A Study to evaluate the effectiveness and safety of Pazopanib in a real world scenario in patients with advanced stage of renal cell carcinoma.
- Conditions
- Health Condition 1: null- patients with advanced or metastatic RCCof any histology who are treated according to local practices and treated for the first time withpazopanib
- Registration Number
- CTRI/2017/04/008347
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1-Documented diagnosis of advanced or metastatic RCC of any histology and treated
according to local practice and treated with pazopanib.
2-Clinical decision made to initiate new treatment with pazopanib or at least 15 days prior to
enrollment in the study.
3-Patients naïve to any prior anti-VEGF therapy (prior immunotherapy including cytokines
are allowed).
4-Patients who provide written informed consent according to local guidelines.
-Note: Patients will be allowed to participate in other interventional clinical studies
5-Before starting pazopanib therapy (except trials involving VEGF-TKI treatments
where the patient is randomized/included into the VEGF-TKI arm).
6-During the course of the study as long as the therapy is not a VEGF-TKI.
1-Prior treatment with VEGF-TKI before starting pazopanib therapy
2-Life expectancy < 12 weeks based on the Treating Physicianâ??s assessment.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the clinical effectiveness of pazopanib in the real-life setting in patients naïve <br/ ><br>to VEGF-TKI therapy based on the proportion of patients remaining progression free at <br/ ><br>12 months.Timepoint: To describe the clinical effectiveness of pazopanib in the real-life setting in patients naïve <br/ ><br>to VEGF-TKI therapy based on the proportion of patients remaining progression free at <br/ ><br>12 months.
- Secondary Outcome Measures
Name Time Method To describe other clinical effectiveness factors for pazopanib. <br/ ><br>Overall response rate (ORR) at 12 months. <br/ ><br>Progression-free survival (PFS) at end of study (EOS). Overall survival (OS) at EOS. <br/ ><br>Response (ORR and progression-free (PF) response) according to Memorial Sloan- <br/ ><br>Kettering Cancer Center (MSKCC)/Heng criteria and age category. <br/ ><br>To assess the safety and tolerability of pazopanib at 12 months. <br/ ><br>Timepoint: Outcomes will be assessed at 3 months, 9 months, 12 months and at the end of the study around 30 months