Continued Regorafenib Treatment for Patients with Solid Tumors from Previous Bayer Studies

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What is this study about?

This clinical trial focuses on the continued treatment of patients with solid malignant tumors, which are a type of cancer that forms in solid organs or tissues. The study involves the use of a medication called regorafenib, which is provided in the form of a film-coated tablet. Regorafenib is a chemical substance that has been used in previous studies sponsored by Bayer. The purpose of this study is to allow participants who have been receiving regorafenib in earlier Bayer-sponsored trials to continue their treatment if they are benefiting from it.

Participants in this study will continue to take regorafenib orally, as they have in their previous trials. The study is designed to monitor the safety of ongoing treatment with regorafenib and to document any serious adverse events, which are significant side effects that may occur. The study will also track any changes in the dosage that participants may need during the course of the trial. The treatment period for this study can last up to 26 weeks, depending on the participant’s response and the investigator’s assessment.

This trial is open-label, meaning that both the participants and the researchers know which treatment is being administered. It is a single-arm study, which means all participants will receive regorafenib, and there is no comparison group receiving a different treatment or a placebo. The study aims to ensure that participants who are benefiting from regorafenib can continue their treatment safely after their previous study has concluded or been stopped early.

1 joining the study

Participation begins after completing a previous Bayer-sponsored study involving regorafenib.

Eligibility requires current treatment with regorafenib and a determination by the investigator that the treatment is beneficial.

2 treatment continuation

Continue taking regorafenib as a film-coated tablet for oral use.

Dosage and frequency are determined by the guidelines of the previous study protocol.

3 monitoring and assessment

Regular monitoring for any serious adverse events (SAEs) and other specified adverse events (AEs) is conducted.

The severity of any adverse events is assessed to ensure safety.

4 dose adjustments

If necessary, dose modifications may occur based on the participant’s response and any adverse events experienced.

5 study completion

The study is estimated to end on April 27, 2026.

Participants will continue treatment until the study reaches its completion date or if the treatment is no longer beneficial.

Who Can Join the Study?

The participant must have a type of cancer called a solid malignant tumor.
The participant must currently be part of a Bayer-sponsored study where they are receiving a medication called regorafenib.
The participant must be benefiting from the treatment with regorafenib alone, meaning it is helping them.
The participant must meet the requirements to start another cycle of treatment, as per the study’s guidelines.
If the participant has any ongoing side effects that require a break from treatment, these side effects must be back to their usual state or stable, and not need further breaks from treatment, as decided by the study doctor.
Both male and female participants are eligible.
The study includes participants from certain age groups, which are generally adults.
The study may include individuals who are considered part of a vulnerable population.

Who Cannot Join the Study?

Patients who do not have solid malignant tumors cannot participate. These are types of cancer that form solid masses or lumps in the body.
Patients who are not currently receiving regorafenib in a Bayer-sponsored clinical trial cannot participate. Regorafenib is a medication used to treat certain types of cancer.
Patients who have not been assessed by the principal investigator as benefiting from regorafenib treatment cannot participate. The principal investigator is the main person responsible for the trial.
Patients who are not within the specified age ranges cannot participate. The age ranges are typically defined by the trial.
Patients who are not part of the specified clinical trial groups cannot participate. These groups are defined by the trial based on certain characteristics.
Both male and female patients are eligible, so exclusion is not based on gender.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France
Hopital Huriez	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	11.03.2024
Spain	Not recruiting	11.03.2024

Trial locations

Investigated drugs:

Regorafenib

Regorafenib is a medication used in this clinical trial. It is designed to help patients who have been receiving it in a previous Bayer-sponsored study. The main goal is to allow these patients to continue their treatment with regorafenib if they are benefiting from it. This medication is typically used to treat certain types of cancer by slowing down the growth of cancer cells and cutting off the blood supply that tumors need to grow. The trial aims to ensure the continued safety and effectiveness of regorafenib for these patients.

Solid Malignant Tumors – These are abnormal growths of tissue that form solid masses and are cancerous in nature. They can occur in various parts of the body, such as the breast, lung, prostate, or colon. As they grow, they may invade nearby tissues and organs, potentially causing damage. The progression of these tumors can vary, with some growing slowly and others rapidly. They may also spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The behavior and impact of solid malignant tumors depend on their location, size, and the specific type of cancer cells involved.

Trial ID:

2023-507084-19-00

Protocol code:

22551

Trial Phase:

Therapeutic exploratory (Phase II)

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Continued Regorafenib Treatment for Patients with Solid Tumors from Previous Bayer Studies

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?