Renal Cell CarcinomaNCT02533258
Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
An observational study of Renal Cell Carcinoma, run by Pfizer.
Trial summary
This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 2 Dec 2015to 12 May 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: advanced renal cell carinoma with disease progression on sunitinib or interferon
Who may be able to join
- Patients diagnosed as advanced RCC by histology or cytology
- Patients using axitinib as therapy after failure of sunitinib or cytokine
- Patients received axitinib treatment and follow up in the health care center participating present registry
- Patients agree to participate and signed inform consent or IRB waiving of signed informed consent document is available
Who cannot join
- Patients with first dose of axitinib earlier than 7th May 2013
- Patients with first dose of axitinib later than 30th June 2015.
- Patients participating in clinical research involving axitinib
- Patients with hypersensitivity to axitinib or to any other component of axitinib
- Patients under 18-year of age
- Pregnant women.
About this study
Official title: POST-MARKETING SURVEILLANCE STUDY TO OBSERVE INLYTA (REGISTERED) TREATMENT DOSING PATTERN, SAFETY AND EFFECTIVENESS IN TAIWAN REAL WORLD ROUTINE PRACTICE
This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.
Read the detailed description
This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary objective is the dose adjustment. Secondary objectives are safety profile, objective response rate and progression free survival. Efficacy assessment will be based on investigators' judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015 will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib or interferon alpha.
- Conditions
- Renal Cell Carcinoma
- Keywords
- advanced renal cell carcinoma, disease progression, sunitinib, interferon alpha
- Medical subject headings
- Carcinoma, Renal Cell, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Axitinib Treatment
Measured: From initiation of axitinib treatment up to the end of the study (up to 40 months)
Mean Daily Dose of Axitinib
Measured: From initiation of axitinib treatment up to the end of the study (up to 40 months)
Secondary outcomes (7)
Objective Response Rate (ORR)
ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than [<]10 millimeter [mm] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment.
Measured: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Duration of Response
Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (<10 mm short axis). PR was defined as at least 30% decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. PD was defined as >=20% increase in sum of diameters of the target lesions taking as a reference smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions.
Measured: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Progression-Free Survival (PFS)
PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as >=20% increase in the sum of the diameters of the target lesions taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated.
Measured: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non--serious events.
Measured: From initiation of axitinib treatment up to end of the study (up to 40 months)
Number of Participants With Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.
Measured: From initiation of axitinib treatment up to end of the study (up to 40 months)
Number of Participants With Treatment-Related Adverse Events (AEs)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Measured: From initiation of axitinib treatment up to end of the study (up to 40 months)
Number of Participants Discontinued Due to Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: From initiation of axitinib treatment up to end of the study (up to 40 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study start2 Dec 2015
- Primary completion12 May 2016
- Study completion12 May 2016
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.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 13 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
- NCT02533258
- Sponsor's protocol ID
- A4061076
- Other IDs
- NCT02533258
- Status last verified
- Jul 2025
- First submitted
- 24 Aug 2015
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POST-MARKETING SURVEILLANCE STUDY TO OBSERVE INLYTA (REGISTERED) TREATMENT DOSING PATTERN, SAFETY AND EFFECTIVENESS IN TAIWAN REAL WORLD ROUTINE PRACTICE
- ClinicalTrials.gov ID
- NCT02533258
- Acronym / sponsor ID
- A4061076
- Conditions
- Renal Cell Carcinoma
- Keywords
- advanced renal cell carcinoma, disease progression, sunitinib, interferon alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 12 May 2016 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Posted 5 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.
Detailed description
This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary objective is the dose adjustment. Secondary objectives are safety profile, objective response rate and progression free survival. Efficacy assessment will be based on investigators' judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015 will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib or interferon alpha.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced renal cell carinoma with disease progression on sunitinib or interferon
Key inclusion criteria (4 listed)
- Patients diagnosed as advanced RCC by histology or cytology
- Patients using axitinib as therapy after failure of sunitinib or cytokine
- Patients received axitinib treatment and follow up in the health care center participating present registry
- Patients agree to participate and signed inform consent or IRB waiving of signed informed consent document is available
Key exclusion criteria (6 listed)
- Patients with first dose of axitinib earlier than 7th May 2013
- Patients with first dose of axitinib later than 30th June 2015.
- Patients participating in clinical research involving axitinib
- Patients with hypersensitivity to axitinib or to any other component of axitinib
- Patients under 18-year of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of Axitinib Treatment
Time frame: From initiation of axitinib treatment up to the end of the study (up to 40 months)
Mean Daily Dose of Axitinib
Time frame: From initiation of axitinib treatment up to the end of the study (up to 40 months)
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Duration of Response
Time frame: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Progression-Free Survival (PFS)
Time frame: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From initiation of axitinib treatment up to end of the study (up to 40 months)
Number of Participants With Adverse Events (AEs) by Severity
Time frame: From initiation of axitinib treatment up to end of the study (up to 40 months)
Number of Participants With Treatment-Related Adverse Events (AEs)
Time frame: From initiation of axitinib treatment up to end of the study (up to 40 months)
Number of Participants Discontinued Due to Adverse Events (AEs)
Time frame: From initiation of axitinib treatment up to end of the study (up to 40 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Pfizer.
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 4 inclusion and 6 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 5 Oct 2017). 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?
Duration of Axitinib Treatment (time frame: From initiation of axitinib treatment up to the end of the study (up to 40 months)). The study lists 2 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 16 Jul 2025.