Study Comparing Sotorasib and Panitumumab with Other Drug Combinations for Patients with Metastatic Colorectal Cancer and KRAS p.G12C Mutation

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What is this study about?

This clinical trial is focused on studying treatments for metastatic colorectal cancer, a type of cancer that starts in the colon or rectum and has spread to other parts of the body. The study is specifically for patients whose cancer has a particular genetic change called the KRAS p.G12C mutation. The trial will compare the effectiveness of a combination of two medications, sotorasib and panitumumab, against other treatment options chosen by the doctors, which may include trifluridine and tipiracil or regorafenib.

The purpose of the study is to see how well these treatments work in stopping the cancer from getting worse. Participants will receive either the combination of sotorasib and panitumumab or one of the other treatment options. The study will monitor the participants over time to see how long the treatments can keep the cancer from progressing and to assess any side effects. The medications will be given in different forms: sotorasib is taken as a tablet by mouth, while panitumumab is given through an infusion, which means it is delivered directly into the bloodstream through a vein.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable information on the best treatment options for patients with this specific type of colorectal cancer. The trial is expected to continue until 2025, allowing researchers to gather comprehensive data on the treatments’ effectiveness and safety.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This assignment is done to compare the effectiveness of different treatments for colorectal cancer with a specific genetic mutation (KRAS p.G12C).

2 treatment group assignment

The patient may receive a combination of sotorasib and panitumumab or a treatment chosen by the investigator, which could include trifluridine and tipiracil or regorafenib.

3 medication administration

If assigned to the sotorasib and panitumumab group, the patient will take sotorasib orally at a dose of 240 mg or 960 mg once daily. Panitumumab will be administered through an intravenous infusion.

If assigned to the investigator’s choice group, the patient will take trifluridine and tipiracil or regorafenib orally. The specific dosage and frequency will be determined by the investigator.

4 monitoring and assessments

Throughout the study, the patient’s health and response to treatment will be monitored. This includes regular assessments of disease progression and any side effects experienced.

The patient’s overall survival and response to treatment will be evaluated using specific criteria to determine the effectiveness of the treatment.

5 end of study participation

The study is expected to conclude by March 2025. At the end of the study, the patient’s participation will be complete, and final assessments will be conducted to gather data on the treatment’s impact.

Who Can Join the Study?

The patient must agree to participate and sign a consent form before any study activities begin.
The patient must have a heart rhythm measurement called QTcF that is less than or equal to 470 milliseconds.
The patient must be able to take pills by mouth and be willing to keep track of taking the study medication every day.
The patient must be 18 years of age or older.
The patient must have a specific type of colorectal cancer with a mutation called KRAS p.G12C, confirmed by a special test.
The patient must have received at least one previous treatment for cancer that has spread (metastatic disease) and must have tried certain medications unless they are not suitable for them.
The patient must be willing to provide a sample of their tumor tissue or agree to have a biopsy done before joining the study.
The patient must have measurable disease according to specific criteria, and any areas previously treated with radiation must have shown growth after treatment to be considered measurable.
The patient must have a performance status of 2 or less, which is a measure of their ability to perform daily activities.
The patient must have a life expectancy of more than 3 months, as judged by the doctor.
The patient must have adequate blood and organ function, which includes specific levels of blood cells, liver enzymes, and kidney function, as determined by tests done within two weeks before starting the study.

Who Cannot Join the Study?

Patients who do not have a specific type of colorectal cancer with a genetic change called KRAS p.G12C mutation cannot participate.
Patients who have not been previously treated for their colorectal cancer are not eligible.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not allowed to 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
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario De Navarra	Pamplona	Spain
Universitaetsmedizin Goettingen	Goettingen	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Edouard Herriot	Lyon	France
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Fondazione Poliambulanza	Brescia	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
St. Luke’s Hospital S.A.	Thessaloniki	Greece
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ayzeyvt Onlxveudbzk S Gtderkog Abaqcipjha	Rome	Italy
Kesyumrw dwx Udtgisznfpnl Mtokssmu Atf	Munich	Germany
Amqminn Uyk Ivywy Dn Rwhosb Ecqbiz	Reggio Emilia	Italy
Hmdrhxpe Du Lt Sbbgp Cthi I Stcq Psd	Barcelona	Spain
Fmymyruvs Pget Lx Isktiregwgntn Bjpnifdkq Dkk Hzdibgat Udpfrtunhzvdw Lu Prs	Madrid	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	19.04.2022
Germany	Not recruiting	19.04.2022
Greece	Not recruiting	19.04.2022
Italy	Not recruiting	19.04.2022
Spain	Not recruiting	19.04.2022

Trial locations

Investigated drugs:

Sotorasib is a medication used in this trial to treat patients with a specific type of colorectal cancer that has a KRAS p.G12C mutation. It works by targeting and inhibiting the mutated KRAS protein, which is involved in the growth and spread of cancer cells.

Panitumumab is another medication used in combination with sotorasib in this trial. It is a type of targeted therapy known as a monoclonal antibody. Panitumumab works by binding to a protein on the surface of cancer cells, which can help slow down or stop their growth.

Trifluridine and Tipiracil is a combination medication that is one of the options chosen by investigators for treating colorectal cancer in this trial. Trifluridine is a type of chemotherapy that interferes with the DNA of cancer cells, preventing them from multiplying. Tipiracil helps increase the effectiveness of trifluridine by preventing its breakdown in the body.

Regorafenib is another treatment option in this trial. It is a type of targeted therapy that works by blocking several enzymes that promote cancer cell growth. Regorafenib is used to treat colorectal cancer that has spread to other parts of the body.

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, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The disease can spread to other parts of the body if not detected early. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of colorectal cancer can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-511187-81-00

Protocol code:

20190172

NCT ID:

NCT05198934

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Sotorasib and Panitumumab with Other Drug Combinations for Patients with Metastatic Colorectal Cancer and KRAS p.G12C Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?