N/A
Completed N=481
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
Source: ClinicalTrials.gov NCT04682587 ↗Enrolled (actual)
481
Serious AEs
27.0%
Results posted
Jan 2025
Primary outcomePrimary: Number of Participants With Different Type of Adverse Events — 232; 184; 141; 106 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Different Type of Adverse Events |
232; 184; 141; 106; 54 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
130 | — |
| PRIMARY Duration From Treatment Initiation to Onset of Adverse Events |
1.0 | — |
| PRIMARY Duration of Adverse Events From Onset to Resolution |
21.0; 17.0 | — |
| PRIMARY Number of Adverse Events Classified According to Type of Management Strategy |
198; 251; 96 | — |
| PRIMARY Duration of Treatment Interruption for Axitinib |
13.0 | — |
| PRIMARY Maximum Axitinib Dose Reduction |
3.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT04682587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.