Axitinib Therapy Management Study

Sponsor
Pfizer (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04555603
Collaborator
(none)
0
1
5.3
0

Study Details

Study Description

Brief Summary

The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI

Condition or Disease Intervention/Treatment Phase

Detailed Description

not mandatory

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
Actual Study Start Date :
Sep 15, 2020
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Feb 22, 2021

Outcome Measures

Primary Outcome Measures

  1. To describe type of immune related adverse events and adverse events related to axitinib [during treatment period]

    describe type of immune related adverse events and adverse events related to axitinib

  2. To describe the percentage of patients with documentation of dose modifications [during treatment period]

    describe dose modifications

  3. To describe the percentage of patients with usage of concomitant high-dose corticosteroid [during treatment period]

    descriptive assessment

  4. 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 [during study period]

    calculation of overall survival time

  5. To estimate the best overall response (partial response, complete response, progressive disease, or stable disease [during treatment period]

    description of overall response

  6. To estimate time to treatment discontinuation [during treatment period]

    calculation of duration of treatment

  7. To estimate PFS [during treatment period]

    calculation of progression free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Inc. New York New York United States 10017

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04555603
Other Study ID Numbers:
  • A4061096
First Posted:
Sep 18, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022