Study on the Safety of Encorafenib, Binimetinib, and Ribociclib for Patients with Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of treatments for solid tumors, which are abnormal masses of tissue that usually do not contain cysts or liquid areas. The study involves the use of two medications: Encorafenib and Binimetinib. Encorafenib is a type of medication that targets specific proteins in cancer cells, while Binimetinib works by blocking certain enzymes that promote cancer cell growth. These medications are being tested to see how safe and tolerable they are for patients who have been benefiting from them in previous studies.

The purpose of this study is to monitor the safety and tolerability of these treatments. Participants will continue to receive the study medications as long as they are benefiting from them. The study will last for a maximum of 60 months, during which participants will have regular check-ups to monitor their health and any side effects they may experience. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual medications.

Throughout the study, participants will be closely monitored for any adverse effects, which are unwanted or harmful reactions to the medications. The study aims to identify any serious adverse events (SAEs) that might lead to the permanent discontinuation of the study medications. This information will help researchers understand the long-term safety of Encorafenib and Binimetinib for treating solid tumors.

1 joining the study

Upon joining the study, the participant must be currently receiving treatment and benefiting from a previous encorafenib/binimetinib study. The participant should not have any severe or intolerable side effects related to the treatment.

The participant must agree to follow specific reproductive guidelines and be willing to comply with all scheduled visits and procedures as outlined in the study protocol.

2 treatment administration

The participant will continue receiving the study medications, which may include binimetinib, encorafenib, ribociclib, cetuximab, and vemurafenib. These medications are administered in various forms such as film-coated tablets, hard capsules, and solutions for infusion.

The medications are primarily taken orally, except for cetuximab, which is given as a solution for infusion. The specific dosage and frequency will be determined by the study protocol and the participant’s previous treatment regimen.

3 monitoring and follow-up

The main objective of the study is to monitor the safety and tolerability of the treatment. This involves regular check-ups and assessments to ensure the participant’s well-being.

The study will track any adverse events (AEs) that may lead to the discontinuation of the treatment, as well as any serious adverse events (SAEs).

4 completion of the study

The estimated end date for the study is December 31, 2026. The participant will continue to receive treatment and be monitored until this date or until the study is concluded for other reasons.

Upon completion, the participant will undergo a final assessment to evaluate the overall impact of the treatment.

Who Can Join the Study?

Participants must have solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain liquid areas.
Participants should be currently receiving the study treatment and benefiting from it, as determined by the main doctor in charge. They should not have any severe or intolerable side effects related to the treatment.
Participants must agree to follow specific rules about reproduction, which are detailed in the study’s guidelines for both males and females.
Participants should be willing and able to attend all scheduled visits and follow the treatment plan and other procedures as outlined in the study’s guidelines.
Participants must be able to give signed informed consent, which means they understand and agree to the study’s requirements and restrictions.
The study is open to both male and female participants.
The study includes participants from certain age groups, specifically adults and older adults.
The study may include individuals who are considered part of a vulnerable population, meaning they might need extra protection or care.

Who Cannot Join the Study?

Patients with medical conditions other than solid tumors cannot participate. Solid tumors are a type of cancer that forms in solid organs or tissues.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are not part of the specified clinical trial groups cannot participate. The specific group for this study is not detailed in the provided data.
Patients who are not male or female cannot participate, as the study includes both genders.
Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups that may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Orszagos Onkologiai Intezet	Budapest	Hungary
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Isala Klinieken Stichting	Zwolle	The Netherlands
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Azienda Ospedaliera Di Perugia	Perugia	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Hospital Universitario Central De Asturias	Oviedo	Spain
University Of Debrecen	Debrecen	Hungary
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Semmelweis University	Budapest	Hungary
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
University Of Pecs	Pecs	Hungary
Netherlands Cancer Institute	Amsterdam	The Netherlands
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany
Hospital Teresa Herrera C.H.U.A.C.	A Coruna Galicia	Spain
Hswpiyyh Uwiewpsrkbbfh Mufgcux Dq Vembaavzpm	Santander	Spain
Iwmhyewk Cmrdxz Dckshkluretruunqx	L'hospitalet De Llobregat	Spain
Hgrnhodl Uzcdsfhaeuztq Rxpembwm Dw Myqiah	Malaga	Spain
Lfhoi Gnwuhng Huxulyab Oc Auifsv	Athens	Greece
Sgzbhwxpg Rvhmuch Uxkyjodxru Mrihyav Cyzkce	Nijmegen	The Netherlands
Ajxskao Ulcyz Sneuhiahi Lbvvty Da Buyvddt	Bologna	Italy
Imvexc Idjprrsv Fgxvzozzkihqa Occzzuueznf	Rome	Italy
Hhavfvno Ukktsjfkvimxn Hexzbdjr Tplws y Psmbxu Iruitdcz Chfdfu drgesekpafbatnwmz (zrhh	Badalona	Spain
Hnnjtxpj Veeg duldbztz	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	31.03.2022
France	Not recruiting	31.03.2022
Germany	Recruiting	31.03.2022
Greece	Not yet recruiting	31.03.2022
Hungary	Recruiting	31.03.2022
Italy	Recruiting	31.03.2022
Portugal	Recruiting	31.03.2022
Spain	Recruiting	31.03.2022
The Netherlands	Recruiting	31.03.2022

Trial locations

Investigated drugs:

Encorafenib is a medication used in the treatment of certain types of cancer. It works by blocking the action of a protein that helps cancer cells grow. This medication is often used in combination with other treatments to help stop the spread of cancer.

Binimetinib is another medication used to treat cancer. It targets specific proteins in cancer cells, helping to slow down or stop their growth. Binimetinib is typically used alongside other medications to enhance its effectiveness in treating cancer.

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a lump or mass. As they progress, they may grow larger and potentially spread to other parts of the body. The growth rate and behavior of solid tumors can vary widely depending on their type and location. They are distinct from blood-related cancers, which do not form solid masses.

Trial ID:

2023-509408-13-00

Protocol code:

C4221026

NCT ID:

NCT05203172

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety of Encorafenib, Binimetinib, and Ribociclib for Patients with Solid Tumors

What is this study about?

Who Can Join the Study?

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