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

NCT ID: NCT04682587

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 481 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-24
• Study Completion Date: 2021-04-05

Brief 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

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

Conditions

Renal Cell Carcinoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Axitinib

Inlyta, axitinib

Intervention Type: DRUG

Avelumab

Avelumab, Bavencio

Intervention Type: DRUG

Pembrolizumab

Pembrolizumab, Keytruda

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer

New York, New York, United States

Countries

United States

References

Zakharia Y, Huynh L, Du S, Chang R, Pi S, Sundaresan S, Duh MS, Zanotti G, Thomaidou D. Impact of Therapy Management on Axitinib-Related Adverse Events in Patients With Advanced Renal Cell Carcinoma Receiving First-Line Axitinib + Checkpoint Inhibitor. Clin Genitourin Cancer. 2023 Oct;21(5):e343-e351. doi: 10.1016/j.clgc.2023.03.017. Epub 2023 Apr 3.

Reference Type: DERIVED

PMID: 37087399 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=A4061097

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Other Identifiers

A4061097

Identifier Type: -

Identifier Source: org_study_id