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NCT04669366 Clinical Trial

Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries

Kidney Neoplasms Clinical Trial

Official title:
Treatment Patterns With Targeted Therapies in Metastatic Renal Cell Carcinoma (mRCC) in Sweden - A Retrospective Analysis of Data From National Registries

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04669366
Other study ID # A6181234
Secondary ID RENCOMP3
Status Completed
Phase
First received
Last updated
Start date January 20, 2021
Est. completion date July 31, 2021

Study information
Verified date September 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objectives of this study is to investigate treatment patterns and outcomes for Sutent and Inlyta in mRCC patients in a nationwide population-based setting in Sweden.

Recruitment information / eligibility
Status Completed
Enrollment 1095
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: 1. all patients aged = 18 years with at least one filled prescription of an oral targeted therapy relevant for treating mRCC registered in the Swedish Prescribed Drug Register (PDR) between July 1st 2005 and June 30th 2020. The Anatomical Therapeutic Chemical (ATC) codes for the oral drugs relevant for treating mRCC are the following: L01XE04 (sunitinib), L01XE05 (sorafenib), L01XE11 (pazopanib), L01XE17 (axitinib), L01XE10 (everolimus), L01XE26 (cabozantinib), L01XE34 (tivozantib), L01XE29 (lenvatinib). 2. The patients identified in the PDR that also are identified in the SCR with the International Classification of Diseases and Related Health Problems (ICD)-7 diagnosis codes I800 or I809 and ICD-10 codes C64.0 and C64.9 from January 1st 2000 until December 31st 2019;excluding ICD-7 code I801 (cancer of the renal pelvis) will be included in the analysis set. Exclusion Criteria: Patients with ICD-7 code I801 will be excluded

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• sunitinib
As provided in real world
• axitinib
As provided in real world

Locations
Country Name City State
Sweden Pfizer Innovations AB Sollentuna

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to treatment discontinuation in first line sunitinib patients Time to treatment discontinuation in first line sunitinib patients. Time to event measure with timeframe 0 - 180 months from treatment initiation. July 1st 2005 to December 31th 2019
Secondary Overall survival (OS) for first line patients with sunitinib Overall survival in first line sunitinib patients. Time to event measure with time frame 0 - 180 months from treatment initiation. July 1st 2005 to December 31th 2019
Secondary Time to treatment discontinuation in second line axitinib patients Time to treatment discontinuation in first line sunitinib patients. Time to event measure with timeframe 0 - 180 months from treatment initiation. July 1st 2005 to December 31th 2019
Secondary Overall survival (OS) for second line patients with axitinib Overall survival in second line axitinib patients. Time to event measure with time frame 0 - 180 months from treatment initiation. July 1st 2005 to December 31th 2019
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