Trials Sponsors Conditions Drugs Pricing

Conditions

Metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

Objective Response Rate (ORR) defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements. Responses will be evaluated with a chest and abdominal computed tomography (CT) scan every 8 weeks.

Secondary Outcomes (9)

Progression Free Survival (PFS) is defined as the time interval computed from the date of study enrollment to the date of objective progression according to the RECIST criteria (version 1.1) or death, whatever comes first.
Overall survival (OS) is defined as the time from the date of study enrollment to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.
Overall Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0)
G3/4 Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing a specific adverse event of grade 3/4, according to National Cancer Institute Common Toxicity Criteria (version 5.0)
Early Objective Response Rate (EORR) is defined as the percentage of patients, relative to the total of the enrolled subjects, achieving a ≥20% decrease in the sum of diameters of RECIST target lesions at week 8 compared to baseline
+4 more secondary outcomes

Interventions

Braftovi 75 mg hard capsulesType not reported

Erbitux 5 mg/mL solution for infusionType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Braftovi 75 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry record
Formulated product
Erbitux 5 mg/mL solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Braftovi 75 mg hard capsules
Named ingredient: encorafenib
View registry record
Erbitux 5 mg/mL solution for infusion
Named ingredient: Cetuximab
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically proven diagnosis of colorectal adenocarcinoma
Age ≥ 18 years
ECOG Performance status ≤ 1

Sponsors & Collaborators

Fondazione GONO G.I.
Otherlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (17)

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Carlotta Antoniotti050992192 carlottantoniotti@gmail.com

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Lisa Salvatore0630156318 lisa.salvatore@policlinicogemelli.it

San Raffaele Hospital

Milan, 20132, Italy

Monica Ronzoni0226436523

Central Study Contacts

Laura Delliponti

00050992192 laura.delliponti@gmail.com

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

March 12, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-509088-26-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:20:47 UTC

Documents

BRICKET_Protocol_v1-1_31May2024_Clean_Redatto

You may not qualify if:

Known hypersensitivity or contraindications to trial drugs or any component of the trial drugs
Known history of acute or chronic pancreatitis within 6 months prior to the start of the treatment
History of chronic inflammatory bowel disease or Crohn’s disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to first dose
Impaired hepatic function, defined as Child-Pugh class B or C
Clinically significant cardiovascular diseases, including any of the following: - history of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤6 months prior to registration; - congestive heart failure requiring treatment (New York Heart Association Class II and above); - recent history (within 1 year prior to registration) or presence of clinically significant cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia)
QT interval corrected for heart rate >480 msec at screening and rate uncontrolled atrial fibrillation and paroxysmal supraventricular tachycardia
Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) from the screening phase until 1 month after the last trial treatment
Residual CTCAE ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of grade 2 alopecia or grade 2 neuropathy
Active eye disorders, including keratitis, ulcerative keratitis or severe dry eye
Discontinuation of previous treatment with encorafenib and/or cetuximab with or without chemotherapy due to encorafenib- and/or cetuximab-related adverse events
Symptomatic brain metastases or spinal cord compression. Notes: Patients previously treated or untreated for these conditions who are asymptomatic in the absence of corticosteroid and antiepileptic therapy are allowed. Brain metastases or spinal cord compression must be stable for ≥ 4 weeks, with imaging (e.g., magnetic resonance imaging [MRI] or computed tomography [CT]) demonstrating no current evidence of progressive brain metastases or spinal cord compression at screening
Leptomeningeal disease
Other co-existing malignancies or malignancies diagnosed within the last 5 years except for adequately treated localised basal and squamous cell carcinoma or cervical cancer in situ
Treatment with any investigational drug within 30 days prior to enrolment or two investigational agent half-lives (whichever is longer)
Impaired gastrointestinal function (i.e., uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, small bowel resection) or disease which may significantly alter the absorption of oral study intervention or recent changes in bowel function suggesting current or impending bowel obstruction
+2 more criteria

Single arm phase II study of ctDNA-guided encorafenib plus cetuximab retreatment in patients with BRAF V600E mutated mCRC. BRICKET study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (17)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (17)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations