Cetuximab as salvage therapy in patients with neo wild-type RAS/RAF metastatic colorectal cancer. A Proof-of-concept study

Cetuximab as salvage therapy in patients with neo wild-type RAS/RAF metastatic colorectal cancer. A Proof-of-concept study - CETIDYL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002115-26-FR

Enrollment

Registered

2019-09-05

Start date

2019-11-05

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

Trade Name: Erbitex Product Name: Cetuximab Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of signed and dated informed consent and stated willingness to comply with all study procedures and availability for the duration of the study, 2. Male or female subjects, =18 years of age, 3. ECOG performance status (ECOG PS, Appendix 15.1) =2, 4. Unresectable metastatic RAS mutant (either KRAS or NRAS tumor gene mutation) colorectal cancer, 5. At least one (=1) measurable and/or evaluable liver metastasis, 6. Prior therapy (resistant or intolerant) with fluoropyrimidines, oxaliplatin, irinotecan and antiangiogenic agent (ie, bevacizumab and/or aflibercept), 7. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: - Hematological status: neutrophils (ANC) =1.5x109/L; platelets =100x109/L; haemoglobin =9g/dL, - Adequate renal function: serum creatinine clearance (MDRD) = 50 mL/min/1,73 m2 - Adequate liver function: serum bilirubin =1.5x upper normal limit (ULN), alkaline phosphatase =65 years) yes F.1.3.1 Number of subjects for this age range 72

Exclusion criteria

Exclusion criteria: 1. Known allergy or hypersensitivity reactions to any study drug, 2. Women who are pregnant or breastfeeding, 3. Inability to comply with study and follow-up procedures as judged by the Investigator, 4. Patient with BRAF mutant colorectal cancer 5. History of interstitial lung disease 6. Treatment with strong CYP3A4-enzyme inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John’s wort for patients of cohort #2 7. Treatment with strong CYP3A4-enzyme inhibitors (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) for patients of cohort #2 8. Treatment with strong UGT1A inhibitors (e.g. atazanavir, gemfibrozil, indinavir) for patients of cohort # 2 9. Patients of cohort #2 with known UGT1A deficiency 10. Uncontrolled illness, including but not limited to ongoing bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination/ clinical laboratory finding that leads to a reasonable suspicion of a disease/condition that contraindicates the use of any of investigational drugs that may affect the interpretation of the results, or that may render the subject at high risk of treatment complications. 11. Patient with current intestinal obstruction or history of chronic inflammatory bowel disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy (response rate using RECIST 1.1) of cetuximab with (cohort #2) or without (cohort #1) irinotecan in patients with neo wild-type metastatic colorectal cancer;Secondary Objective: - To evaluate progression-free survival (PFS), - To evaluate overall survival (OS) - To evaluate disease control rate (DCR) - To evaluate safety ;Primary end point(s): The primary endpoint of the study is response rate.;Timepoint(s) of evaluation of this end point: Treatment evaluation visit	—

Measure

Time frame

Main Objective: To evaluate the efficacy (response rate using RECIST 1.1) of cetuximab with (cohort #2) or without (cohort #1) irinotecan in patients with neo wild-type metastatic colorectal cancer;Secondary Objective: - To evaluate progression-free survival (PFS), - To evaluate overall survival (OS) - To evaluate disease control rate (DCR) - To evaluate safety ;Primary end point(s): The primary endpoint of the study is response rate.;Timepoint(s) of evaluation of this end point: Treatment evaluation visit

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints are: - PFS is defined as the time from the date of starting treatment to the date of progression or death (from any cause). Patients alive without documented objective PD at the time of the final analysis will be censored at the date of their last objective tumor assessment. - OS is defined as the time from the date of starting treatment to the date of patient death (from any cause) or to the last date the patient was known to be alive. Patients still alive at the time of the analysis will be censored using the date of last news. - Disease control rate (DCR) is defined as the percentage of patients achieving CR, PR, or stable disease (SD). Secondary safety endpoints are: - Toxicity will be evaluated according to the U.S. National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. ;Timepoint(s) of evaluation of this end point: date of progression or date of patient death	—

Measure

Time frame

Secondary end point(s): Secondary efficacy endpoints are: - PFS is defined as the time from the date of starting treatment to the date of progression or death (from any cause). Patients alive without documented objective PD at the time of the final analysis will be censored at the date of their last objective tumor assessment. - OS is defined as the time from the date of starting treatment to the date of patient death (from any cause) or to the last date the patient was known to be alive. Patients still alive at the time of the analysis will be censored using the date of last news. - Disease control rate (DCR) is defined as the percentage of patients achieving CR, PR, or stable disease (SD). Secondary safety endpoints are: - Toxicity will be evaluated according to the U.S. National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. ;Timepoint(s) of evaluation of this end point: date of progression or date of patient death

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Countries

France

Contacts

Public ContactIsabelle Buffet

Hôpital Foch

i.buffet@hopital-foch.com331 46 25 37 48

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026