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

February 7, 2024 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Sollentuna, Sweden, 19190
        • Pfizer Innovations AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Sutent
Drug: axitinib
As provided in real world
Other Names:
  • Inlyta

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least 1 Filled Sunitinib Prescription
Time Frame: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Number of participants who had at least one filled prescription of sunitinib were analyzed and reported in this outcome measure.
Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Number of Participants With 4:2 Sunitinib Schedule Without Any Modification
Time Frame: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Number of participants that initiated treatment with 4:2 (4 weeks on/2 weeks off) sunitinib schedule and did not have any modification in the schedule were reported in this outcome measure.
Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Number of Participants With 2:1 Sunitinib Schedule Without Any Modification
Time Frame: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Number of participants that initiated treatment with 2:1 (2 weeks on/1 week off) sunitinib schedule and did not have any modification in the schedule were reported in this outcome measure.
Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Switched From 4:2 Sunitinib Schedule to 2:1 Sunitinib Schedule
Time Frame: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Number of sunitinib users that started on a 4:2 (4 weeks on/2 weeks off) schedule and later was switched to a 2:1 (2 weeks on/1 week off) schedule were reported in this outcome measure.
Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Number of Participants on Second Line Treatment With at Least 1 Filled Axitinib Prescription
Time Frame: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Number of participants that had at least one filled prescription of axitinib were reported in this outcome measure.
Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Time to Treatment Discontinuation (TTD)
Time Frame: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
TTD was defined as the difference between the start and end-dates for a treatment episode regardless of reason for discontinuation. The start date for a treatment episode was defined as the date of first dispensed package and the end date was defined as the date of the last dispensed package with the same Anatomical Therapeutic Chemical (ATC) code, plus the number of days that package, as well as accumulated medicine was intended to cover. End date was overruled if there was a new filled prescription of another relevant ATC code or death happens before this, then either of these dates represents the end date. If no end of prescribed supply was recorded, data was censored at latest available date in data.
Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
Overall Survival (OS)
Time Frame: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
OS was defined as the time (number of days) from the start of the treatment (the date of the first dispensed package of Sunitinib or axitinib) until the date of death as documented in the Cause of Death Register. If no death was recorded, data was censored at latest available date in data.
Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6181234
  • RENCOMP3 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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