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A Study to evaluate the effectiveness and safety of Pazopanib in a real world scenario in patients with advanced stage of renal cell carcinoma.

Phase 4
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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
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