Epidermal Growth Factor Receptor (EGFR) expressing, metastatic colorectal cancer MedDRA version: 7.1 Level: LLT Classification code 10052362
Conditions
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent provided prior to any prescreening procedure 2.Male or female, 18 years or older 3.Inpatient / Outpatient 4.ECOG performance status of = 2 at study entry 5.Histologically confirmed adenocarcinoma of the colon or rectum 6.Metastatic disease 7.Tissue available for EGFR testing and immunohistochemical evidence of tumor EGFR (HER 1) expression 8.At least 1 bidimensional measurable lesion (not in an irradiated area) according to the modified WHO criteria 9.An irinotecan containing regimen as most recent chemotherapy treatment for at least 6 weeks 10. Documented progression by comparison of CT or MRI scans on irinotecan based therapy whereby the time between documentation of progression and the end of last irinotecan treatment cycle should not be longer than 4 weeks 11.Last application of prior antitumor therapy = 4 12.Time period from documentation of PD to start of study treatment = 12 weeks 13.Adequate liver, bone marrow, and renal function, defined as:· Bilirubin = 1.5´upper reference range· Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) = 2.5´ULN (for subjects with liver metastases ALT/AST = 5 ´ ULN)· Neutrophils > 1500 mm3· Platelets > 100,000/µL· Hemoglobin > 10 g/dL· Serum creatinine = 1.5 x ULN or glomerular filtration rate of > 60 mL/minute 14.Recovery from relevant toxicity to previous treatment before study entry 15.Willingness to use contraceptive method for the study duration and 2 months post-dosing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Previous exposure to epidermal growth factor targeting or epidermal growth factor signaling therapy 2.Previous exposure to VEGF targeting or VEGF-signaling therapy 3.Radiotherapy or major surgery within the last 30 days prior to the start of study treatment 4.Documented or symptomatic brain metastases and/ or central nervous system metastases or leptomeningeal disease 5.Concurrent malignancies or invasive cancers diagnosed within the past 5 years, except for adequately treated basal cell cancer of the skin or in situ cancer of the cervix 6.Known hypersensitivity to matuzumab or irinotecan (according to the current investigators’ brochure for matuzumab and the relevant product information sheets for irinotecan) 7.History of acute or sub-acute intestinal occlusion or history of inflammatory bowel disease 8.Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias 9.Clinically significant abnormal electrocardiogram (ECG) or cardiac history (e.g. subjects with myocardial infarction within the last 6 months) 10.Significant disease which, in the Investigator’s opinion, would exclude the subject from the study 11.Subject requires concurrent treatment with anon-permitted drug 12.Participation in another clinical study within 30 days before first study treatment 13.Pregnancy (absence to be confirmed by serum ß-hCG test) or lactation period 14.Known alcohol or drug abuse 15.Legal incapacity or limited legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the response rate of matuzumab in combination with irinotecan background chemotherapy for EGFR-expressing metastatic colorectal cancer which developed PD while on therapy or within 4 weeks after termination of therapy with an irinotecan-based regimen. ;Secondary Objective: Progression free survival Duration of response Overall survival time Safety evaluation Determination of HAHA Pharmacokinetics of matuzumab.;Primary end point(s): Determination of the response rate by the same imaging technique (CT/MRI) that is used consistently within each subject. Evaluation by investigator and classification by modified WHO criteria. | — |
Countries
Austria, Belgium, Germany
Outcome results
None listed