Not recruiting

Study Comparing Panitumumab and Regorafenib Sequence for Patients with Metastatic Colorectal Cancer Resistant to Previous Treatments

Fast replyRegistered drugNo 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 is focused on studying treatments for metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study involves two medications: Vectibix (also known as panitumumab) and Stivarga (also known as regorafenib). These medications are used to treat patients whose cancer has not responded to previous therapies. The purpose of the study is to compare the effectiveness of two different treatment sequences using these medications.

Participants in the study will be divided into two groups. One group will receive panitumumab first, followed by regorafenib if the disease progresses. The other group will receive the treatments in the reverse order, starting with regorafenib and then switching to panitumumab if needed. The study will help determine which sequence of treatments is more effective for patients with this type of cancer.

The trial will last for a period of time during which participants will receive the treatments and be monitored for their health and response to the medications. The main goal is to see which treatment sequence helps patients live longer. The study will also look at the side effects of the treatments and how well the cancer responds to them. Participants will receive either the study medications or a placebo, depending on the group they are assigned to.

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
Randomization
Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment sequence.
Step 2
Treatment sequence
If assigned to arm A, you will first receive panitumumab, which is administered through an intravenous infusion. This treatment will continue until there is evidence of disease progression.
If assigned to arm B, you will first receive regorafenib, which is taken orally in the form of film-coated tablets. This treatment will also continue until there is evidence of disease progression.
Step 3
Second-line treatment
After disease progression, the treatment sequence will switch. In arm A, you will begin taking regorafenib orally. In arm B, you will start receiving panitumumab intravenously.
Step 4
Monitoring and assessments
Throughout the trial, regular assessments will be conducted to monitor your health and the effectiveness of the treatment. These assessments will include physical examinations, blood tests, and imaging studies.
The objective response to the treatment will be evaluated every 8 weeks to determine the progression of the disease.
Step 5
End of trial
The trial is expected to conclude by June 2025. At the end of the trial, the data collected will be analyzed to determine the overall survival and other outcomes related to the treatment sequences.

Who can join the trial?

22 criteria

Must be at least 18 years old.
Have received at least one treatment after the first anti-EGFR therapy and before the study screening.
Provide a blood sample for a test called a liquid biopsy within 28 days before joining the study.
Have a specific genetic status called RAS and BRAF wild type in a blood test at screening. This means certain genes do not have specific mutations.
Sign a written agreement to participate in the study.
Expected to live for at least 12 more weeks.
Provide tissue samples from the original tumor or its spread for further analysis.
Provide biological samples for additional research.
Have certain levels of blood cells: neutrophils at least 1.5 x 10⁹/L, platelets at least 100 x 10⁹/L, and hemoglobin at least 9 g/dl.
Have certain liver function levels: total bilirubin no more than 1.5 times the normal limit, ASAT and ALAT no more than 2.5 times the normal limit (or less than 5 times if there is liver spread), and alkaline phosphatase no more than 2.5 times the normal limit (or less than 5 times if there is liver spread).
Have a creatinine clearance of at least 50 mL/min or serum creatinine no more than 1.5 times the normal limit. These are measures of kidney function.
Sign a written agreement for molecular analyses.
Women who can have children must have a negative pregnancy test at the start of the study. Women are considered able to have children unless they have not had a period for 12 months, are surgically unable to have children, or are not sexually active.
Participants and their partners must agree to avoid pregnancy during the study and for 8 weeks after the last treatment. This means using effective birth control methods.
Must be willing and able to follow the study rules.
Have a confirmed diagnosis of colorectal cancer.
Have at least one tumor that can be measured according to specific guidelines called RECIST1.1.
Have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but being able to do light work.
Have been treated for cancer that has spread with certain drugs or not be suitable for them.
Have a specific genetic status called RAS and BRAF wild type in the original tumor or its spread, confirmed by a local lab.
Have had a first-line anti-EGFR treatment that resulted in at least a partial response or stable disease for 6 months or more.
At least 4 months must have passed since the end of the first anti-EGFR treatment and the study screening.

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

Azienda Ospedaliera Ordine Mauriziano Di Torino
Responsive
Turin, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Azienda Ospedaliero Universitaria Di Sassari
Responsive
Sassari, Italy

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

Panitumumab
is a medication used in this trial to treat patients with metastatic colorectal cancer. It is a type of targeted therapy known as a monoclonal antibody. Panitumumab works by attaching to a specific protein on the surface of cancer cells, which can help slow down or stop the growth of the cancer.
Regorafenib
is another medication used in this trial for treating metastatic colorectal cancer. It is a type of targeted therapy called a kinase inhibitor. Regorafenib works by blocking certain proteins that cancer cells need to grow and spread, which can help control the disease.

What is already known about the treatment

Panitumumab
Panitumumab is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer, particularly in patients with specific genetic profiles. The main therapeutic use of Panitumumab is for colorectal cancer that has spread and is resistant to other treatments. It works by targeting and blocking the epidermal growth factor receptor (EGFR) on cancer cells, which helps to slow down or stop their growth. Panitumumab is classified as a monoclonal antibody, a type of targeted cancer therapy.
Regorafenib
Regorafenib is taken orally in the form of a tablet. It is being evaluated in clinical trials for its role in treating metastatic colorectal cancer, especially in patients who have not responded to other treatments. The primary therapeutic indication for Regorafenib is colorectal cancer that has spread and is resistant to standard therapies. It works by inhibiting multiple protein kinases involved in cancer growth and blood vessel formation, effectively slowing down the progression of the disease. Regorafenib is classified as a multikinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, cancer cells can invade nearby tissues and spread to other parts of the body, a process known as metastasis. The progression of colorectal cancer can vary, with some cases remaining localized for a long time, while others spread more quickly. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. Early detection through screening can significantly impact the course of the disease.