EMD 525797 in combination with Cetuximab and Irinotecan in k-ras Wildtype Metastatic Colorectal Cancer

• Conditions: Subjects with k-ras WT, metastatic colorectal cancer who have failed a fist line chemotherapy with an oxaliplatin-containing regimen will be eligible for this trial.; MedDRA version: 17.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-012040-16-BG
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-26
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Signed and dated written informed consent prior to any specific trial procedure and the ability to comply with the trial and follow-up procedures;
• Age =18 years of male or female gender;
• Subjects with histologically-confirmed k-ras WT CRC with documented distant metastasis;
• Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease;
• Failed an oxaliplatin regimen for metastatic disease. Failure is defined as either PD (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen, or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing
retreatment;
• At least 1 radiographically documented measurable lesion in a previously non-irradiated area according to RECIST (Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as
=2 cm by conventional techniques or =1 cm by spiral CT scan;
• ECOG performance status 0-1, or KPS =80%;
• Acceptable laboratory parameters including ANC
=1.5 x 10E9/L, platelets =100 x 109/L, hemoglobin =9 g/dL (without transfusions), bilirubin =1.5 x ULN, ASAT =5 x ULN, ALAT =5 x ULN, serum creatinine =1.25 x ULN and/or creatinine clearance =50 ml/min, PT, INR, and PTT within normal limits and sodium and potassium within normal limits or =10% above or below
(supplementation permitted);
• Effective contraception for both male and female subjects if the risk of conception exists.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

• Treatment in another clinical trial within the past 30 days or previous treatment with any inhibitor of EGFR;
• Known brain metastasis and/or leptomeningeal disease;
• Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any investigational drug in the 30 days before the start of trial treatment entry, planned major surgery during the trial;
• Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol (except for physiologic replacement; steroids up to 10 mg of prednisone equivalent or topical and inhaled steroids are allowed);
• Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), or clinically relevant cardiomyopathy;
• Uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg under resting conditions;
• History of myocardial infarction in the last 12 months, or a high risk of uncontrolled
arrhythmia, coagulation disorder associated with bleeding or recurrent thrombotic events, recent peptic ulcer disease (endoscopically proven) within 6 months of trial treatment start, chronic inflammatory bowel disease, or acute/chronic ileus;
• Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection;
• Presence of any contra-indications or known hypersensitivity to treatment with EMD 525797, cetuximab, and irinotecan, or to any of the excipients of these drugs;
• Pregnancy or lactation period;
• Concurrent treatment with a non-permitted drug;
• Previous malignancy other than CRC in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix;
• Medical or psychological conditions that would not permit the subject to complete the trial or sign informed consent;
• Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who are suffering or have suffered from such;
• Legal incapacity or limited legal capacity;
• Significant disease which, in the Investigator’s opinion, would exclude the subject from the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified