PGx447:Exploratory genetic analysis of pazopanib (GW786034) related diarrhea in patient with RCC(VEG102616,VEG105192,VEG107769) (116054)

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:
  Pharmacogenetic study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Pharmacogenetic 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:
  The genetic analysis population will consist of subjects enrolled in clinincal studies VEG102616, VEG105192, and VEG107769 who provided written informed consent for genetic research, provided a blood sample for genotyping and were successfully genotyped for at least one of the genetic markers under study, have valid phenotype data and pass subject QC.; ; a. Subject number includes only those who received pazopanib.; b. Subjects provided informed consent and a blood sample for pharmacogenetic research. The clinical data used in this analysis were from the April 2008 data cut-off for VEG102616 and the May 2008 data cut-off for VEG105912 and VEG107769.; c. VEG107769 was an open-label extension to VEG105192 providing the option for patients who developed progressive disease while on placebo to receive pazopanib treatment.
• 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:
  397

Study design details

• Main study objective:
  The objective of this analysis is to investigate if genetic markers from 38 candidate genes or other markers from across the genome are associated with incidence of diarrhoea in RCC patients treated with pazopanib in studies VEG102616, VEG105192 and VEG107769.
• Outcomes:
  The primary endpoint is the diarrhoea outcome status defined as case or control, The secondary endpoint is diarrhoea toxicity grade levels from 1 to 5 and grade 0 for the controls, defined as an ordinal categorical variable.
• Data analysis plan:
  The Case-Control analyses will be performed on the binary outcome measure (diarrhoea status), using logistic regression analysis, the ordinal data analyses will be performed on ordinal categorical diarrhoea toxicity grade levels, using proportional odds model, if the marker meets the p-value threshold for suggestive evidence in the primary anlaysis.

Documents

Study results

116054 results summary