NCT04682587

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 481 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Axitinib	Inlyta, axitinib
DRUG	Avelumab	Avelumab, Bavencio
DRUG	Pembrolizumab	Pembrolizumab, Keytruda

Timeline

• Start date: 2021-02-24
• Primary completion: 2021-04-05
• Completion: 2021-04-05
• First posted: 2020-12-24
• Last updated: 2025-01-03
• Results posted: 2025-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study