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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682587
• Other study ID #: A4061097
• Status: Completed
• Start date: February 24, 2021
• Est. completion date: April 5, 2021

Study information

• Verified date: September 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Axitinib
Inlyta, axitinib
• Avelumab
Avelumab, Bavencio
• Pembrolizumab
Pembrolizumab, Keytruda

Locations

Country	Name	City	State
United States	Pfizer	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	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
Primary	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
Primary	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

External Links

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