Axitinib Therapy Management Study

NCT04555603

Last updated date
Study Location
Pfizer Inc.
New York, New York, 10017, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed diagnosis of advanced renal cell carcinoma (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 immunooncology-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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- none

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
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 Not yet 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 advanced renal cell carcinoma (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 immunooncology-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 to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020