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NCT05551039 · ClinicalTrials.gov registry record
An Observational Study, Called RegoFlex EU, to Learn More About the Use of Stivarga at Reduced Doses as Recommended (Flexible Dosing) to Treat People With Metastatic Colorectal Cancer in Real World Settings in Europe
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 300
- Enrollment target
NCT05551039: Completed study, sponsored by Bayer.
NCT05551039 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05551039 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
Study Summary
This is an observational study in which data from patients with metastatic colorectal cancer in three European countries who received STIVARGA® (regorafenib), are collected. In observational studies, only observations are made without specified advice or interventions. Metastatic colorectal cancer (mCRC) is a cancer that starts in the large bowel or the rectum (the lowest part of the gut) and has spread to other parts of the body. Regorafenib is an anti-cancer drug that blocks several proteins called enzymes, which are involved in the development and growth of cancer. A wide range of such enzymes called tyrosine kinases are targeted. In 2013, regorafenib was approved in Europe for doctors to prescribe to people with mCRC who have previously been treated or cannot receive other available treatments. It is known that doctors may change/reduce the amount (the dose) of regorafenib they give (flexible dosing), so that the patients better tolerate the treatment. However, little information is available on the doses of regorafenib given in France, Italy, and Belgium in usual practice. In this study researchers want to learn more about how and in which amount regorafenib is usually given to patients with mCRC in France, Italy, and Belgium: * at the beginning * during, and * at the end of the regorafenib therapy. In addition, the study team will collect data about/if: * the treatment duration at each treatment dose of regorafenib, * the number of people who received reduced initial dosing of regorafenib in real word settings in France, Italy, and Belgium, * reduced (flexible) initial dosing of regorafenib allows patients to stay longer on treatment. To answer these questions, the researchers will look back at cases that have already happened when the study begins. The data will be collected through an online case report form. The doctors will provide case histories of mCRC patients who started regorafenib treatment in most recent 3 years and 4 months (from January 1,
Interventions
- OTHER Retrospective patient chart review
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2023-01-15 |
What the finished NCT05551039 record still lists
NCT05551039 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Retrospective patient chart review is the first listed.
NCT05551039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05551039 about?
NCT05551039 is a clinical study titled "An Observational Study, Called RegoFlex EU, to Learn More About the Use of Stivarga at Reduced Doses as Recommended (Flexible Dosing) to Treat People With Metastatic Colorectal Cancer in Real World Settings in Europe". This is an observational study in which data from patients with metastatic colorectal cancer in three European countries who received STIVARGA® (regorafenib), are collected. In observational studies, only observations are made without specified advice or interventions. Metastatic colorectal cancer ...
What is the current status of trial NCT05551039?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2022-08-15. Estimated completion is 2023-01-15.
What interventions are being tested in trial NCT05551039?
The interventions under investigation include: Retrospective patient chart review (OTHER).
Who is sponsoring clinical trial NCT05551039?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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