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

18 Years
Open (Enrolling)
Carcinoma, Renal Cell

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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.

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

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:


Outcome Description:

To evaluate overall survival (OS), progression-free survival (PFS) and the overall response rate (ORR) in patients treated with pazopanib

Outcome Time Frame:

Approximately 30 months

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United Kingdom: Research Ethics Committee

Study ID:




Start Date:

July 2012

Completion Date:

July 2016

Related Keywords:

  • Carcinoma, Renal Cell
  • Carcinoma
  • Carcinoma, Renal Cell



GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteLexington, Kentucky  40536-0098
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteHattiesburg, Mississippi  39401
GSK Investigational SiteOmaha, Nebraska  68131
GSK Investigational SiteHenderson, Nevada  89014