Not recruiting

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

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 4
Dose adjustments
If necessary, dose modifications may occur based on the participant's response and any adverse events experienced.
Step 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 trial?

8 criteria

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 trial?

7 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hopital Beaujon
Verified
Clichy, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

Regorafenib

What is already known about the treatment

Regorafenib – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating solid malignant tumors. Regorafenib is primarily used for patients who have previously participated in Bayer-sponsored studies and are benefiting from the treatment. It works by inhibiting multiple protein kinases, which are involved in tumor growth and progression, thereby slowing down the spread of cancer cells. Regorafenib is classified as a multikinase inhibitor in pharmacology.

Investigated diseases

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.