Trial Information

PRINCIPAL: A Prospective Observational Study of Real World Treatment Patterns and Treatment Outcomes in Patients With Advanced or Metastatic Renal Cell Carcinoma Receiving Pazopanib

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. Sites will
be contacted and qualified by the estimated number of advanced or metastatic RCC patients
available for enrollment annually. To the extent possible, consecutive patients meeting
inclusion/exclusion criteria will be enrolled. Sites will be required to maintain a patient
enrolment log of eligible patients at their treatment centres. This log will document how
patients came to be included or excluded from the study, in order to assess the
representativeness of the study population. The overall number of patients and sites may be
adjusted during the study to meet enrollment goals, if needed. Eligible patients will be
enrolled by medical oncologists and potentially by urologists experienced in the management
of patients with RCC, if consistent with local practice. 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). Follow-up information will be collected
approximately every 3 months (a window of ± 4 weeks around the date of the suggested data
collection will be allowed). If the patient is not seen for a regularly scheduled visit at
that time, the site may contact the patient by telephone to solicit information regarding
the events of interest and to limit loss to follow up. It is anticipated that frequency of
patient assessment and imaging will differ according to local standard practice; therefore
the quarterly data collection time points are intended to collect all assessments (with the
date of assessment) since the previous visit date.