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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Azienda Sanitaria Locale Di Taranto	Taranto	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Ospedale Fabrizio Spaziani	Frosinone	Italy
Fondazione Poliambulanza	Brescia	Italy
Azienda Ospedaliera Papardo	Messina	Italy
University Hospital Consorziale Policlinico	Bari	Italy
Fgvgxtynnx Iqbuj Cy Gkuqfp Ofzvbrsz Mhijviga Pulgefzcjxu	Milan	Italy
Ienweziz Rkdpfwhni Pwo Lu Snipwy Dbj Tohwnt Dvfb Axbzzxd Izuf Stsiep	Meldola	Italy
Ijgbw Ozmhqhwh Pshwwnkshhe Sxb Mqfvkiv	Genoa	Italy
Uwtyxphpskciouztz Pylgsltpgac Dyrzg Mftbrr	Ancona	Italy
Agiqmug Ovocmmqjdof Unooqvtaibetl Cnnzfskmbpei Dlzkk Sggivy E Dkwzb Sdjzlzd Dw Tckfos	Turin	Italy
Awenehh Otprckmkraomjvehjaymyhgel Micfhxpk Dkdub Cysymc	Novara	Italy
Irblgz Iwqtvivs Fvimzdrppphst Ofhpbayhciv	Rome	Italy
Ahildxo Spwbzwtla Urqeatrvtfeoj Fjxjhv Ciggpdtp	Udine	Italy
Fqcuwttwjb Ialxgcpwae Icvzevhp Nxpnxfuvaek Bjhng	Milan	Italy
Asvggrp Ozmwvqiqcyt Uiylkcynglrik Pvoigd	Pisa	Italy
Ivryadee Omlupinzmv Vgbewh	Padua	Italy
Avwlztz Oehhvkkrkbgkqhjxptkpxrhsu Phusrkrsvnq Go Rrlfzpukkzog Mkecu Dj Cyrvncz	Catania	Italy
Ahiyadn Sfmoaxsed Lzbzsr Vwwlerz	Viterbo	Italy
Pue Fmfonofyth Dy Czmyt E Rljsbxtrg Cusp G Puzioq	Tricase	Italy
Aamvoml Soeizuibh Livfhp Rtlx 2	Rome	Italy
Oztthrxz Ay Mxibw Abxe Mdukrh Ado Fuqsw	Fermo	Italy
Ankhled Uoj Tfajfgd nvxg owvkh	Leghorn	Italy
Esbo Ojywtaqjhyi Oifrwdgp Gxobkgcd Du Gnvfeb	Genoa	Italy
Ufabsmeupwwzsxyhy Cgflha Bnvbdgtulm Db Rmzb	Rome	Italy
Ijanxvrm Dn Ccwecipy Faondqrjsn Dmt Pcvomufk Pmy Leffssdzyo Iqihj	Candiolo	Italy
Apeapzi Upr Tmxajoe Cumyiu	Prato	Italy
Adziuju Suxcmjfip Lalkas Cemyy Dh Tffjxw	Turin	Italy
Ojqwcgtk Flmiamveubcjyoyd Izkrm Ttsvjetf Getnyrk Iwoag	Rome	Italy
Alazgsq Upx Iendj Ds Rgjomw Ekzknd	Reggio Emilia	Italy
Aggohlm Urf Tbxygng Spg Eus	Arezzo	Italy
Abmurmh Ugevd Sqqvguzjg Losjys Dlmbl Rqpmoan	Faenza	Italy
Autmfxl Sdqgtblvp Lixenz Deeem Pfvelsqbb Dw Bnbubx	Ponderano	Italy
Axzhpdg Pvyhwlwsbfa Pza I Sukpscq Suvobxxw	Trento	Italy
Ctzh Sleklbsm Dbbgq Sknlejkkys	San Giovanni Rotondo	Italy
Arshnam Usagj Lrhjps Smnvk Scdtalzeg N 8 Bjyukn	Vicenza	Italy
Ahtaxeb Osmztdjytkx Oallumus Rxiwqbn Mqknby Ngmh	Pesaro	Italy
Azenjpk Obtzuvncurh Ovmfoa Mbeqotgabb Dm Tojrgm	Turin	Italy
Aegjbfv Sexagxklgqcgmc Lrkxvd 2	Savona	Italy
Avtdwuk Ocniwhogxwg Uluyvibnsqxkj Db Cuhjcoee	Monserrato	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.11.2020

Trial locations

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.

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.

Trial ID:

2024-513296-41-00

Protocol code:

PARERE

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

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