Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04669366
Recruitment Status : Completed
First Posted : December 16, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment
Kidney Neoplasms Drug: sunitinib Drug: axitinib

Layout table for study information
Study Type : Observational
Actual Enrollment : 1095 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns With Targeted Therapies in Metastatic Renal Cell Carcinoma (mRCC) in Sweden - A Retrospective Analysis of Data From National Registries
Actual Study Start Date : January 20, 2021
Actual Primary Completion Date : July 31, 2021
Actual Study Completion Date : July 31, 2021


Group/Cohort Intervention/treatment
Patients in Sweden with metastatic renal cell carcinoma
The cohort of patients with metastatic renal cell carcinoma in Sweden
Drug: sunitinib
As provided in real world
Other Name: Sutent

Drug: axitinib
As provided in real world
Other Name: Inlyta




Primary Outcome Measures :
  1. Time to treatment discontinuation in first line sunitinib patients [ Time Frame: July 1st 2005 to December 31th 2019 ]
    Time to treatment discontinuation in first line sunitinib patients. Time to event measure with timeframe 0 - 180 months from treatment initiation.


Secondary Outcome Measures :
  1. Overall survival (OS) for first line patients with sunitinib [ Time Frame: July 1st 2005 to December 31th 2019 ]
    Overall survival in first line sunitinib patients. Time to event measure with time frame 0 - 180 months from treatment initiation.

  2. Time to treatment discontinuation in second line axitinib patients [ Time Frame: July 1st 2005 to December 31th 2019 ]
    Time to treatment discontinuation in first line sunitinib patients. Time to event measure with timeframe 0 - 180 months from treatment initiation.

  3. Overall survival (OS) for second line patients with axitinib [ Time Frame: July 1st 2005 to December 31th 2019 ]
    Overall survival in second line axitinib patients. Time to event measure with time frame 0 - 180 months from treatment initiation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The data used for the analyses includes 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 between July 1st 2005 (there is no data available in the register before this date) 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). 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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669366


Locations
Layout table for location information
Sweden
Pfizer Innovations AB
Sollentuna, Sweden, 19190
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04669366    
Other Study ID Numbers: A6181234
RENCOMP3 ( Other Identifier: Alias Study Number )
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Sunitinib
Axitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action