Renal Cell CarcinomaNCT04555603
Axitinib Therapy Management Study
An observational study of Renal Cell Carcinoma, run by Pfizer at 1 site in United States.
Trial summary
The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Inlyta, Bavencio and Keytruda
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 22 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: academic and community centers
Who may be able to join
- Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point
- Age 18 years or older at the time of aRCC diagnosis
- Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI
Read the detailed description
not mandatory
- Conditions
- Renal Cell Carcinoma
- Being tested
- Inlyta, Bavencio, Keytruda
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InlytaDrug
Also called Axitinib as prescribed in the real world
axitinib
BavencioDrug
Also called Avelumab as prescribed in the real world
avelumab
KeytrudaDrug
Also called Pembrolizumab as prescribed in the real world
Pembrolizumab
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe type of immune related adverse events and adverse events related to axitinib
describe type of immune related adverse events and adverse events related to axitinib
Measured: during treatment period
To describe the percentage of patients with documentation of dose modifications
describe dose modifications
Measured: during treatment period
To describe the percentage of patients with usage of concomitant high-dose corticosteroid
descriptive assessment
Measured: during treatment period
To describe the percentage of patients alive at pre-specified time points (6 months, 12 months, 18 months, 24 months) from start of the index therapy
calculation of overall survival time
Measured: during study period
To estimate the best overall response (partial response, complete response, progressive disease, or stable disease
description of overall response
Measured: during treatment period
To estimate time to treatment discontinuation
calculation of duration of treatment
Measured: during treatment period
To estimate PFS
calculation of progression free survival
Measured: during treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start15 Sep 2020
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Why it stopped: Failed at data quality assurance process before any analyses would be performed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555603
- Sponsor's protocol ID
- A4061096
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
- ClinicalTrials.gov ID
- NCT04555603
- Acronym / sponsor ID
- A4061096
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Failed at data quality assurance process before any analyses would be performed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
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 the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI
Detailed description
not mandatory
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- academic and community centers
Key inclusion criteria (3 listed)
- Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point
- Age 18 years or older at the time of aRCC diagnosis
- Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| InlytaAlso: Axitinib as prescribed in the real worldaxitinib | Drug | – |
| BavencioAlso: Avelumab as prescribed in the real worldavelumab | Drug | – |
| KeytrudaAlso: Pembrolizumab as prescribed in the real worldPembrolizumab | Drug | – |
Primary outcome
To describe type of immune related adverse events and adverse events related to axitinib
Time frame: during treatment period
describe type of immune related adverse events and adverse events related to axitinib
To describe the percentage of patients with documentation of dose modifications
Time frame: during treatment period
describe dose modifications
To describe the percentage of patients with usage of concomitant high-dose corticosteroid
Time frame: during treatment period
descriptive assessment
To describe the percentage of patients alive at pre-specified time points (6 months, 12 months, 18 months, 24 months) from start of the index therapy
Time frame: during study period
calculation of overall survival time
To estimate the best overall response (partial response, complete response, progressive disease, or stable disease
Time frame: during treatment period
description of overall response
To estimate time to treatment discontinuation
Time frame: during treatment period
calculation of duration of treatment
To estimate PFS
Time frame: during treatment period
calculation of progression free survival
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- 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 Renal Cell Carcinoma, run by Pfizer at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 21 Nov 2023. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To describe type of immune related adverse events and adverse events related to axitinib (time frame: during treatment period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.