Axitinib Therapy Management Study

Renal Cell Carcinoma Clinical Trial

Official title:

Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04555603
• Other study ID #: A4061096
• Status: Withdrawn
• Start date: September 15, 2020
• Est. completion date: February 22, 2021

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

not mandatory

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Inlyta
axitinib
• Bavencio
avelumab
• Keytruda
Pembrolizumab

Locations

Country	Name	City	State
United States	Pfizer Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To describe the percentage of patients with documentation of dose modifications	describe dose modifications	during treatment period
Primary	To describe the percentage of patients with usage of concomitant high-dose corticosteroid	descriptive assessment	during treatment period
Primary	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
Primary	To estimate the best overall response (partial response, complete response, progressive disease, or stable disease	description of overall response	during treatment period
Primary	To estimate time to treatment discontinuation	calculation of duration of treatment	during treatment period
Primary	To estimate PFS	calculation of progression free survival	during treatment period

External Links

•   To obtain contact information for a study center near you, click here.