Study Stopped
Failed at data quality assurance process before any analyses would be performed
Axitinib Therapy Management Study
Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
1 other identifier
observational
N/A
1 country
1
Brief Summary
The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2020
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2021
CompletedNovember 21, 2023
November 1, 2023
5 months
September 14, 2020
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (7)
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
during treatment period
To describe the percentage of patients with documentation of dose modifications
describe dose modifications
during treatment period
To describe the percentage of patients with usage of concomitant high-dose corticosteroid
descriptive assessment
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
during study period
To estimate the best overall response (partial response, complete response, progressive disease, or stable disease
description of overall response
during treatment period
To estimate time to treatment discontinuation
calculation of duration of treatment
during treatment period
To estimate PFS
calculation of progression free survival
during treatment period
Interventions
Eligibility Criteria
academic and community centers
You may qualify if:
- 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
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Inc.
New York, New York, 10017, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2020
First Posted
September 18, 2020
Study Start
September 15, 2020
Primary Completion
February 22, 2021
Study Completion
February 22, 2021
Last Updated
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
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.