Clinical trial · Observational
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
NCT04682587CI-TRIAL-00084308completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avelumab | Drug | Avelumab | ALIAS |
| Axitinib | Drug | Axitinib | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Number of Participants With Different Type of Adverse Events
- timeFrame
- Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months
- description
- An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.
- measure
- Number of Participants With Serious Adverse Events
- timeFrame
- 6 months
- description
- AE was considered serious when it: resulted in death, life-threatening, requires in-participant hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may jeopardize the participant or may require intervention to prevent one of the outcomes listed above. Index date was defined as the initiation of first-line axitinib (used in combination with IO therapy) on or after May 2019, which marked FDA approval of axitinib in combination with avelumab for first-line advanced RCC treatment. Observation period was time from index date to the earliest of initiation of a second line therapy, death, loss to follow-up, or date of chart abstraction. Data, index date, and observation period were on the basis of data extracted from medical charts of participants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZakharia 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. PMID 37087399