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Trial record 1 of 1 for:    NCT04669366
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Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries

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ClinicalTrials.gov Identifier: NCT04669366
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 9, 2020
First Posted Date December 16, 2020
Last Update Posted Date March 11, 2021
Actual Study Start Date January 20, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2020)
Time to treatment discontinuation in first line sunitinib patients [ Time Frame: July 1st 2005 to September 30th 2020 ]
Time to treatment discontinuation in first line sunitinib patients. Time to event measure with timeframe 0 - 180 months from treatment initiation.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 9, 2020)
  • Overall survival (OS) for first line patients with sunitinib [ Time Frame: July 1st 2005 to September 30th 2020 ]
    Overall survival in first line sunitinib patients. Time to event measure with time frame 0 - 180 months from treatment initiation.
  • Time to treatment discontinuation in second line axitinib patients [ Time Frame: July 1st 2005 to September 30th 2020 ]
    Time to treatment discontinuation in first line sunitinib patients. Time to event measure with timeframe 0 - 180 months from treatment initiation.
  • Overall survival (OS) for second line patients with axitinib [ Time Frame: July 1st 2005 to September 30th 2020 ]
    Overall survival in second line axitinib patients. Time to event measure with time frame 0 - 180 months from treatment initiation.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries
Official Title Treatment Patterns With Targeted Therapies in Metastatic Renal Cell Carcinoma (mRCC) in Sweden - A Retrospective Analysis of Data From National Registries
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Kidney Neoplasms
Intervention
  • Drug: sunitinib
    As provided in real world
    Other Name: Sutent
  • Drug: axitinib
    As provided in real world
    Other Name: Inlyta
Study Groups/Cohorts Patients in Sweden with metastatic renal cell carcinoma
The cohort of patients with metastatic renal cell carcinoma in Sweden
Interventions:
  • Drug: sunitinib
  • Drug: axitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 9, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04669366
Other Study ID Numbers A6181234
RENCOMP3 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2021