A study to observe the effects of treating patients with pazopanib in the real world setting.
- Conditions
- advanced or metastatic Renal Cell CarcinomaMedDRA version: 19.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-003065-15-FI
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
Specific information regarding warnings, precautions, contraindications, adverse events,
and other pertinent information regarding pazopanib that may impact patient treatment is
found in the local product labeling.
Deviations from inclusion criteria are not allowed because they can potentially jeopardize
the scientific integrity of the study. Therefore, adherence to the criteria as specified in the
protocol is essential.
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
Deviations from exclusion criteria are not allowed because they can potentially
jeopardize the scientific integrity of the study. Therefore, adherence to the criteria as
specified in the protocol is essential.
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 (for guidance, refer
to Appendix 1 located in the protocol).
• Life expectancy < 12 weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method