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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years

Sex

ALL

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