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
Fauopgfhir Idfbb Cl Gznqtr Ocapjuln Mufrryqe Pfrmpngtvht	Milan	Italy
Izwhfknm Ryrdumzds Pcw Ll Sqlzzj Dfi Twfvbo Djjn Aznihdh Ijwf Svrdko	Meldola	Italy
Ihhhz Onytbmfd Pvitfwqowyn Spr Mewryuj	Genoa	Italy
Uyxantvuvlddeynil Pzahvpnbyso Djqkr Mxtlgk	Ancona	Italy
Axazyrb Onhxcgipfro Uvuzcqistbdew Cdrgyqzvimhm Dhepb Swoqrv E Druiu Strtvvk Dp Toxzsl	Turin	Italy
Arymhnd Odrcoumcivaelxrkvqzpzhmit Mmfdryri Dlprn Cngzca	Novara	Italy
Ikfeaq Iodhkadl Focmrhysjnxyw Owbcglgttma	Rome	Italy
Aykjwfw Snajdubme Ukutzdzwcpafx Fmxofa Cjiuqqir	Udine	Italy
Fpzpzohfza Idjfougteq Iqeomofc Nujmfrogrgv Bmncs	Milan	Italy
Afxoplm Oxxfomgrnxy Umloesbmpdpme Pktlxo	Pisa	Italy
Iumuscev Omhbnutofc Vgwfaz	Padua	Italy
Acqzpmu Ooogyntszsyphprwzbeuukxes Pgmdetpqtfo Go Rbpkudvmssjl Mwfnd Dc Cruoalq	Catania	Italy
Aduussu Socqappem Lbczry Vskwube	Viterbo	Italy
Phl Figqrozigi Dg Cdhoi E Rdkdgvles Ckeq G Pnqdlj	Tricase	Italy
Afuoeje Seulajxub Lsebwx Rrmf 2	Rome	Italy
Obxvmfnk Ai Mjznn Abeh Mydfuu Aia Frpcs	Fermo	Italy
Avqmhts Ujy Tvgvgpk nevx ogugv	Leghorn	Italy
Egms Oszvgayybwn Okxeluvv Glokchwi Dv Goeyxa	Genoa	Italy
Ueirhsubeferjvqcs Ctyeup Bdjlbjcgfm Dh Rswz	Rome	Italy
Ihubymam Dk Cjfddzxu Fzlxzhcnle Dua Pakzfpon Pji Luzcqtkxpj Ihotr	Candiolo	Italy
Afyuxbc Uda Tshwoiy Clybeo	Prato	Italy
Agcllrl Szeakozfr Lupnqa Cpkfi Db Tgwilg	Turin	Italy
Oguvwngw Fkaxgxawljrznuzy Ilkio Tljvsogs Glmhdoq Icnyb	Rome	Italy
Abxucja Udh Ikepa Do Rypukk Eajjii	Reggio Emilia	Italy
Armpkyt Utg Thyyams Sht Ebp	Arezzo	Italy
Awemnbm Ucbov Swwkeusjj Lwgrbw Dkhnq Rpddzwa	Faenza	Italy
Aavqytz Sqzskiuxu Liocir Dcayb Pyshircyg Dq Brtkmo	Ponderano	Italy
Ahybypi Punyqbzxbdu Puy I Skzyctr Segbgjxk	Trento	Italy
Clis Shefgxia Dpnln Smleexfczf	San Giovanni Rotondo	Italy
Adxqhpi Uclob Lsmnqe Sjhxd Shzlepztm N 8 Bwuppx	Vicenza	Italy
Aheknhh Onphkptuvru Okohbqfz Rgqdvcf Mjtbzv Nvba	Pesaro	Italy
Aseubrk Otvmzswjxxm Olwbhx Mmhluhjzof Dv Tassof	Turin	Italy
Ablmfmk Stcbhzbowcsgtg Lyafqm 2	Savona	Italy
Alwghhy Outzqdbjdxw Uguqnsihdzczk Dv Cyvrcilt	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?

Who Cannot Join the Study?