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Clinical Trials/EUCTR2005-001362-14-BE
EUCTR2005-001362-14-BEActive, not recruitingNot Applicable

Open-label, single-arm, multicenter phase II study of matuzumab in combination with irinotecan background chemotherapy in subjects with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer that developed progressive disease while on therapy or within 4 weeks after termination of an irinotecan based regimen. - MAURICE

Merck KGaA0 sites46 target enrollmentStarted: September 2, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Merck KGaA
Enrollment
46
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 last irinotecan treatment 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

  • •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

Investigators

Sponsor
Merck KGaA

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