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NCT04682587 · ClinicalTrials.gov registry record
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 clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 481
- Enrollment target
NCT04682587: Completed study, sponsored by Pfizer.
NCT04682587 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 481 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04682587 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 481 participants
- Enrollment target
Study 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
Primary Outcome
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-
Interventions
- DRUG Pembrolizumab
- DRUG Axitinib
- DRUG Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2021-04-05 |
What the finished NCT04682587 record still lists
NCT04682587 is an observational study that tracks outcomes without assigning an intervention. The registered 481 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04682587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04682587 about?
NCT04682587 is a clinical study titled "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". 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
What is the current status of trial NCT04682587?
This trial is currently completed. The enrollment target is 481 participants. The study started on 2021-02-24. Estimated completion is 2021-04-05.
What interventions are being tested in trial NCT04682587?
The interventions under investigation include: Pembrolizumab (DRUG), Axitinib (DRUG), Avelumab (DRUG).
Who is sponsoring clinical trial NCT04682587?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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