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

PAzopanib Real-world Assessment of Clinical effectiveness and safety in patients wHo have Undergone Treatment in different sEttings in advanced renal cell carcinoma; a prospective, non-interventional, observational study - PARACHUTE

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/04/008347

Enrollment

250

Registered

2017-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- patients with advanced or metastatic RCC of any histology who are treated according to local practices and treated for the first time with pazopanib

Interventions

None listed

Eligibility

Inclusion criteria

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 naÃ¯ve 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

Exclusion criteria: 1-Prior treatment with VEGF-TKI before starting pazopanib therapy 2-Life expectancy < 12 weeks based on the Treating Physicianâ??s assessment.

Design outcomes

Primary

Measure	Time frame
To describe the clinical effectiveness of pazopanib in the real-life setting in patients naÃ¯ve to VEGF-TKI therapy based on the proportion of patients remaining progression free at 12 months.Timepoint: To describe the clinical effectiveness of pazopanib in the real-life setting in patients naÃ¯ve to VEGF-TKI therapy based on the proportion of patients remaining progression free at 12 months.	—

Secondary

Measure	Time frame
To describe other clinical effectiveness factors for pazopanib. Overall response rate (ORR) at 12 months. Progression-free survival (PFS) at end of study (EOS). Overall survival (OS) at EOS. Response (ORR and progression-free (PF) response) according to Memorial Sloan- Kettering Cancer Center (MSKCC)/Heng criteria and age category. To assess the safety and tolerability of pazopanib at 12 months. Timepoint: Outcomes will be assessed at 3 months, 9 months, 12 months and at the end of the study around 30 months	—

Measure

Time frame

To describe other clinical effectiveness factors for pazopanib. Overall response rate (ORR) at 12 months. Progression-free survival (PFS) at end of study (EOS). Overall survival (OS) at EOS. Response (ORR and progression-free (PF) response) according to Memorial Sloan- Kettering Cancer Center (MSKCC)/Heng criteria and age category. To assess the safety and tolerability of pazopanib at 12 months. Timepoint: Outcomes will be assessed at 3 months, 9 months, 12 months and at the end of the study around 30 months

—

Countries

Algeria, Egypt, Hong Kong, India, Lebanon, Malaysia, Singapore, Taiwan, Viet Nam

Contacts

Public ContactDr Manish Mistry

Novartis India Limited

manish.mistry@novartis.com9820053069

Outcome results