NCT03538717

"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"

Retrospective Analysis of Clinical Factors Associated With Greater Benefit of Axitinib in Metastatic Renal Cancer (AXILONG Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 157 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Retrospective study to collect data from Patients with advanced/metastatic renal cell carcinoma previously treated with Axitinib under standard clinical practice, to describe the clinical profile of the patients with a long response to Axitinib and to try to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients

Detailed description

To describe the clinical profile of patients with a long response to Axitinib and to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients. For this study are defined as "long responder", those patients who has a Progression Free Survival (PFS) of at least 9 months since the initiation of Axitinib treatment, and "refractory patients" those who have Progression Disease (PD) in the first response assessment since the initiation of Axitinib treatment (estimated PFS ≤3 months\] Secondary Objectives * To describe the efficacy of Axitinib treatment in the long responders group, and in relation with the treatment received before Axitinib, in terms of PFS, ORR, CB, OS, TTP ... * To describe the tolerability and drug management of Axitinib in this population. * To describe treatment received after Axitinib in this population. Study procedures: For the recruitment, the Investigator should review the inclusion / exclusion criteria. In case of patients alive at the moment of the inclusion, the investigator will require them to sign the IC. With the data available in the medical records, the information requested will be recorded in the electronic data collection tool.

Conditions

• Carcinoma, Renal Cell

Timeline

• Start date: 2018-04-19
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2018-05-29
• Last updated: 2022-02-17
• Results posted: 2020-03-13

Locations

40 sites across 1 country: Spain