:
  Malignant melanoma

Population studied

• Short description of the study population:
  Malignant melanoma patients who received Dabrafenib/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:
  Malignant melanoma patients
• Estimated number of subjects:
  407

Study design details

• Main study objective:
  The primary objective of this study is to further follow up previously identified suggestive associations between pyrexia and a genetic variant in IL28B (rs8099917) by meta-analysis of melanoma subjects from BRF113710, BRF113929, BRF113683 and MEK115306
• Data analysis plan:
  The initial PGx analysis will focus on the metastatic melanoma subjects from MEK115306 who met the definition of a case or control. These subjects will be meta-analyzed along with the 3 study populations BRF113710, BRF113929, and BRF113683.