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Keep this study
Lead
Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects with histologically confirmed kras wildtype (WT) colorectal carcinoma (CRC) with documented distant metastasis
Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease
Failed an oxaliplatin regimen for metastatic colorectal carcinoma (mCRC). Failure is defined as either progressive disease (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 Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as greater than or equal to (\>=) 2 centimeter (cm) by conventional techniques or \>=1 cm by spiral computed tomography (CT) scan
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or Karnofsky performance status (KPS) \>= 80 percent (%)
Absolute Neutrophil Count (ANC) \>=1.5 x 10\^9/Liter
Platelets \>=100 x 10\^9/Liter
Hemoglobin \>=9 gram per deciliter (g/dL) (without transfusions)
Bilirubin less than or equal to (\<=) 1.5 x upper limit normal (ULN)
Aspartate transaminase (AST) \<=5 x ULN and alanine transaminase (ALT) \<=5 x ULN
Serum creatinine \<=1.25 x ULN and/or creatinine clearance \>=50 milliliter per minute (mL/min)
International Nationalized Ratio (INR), and partial thromboplastin time (PTT) within normal limits
Sodium and potassium within normal limits or \<=10% above or below (supplementation permitted)
You may not be if
Previous treatment with any inhibitor of Epidermal Growth Factor Receptor (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), clinically relevant cardiomyopathy, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
Uncontrolled hypertension defined as systolic blood pressure \>=160 millimeter of mercury (mmHg) and/or diastolic blood pressure \>=100 mmHg under resting conditions
History of coagulation disorder associated with bleeding or recurrent thrombotic events
History of recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) 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
Clareo Health | EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer
