Axitinib Therapy Management Study

Withdrawn

• Conditions: Renal Cell Carcinoma

• Registration Number: NCT04555603
• Lead Sponsor: Pfizer

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 mandatory

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study Start: 2020-09-15
• Study First Posted: 2020-09-18
• Primary Completion: 2021-02-22
• Study Completion: 2021-02-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate time to treatment discontinuation	during treatment period	calculation of duration of treatment
To estimate the best overall response (partial response, complete response, progressive disease, or stable disease	during treatment period	description of overall response
To describe the percentage of patients with documentation of dose modifications	during treatment period	describe dose modifications
To describe the percentage of patients with usage of concomitant high-dose corticosteroid	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	during study period	calculation of overall survival time
To estimate PFS	during treatment period	calculation of progression free survival
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

Trial Locations

Locations (1)

Pfizer Inc.; 🇺🇸 New York, New York, United States