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

Completed

Conditions studied: Carcinoma, Renal Cell

In brief

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).

Key facts

Study ID

NCT01649778

Run by

Novartis Pharmaceuticals

People needed

662

Starts

2012-07-19

Expected to finish

2017-07-03

Last updated by the study team

2020-07-15

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Orange, California, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Shreveport, Louisiana, United States
• Novartis Investigative Site — Jackson, Mississippi, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Henderson, Nevada, United States
• Novartis Investigative Site — The Bronx, New York, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Sioux Falls, South Dakota, United States
• Novartis Investigative Site — Austin, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Fort Worth, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Berazategui, Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
• Novartis Investigative Site — Córdoba, Argentina
• Novartis Investigative Site — San Miguel de Tucumán, Argentina
• Novartis Investigative Site — Santa Fe, Argentina
• Novartis Investigative Site — Hall in Tirol, Austria
• Novartis Investigative Site — Innsbruck, Austria
• Novartis Investigative Site — Leoben, Austria
• Novartis Investigative Site — Linz, Austria
• Novartis Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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