Kidney NeoplasmsNCT04669366

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

An observational study of Kidney Neoplasms, run by Pfizer at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Kidney Neoplasms
What is being tested?: sunitinib and axitinib
How many people: 1,205 participants
Where: 1 siteSweden
Study dates: 20 Jan 2021to 18 Mar 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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).
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.

Who cannot join

Patients with ICD-7 code I801 will be excluded

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Pfizer Innovations AB
Sollentuna, 19190

Other trials in Sweden

About this study

Official title: 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.

Conditions: Kidney Neoplasms
Being tested: sunitinib, axitinib
Medical subject headings: Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sunitinibDrug
Also called Sutent
As provided in real world
axitinibDrug
Also called Inlyta
As provided in real world

Study groups in NCT04669366
Study group	Role	What they receive
Patients in Sweden with metastatic renal cell carcinoma		The cohort of patients with metastatic renal cell carcinoma in Sweden Receives: Drug: sunitinib; Drug: axitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With at Least 1 Filled Sunitinib Prescription
Number of participants who had at least one filled prescription of sunitinib were analyzed and reported in this outcome measure.
Measured: 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
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.
Measured: 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
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.
Measured: 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 outcomes (4)

Number of Participants Switched From 4:2 Sunitinib Schedule to 2:1 Sunitinib Schedule
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.
Measured: 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
Number of participants that had at least one filled prescription of axitinib were reported in this outcome measure.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 202118 Mar 2022

First posted16 Dec 2020
Study start20 Jan 2021
Primary completion31 Jul 2021
Study completion18 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 1,205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04669366
Sponsor's protocol ID: A6181234
Other IDs: RENCOMP3
Status last verified: Jun 2023
First submitted: 9 Dec 2020
Last updated: 19 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: 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.

Publications

Jakobsson M, Strambi A, Nilsson F, Arpegard J, Dalen J. Real-world experience of second-line axitinib in metastatic renal cell carcinoma: analysis of the Swedish population. Future Oncol. 2024;20(20):1385-1392. doi: 10.1080/14796694.2024.2351352. Epub 2024 Jul 26.
PubMed 39057291

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Kidney Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Patterns With Targeted Therapies in Metastatic Renal Cell Carcinoma (mRCC) in Sweden - A Retrospective Analysis of Data From National Registries
ClinicalTrials.gov ID: NCT04669366
Acronym / sponsor ID: A6181234
Conditions: Kidney Neoplasms
Study type: Observational
Recruitment status: Completed
Enrolment: 1,205 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 20 Jan 2021 (actual)
Primary completion: 31 Jul 2021 (actual)
Study completion: 18 Mar 2022 (actual)
First posted: 16 Dec 2020 (actual)
Results: Posted 19 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients in Sweden with metastatic renal cell carcinoma	–	Drug: sunitinib, Drug: axitinibThe cohort of patients with metastatic renal cell carcinoma in Sweden

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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).
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.

Key exclusion criteria (1 listed)

Patients with ICD-7 code I801 will be excluded

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sunitinibAlso: SutentAs provided in real world	Drug	Patients in Sweden with metastatic renal cell carcinoma
axitinibAlso: InlytaAs provided in real world	Drug	Patients in Sweden with metastatic renal cell carcinoma

Primary outcome

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.
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.
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.

4 secondary outcomes

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 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
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
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

Results and safety

Results posted to the registry on 19 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sunitinib 4:2 Schedule	704	704
Sunitinib 2:1 Schedule	320	320
Sunitinib: Switched From 4:2 to 2:1 Schedule	71	71
Axitinib	110	110

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Sunitinib 4:2 Schedule n = 704	Sunitinib 2:1 Schedule n = 320	Sunitinib: Switched From 4:2 to 2:1 Schedule n = 71	Axitinib n = 110
Value	704	320	71	53

Population analysed: Analysis population included all eligible participants whose data were retrieved from national registries and assessed.

Primary outcome: Number of Participants With 4:2 Sunitinib Schedule Without Any Modification

Measure	Sunitinib 4:2 Schedule n = 704
Value	704

Population analysed: Analysis population included all eligible participants whose data were retrieved from national registries and assessed. This outcome measure was planned to be analyzed only for Sunitinib 4:2 Schedule reporting group.

Primary outcome: Number of Participants With 2:1 Sunitinib Schedule Without Any Modification

Measure	Sunitinib 2:1 Schedule n = 320
Value	320

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: 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. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sunitinib 4:2 Schedule	0 of 0	0 of 0	627 of 704
Sunitinib 2:1 Schedule	0 of 0	0 of 0	168 of 320
Sunitinib: Switched From 4:2 to 2:1 Schedule	0 of 0	0 of 0	53 of 71
Axitinib	0 of 0	0 of 0	82 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39057291Jakobsson M, Strambi A, Nilsson F, Arpegard J, Dalen J. Real-world experience of second-line axitinib in metastatic renal cell carcinoma: analysis of the Swedish population. Future Oncol. 2024;20(20):1385-1392. doi: 10.1080/14796694.2024.2351352. Epub 2024 Jul 26.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Neoplasms, run by Pfizer at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04669366, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.