NCT02184416

Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting

AXITINIB IN ADVANCED / METASTATIC RENAL CELL CARCINOMA - A NON-INTERVENTIONAL STUDY OF REAL WORLD TREATMENT OUTCOMES IN PATIENTS RECEIVING 2ND LINE AXITINIB AFTER 1ST LINE SUNITINIB (ADONIS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 554 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.

Detailed description

Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. The possible sequences of treatment under investigation will be: * Sutent (prospective) - Inlyta * Sutent (retrospective) - Inlyta * Sutent - not further active treatment (supportive care) * Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus), other)) The study will enroll approximately 750 adv/mRCC patients at the 1st and 2nd line treatment level. Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. Therefore for some patients there will be a retrospective Sutent data collection. The primary endpoints of this study in patients with adv/mRCC are PFS and TTF for patients receiving Inlyta in 2nd line, and the combined PFS and TTF for patients receiving the Sutent-Inlyta sequence. In this non-interventional real life study, the objective is only descriptive and the sample size will rely on the precision of the estimate.

Conditions

• Metastatic Renal Cell Carcinoma (mRCC)

Interventions

Type	Name	Description
OTHER	observational	The study is non interventional. All drugs will be prescribed

Timeline

• Start date: 2014-10-31
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2014-07-09
• Last updated: 2026-02-27

Locations

110 sites across 8 countries: Austria, Belgium, France, Greece, Italy, Netherlands, Spain, United Kingdom