Kidney Cancer Clinical Trial
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
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
Full 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
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
Exclusion Criteria:
There are no exclusion criteria for this study
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New York New York, 10017, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.