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
NCT number | NCT04682587 |
Other study ID # | A4061097 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 24, 2021 |
Est. completion date | April 5, 2021 |
Verified date | September 2022 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
United States | Pfizer | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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 |
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