CETUXIMAB for Metastatic colorectal cancer

Inclusion criteria

• {"criterion_text":"- 3.\tHistologically- or cytologically-confirmed mCRC that is metastatic."}
• {"criterion_text":"- 4.\tPresence of BRAF V600E mutation in tumor tissue previously determined according to the guidelines of each center, any time point before the enrollment in the study."}
• {"criterion_text":"- 6.\tEligible to receive cetuximab per locally approved label with regard to tumor RAS status, any time point before the enrollment in the study."}
• {"criterion_text":"- 7.\tProgression of disease after 1 or 2 prior regimens in the metastatic setting"}

Exclusion criteria

• {"criterion_text":"- 5.\tSignificant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1."}
• {"criterion_text":"- 6.\tEvidence of bleeding diathesis or clinically significant coagulopathy (in the absence of therapeutic anticoagulation)."}
• {"criterion_text":"- 9.\tTumors with microsatellite instability or mismatch repair deficiency."}
• {"criterion_text":"- 17.\tImpaired gastrointestinal (GI) function or disease that may significantly alter the absorption of encorafenib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)."}
• {"criterion_text":"- 18.\tConcurrent or previous other malignancy within 5 years of study entry without Sponsor approval, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy."}
• {"criterion_text":"- 19.\tHistory of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary embolism."}

Primary endpoints

• {"endpoint_text":"- \tProgression free survival (PFS) by local radiologist/investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1).","definition_or_measurement_approach":"PFS assessed by local radiologist/investigator per RECIST v1.1."}
• {"endpoint_text":"- For the safety lead-in phase only: \tIncidence of dose-limiting toxicity (DLTs) during 1 month.","definition_or_measurement_approach":"Incidence of DLTs during 1 month in the safety lead-in cohort."}

Secondary endpoints

• {"endpoint_text":"- \tIncidence and severity of AEs graded according to the NCI CTCAE v5.0 and changes in clinical laboratory parameters, vital signs and ECGs during the treatment until 30+/-2 days after EOT.","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v5.0; clinical labs, vital signs and ECGs monitored during treatment until 30 ± 2 days after end of treatment."}
• {"endpoint_text":"- \tIncidence of dose delays, dose modifications and discontinuations due to AEs.","definition_or_measurement_approach":"Recorded incidence of dose delays, modifications and treatment discontinuations attributable to adverse events."}
• {"endpoint_text":"- \tOverall Response Rate (ORR) per RECIST v1.1, defined as the number of patients achieving an overall best response of complete response (CR) or partial response (PR) divided by the total number of patients.","definition_or_measurement_approach":"ORR assessed per RECIST v1.1 as proportion of patients with best response CR or PR."}
• {"endpoint_text":"- \tTime to response, defined as the time from first dose to first radiographic evidence of response.","definition_or_measurement_approach":"Measured from first dose date to first radiographic evidence of response."}
• {"endpoint_text":"- \tDuration of Response (DOR), defined as the time from first radiographic evidence of response to the earliest documented disease progression or death due to underlying disease.","definition_or_measurement_approach":"Measured from first radiographic response to documented progression or death."}
• {"endpoint_text":"- \tOverall Survival (OS), defined as the time from first dose to death due to any cause.","definition_or_measurement_approach":"Measured from first dose to death from any cause."}
• {"endpoint_text":"- \tChange in PRO as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Patients (QLQ-C30) and Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C).","definition_or_measurement_approach":"Patient-reported outcomes measured using EORTC QLQ-C30 and FACT-C instruments."}

Spain

Earliest CTIS Part Ii Submission Date

22-01-2024

Latest Decision Or Authorization Date

31-10-2025

Processing Time Days

648

Number Of Sites

15

Number Of Participants

94

Primary sponsor

Full Name

Vall D Hebron Institute Of Oncology

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Distefar Del Sur S.L.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}