CompletedNot Applicable

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

United States481 participantsStarted 2021-02-24

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Number of Participants With Serious Adverse Events

Timeframe: 6 months

Duration From Treatment Initiation to Onset of Adverse Events

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Duration of Adverse Events From Onset to Resolution

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Number of Adverse Events Classified According to Type of Management Strategy

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Duration of Treatment Interruption for Axitinib

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 month

Maximum Axitinib Dose Reduction

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Trial details

NCT IDNCT04682587

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-04-05

Results submitted2023-11-02

View on ClinicalTrials.gov More Renal Cell Carcinoma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Number of Participants With Serious Adverse Events

Timeframe: 6 months

Duration From Treatment Initiation to Onset of Adverse Events

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Duration of Adverse Events From Onset to Resolution

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Number of Adverse Events Classified According to Type of Management Strategy

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months

Duration of Treatment Interruption for Axitinib

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 month

Maximum Axitinib Dose Reduction

Timeframe: Observation period of maximum up to 7.1 months; duration of this retrospective study was approximately 1.5 months