Observational Study of Real World Effectiveness Data and Safety in Patients Receiving Pazopanib With Advanced or Metastatic Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2017-07-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a global, multi-centre, long-term, prospective, observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated for the first time with pazopanib. The study is designed to enroll approximately 700-1000 patients in over the course of an enrollment period of approximately 18 months.There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 30 months or until premature discontinuation (i.e., due to death, withdrawal of consent, lost to follow-up or study termination).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Patients eligible for enrolment in the study must meet all of the following criteria:

• Age ≥ 18 years at enrollment

• Documented diagnosis of advanced and/or metastatic clear cell or predominantly clear cell RCC

• Clinical decision made to initiate treatment with pazopanib prior to enrollment in the study, but within 30 days of enrollment

• Willing and able to provide written informed consent

Exclusion Criteria:

• Patients meeting any of the following criteria must not be enrolled in the study:

• Patients currently participating in any interventional clinical trials in which treatment regimen and/or monitoring is dictated by a protocol

• Previous exposure to an investigational or licensed multi-kinase inhibitor or an anti- VEGF angiogenesis inhibitor for advanced or metastatic disease

• Life expectancy < 12 weeks