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Trial record 1 of 1 for:    NCT04555603
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Axitinib Therapy Management Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04555603
Recruitment Status : Active, not recruiting
First Posted : September 18, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 14, 2020
First Posted Date September 18, 2020
Last Update Posted Date December 21, 2020
Actual Study Start Date September 15, 2020
Estimated Primary Completion Date December 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2020)
  • 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
Original Primary Outcome Measures
 (submitted: September 14, 2020)
  • 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 progression-free survival (PFS) [ Time Frame: during treatment period ]
    calculation of progression free survival
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Axitinib Therapy Management Study
Official Title Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
Brief Summary The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population academic and community centers
Condition Renal Cell Carcinoma
Intervention
  • Drug: Inlyta
    axitinib
    Other Name: Axitinib as prescribed in the real world
  • Drug: Bavencio
    avelumab
    Other Name: Avelumab as prescribed in the real world
  • Drug: Keytruda
    Pembrolizumab
    Other Name: Pembrolizumab as prescribed in the real world
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 14, 2020)		 1
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04555603
Other Study ID Numbers A4061096
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2020