To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma

A Panel-Based Chart Review Study to Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving First-Line Axitinib in Combination With Immune-Oncology Drugs for the Treatment of Advanced Renal Cell Carcinoma

To assess how dose reductions or treatment interruptions related to axitinib can be implemented to manage and resolve adverse events occurring among patients with advanced renal cell carcinoma treated with first-line axitinib in combination with avelumab or pembrolizumab

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Drug: Axitinib; Drug: Avelumab; Drug: Pembrolizumab

Detailed Description

The specific objectives of the study are as follows:

Describe incident adverse events (AEs) experienced among patients with advanced RCC who received first-line axitinib in combination with immuno-oncology (IO) therapies.

• Type and seriousness of AEs (ie, diarrhea, fatigue, hypertension, nausea, palmar plantar erythrodysesthesia [hand-foot syndrome]).
• Proportion of patients who experienced repeated AEs.
• Time from treatment initiation to AE onset, overall and by type and seriousness of AEs.

Among patients with advanced RCC who developed incident AEs while receiving first line axitinib in combination with IO therapies, characterize and describe management strategies for AEs, stratified by type and seriousness of AEs.

• Proportion of patients who used each of the following management strategies:
• No action for axitinib and IO therapy;
• No action for axitinib, but treatment modification for IO therapy (ie, treatment interruption, treatment discontinuation);
• Axitinib dose reduction, but no action for IO therapy;
• Axitinib treatment interruption, but no action for IO therapy;
• Axitinib treatment discontinuation, but no action for IO therapy;
• Axitinib dose reduction, and treatment modification for IO therapy;
• Axitinib treatment interruption, and treatment modification for IO therapy;
• Axitinib treatment discontinuation, and treatment modification for IO therapy.
• Average axitinib dose reduction (absolute and percentage change), where applicable.
• Duration of treatment interruption, where applicable.

Assess the frequency of and time to AE resolution (from AE onset and initiation of management strategy, separately) among patients with advanced RCC who developed incident AEs while receiving first-line axitinib in combination with IO therapies according to different management strategies implemented, stratified further by type and seriousness of AEs, as allowed by sample size.

The above objectives will also be conducted for repeated AEs of the same type

• Study Type: Observational
• Enrollment (Actual): 481

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with aRCC

Description

Inclusion Criteria:

Physicians meeting the following criteria will be invited to participate in the chart review study:

• Specialty in oncology
• Access to complete medical records for at least one patient with advanced RCC who meets the patient eligibility criteria

Eligible oncologists will be asked to select up to three patients meeting the following criteria for inclusion in the chart review study:

• Confirmed diagnosis with advanced RCC
• Treated with first-line axitinib/IO combination therapy at or after diagnosis
• Experienced at least one AE (i.e., diarrhea, fatigue, nausea, hypertension, and palmar-plantar erythrodysesthesia [hand-foot syndrome]) while treated with axitinib/IO combination therapy
• Age 18 years or older at the time of advanced RCC diagnosis
• Initiated axitinib/IO combination therapy at least 3 months prior to the start date of medical chart abstraction to ensure sufficient follow-up time

Exclusion Criteria:

There are no exclusion criteria for this study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe incident Adverse Events (AEs) experienced among patients with advanced RCC who received first-line axitinib in combination with immune-oncology IO therapies	Descriptive analyses of incident AEs	During the intervention
Characterize and describe management strategies for AEs , stratified by type and seriousness of AEs	Descriptive analyses of management strategies to resolve AEs	During the intervention
Assess the frequency of and time to AE resolution (from AE onset and initiation of management strategy, separately)	Time to AEs resolution	During axitinib treatment period

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 24, 2021
• Primary Completion (ACTUAL): April 5, 2021
• Study Completion (ACTUAL): April 5, 2021

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (ACTUAL): December 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Advanced Renal Cell Carcinoma (aRCC)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Pembrolizumab; Avelumab; Axitinib
• Other Study ID Numbers: A4061097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No