PGx6652: Genetic Evaluation of Pazopanib –Related Hepatotoxicity (117365)

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:
  PAZOPANIB

Population studied

• Short description of the study population:
  Patients with pazopanib-related hepatotoxicity who were evaluated for biomarkers.
• 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)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The objective is to identify genetic markers associated with pazopanib-related hepatotoxicity
• Outcomes:
  Occurance of serious liver injury, maximum ALT measured within the on-therapy window, and time-to-event defined as the time from initiation of pazopanib treatment until the first on-therapy event
• Data analysis plan:
  For the candidate gene analysis, association between candidate gene alleles/genotypes and the case/control endpoint will be tested using the logistic regression analysis with appropriate adjustment of covariates. For the GWAS analysis, association between the continuous form of endpoints and genetic variants across the entire genome will be tested using linear and Cox regressions.

Documents

Study results

117365-Clinical-Study-Result-Summary