Votrient liver data meta-analysis of phase II and III RCC and STS studies (200277)

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:
  Meta-analysis
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Meta-analysis of 1500 pazopanib treated patients from phase II and III trials.
• 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:
  Hepatic impaired
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  The primary objective of these analyses will be to characterise the liver safety profile of pazopanib in subjects with locally recurrent and/or metastatic renal cell carcinoma or advanced or recurrent soft tissue sarcoma.
• Data analysis plan:
  A summary of liver re-challenges, adaptations and recovery will be provided. The re-challenge is defined as an ALT elevation, followed by treatment interruption and subsequently an ALT value of Grade 1 or below on or prior to re-starting study treatment, where the ALT elevation means ALT>3xULN during on-therapy window and ≤ 3xULN at baseline. The adaptation is defined as an ALT elevation followed by an ALT assessment returning to baseline grade or below without any dose interruption between the ALT elevation and normalisation. Recovery is defined as ALT Grade 1 or below for 2 consecutive visits or Grade 1 or below for one visit if subject discontinued and no subsequent ALT data are available.

Documents

Study results

Synop-200277