A Study to Assess the Pharmacokinetics of Ramucirumab (IMC-1121B) in Combination With FOLFIRI

Exclusion Criteria

• •Has received a therapeutic monoclonal antibody within the last 42 days
• •Has received cytotoxic chemotherapy within the last 21 days
• •Has received radiotherapy within the last 14 days
• •Are currently enrolled in, or discontinued within the last 14 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• •Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the last 3 months
• •Has an uncontrolled illness, including, but not limited to uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
• •Has experienced any arterial thromboembolic event within the last 6 months
• •Has known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression
• •Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
• •Has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
• •Has received a prior organ or transplantation
• •Has undergone major surgery within the last 28 days
• •Has had a serious nonhealing wound, ulcer, or bone fracture within the last 28 days
• •Has an elective or planned major surgery to be performed during the course of the trial
• •Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
• •Has experienced a Grade 3 or higher bleeding event within the last 3 months
• •Has a known history or clinical evidence of Gilbert's Syndrome, or is known to have any of the following genotypes: uridine diphosphate glucuronosyltransferase isoform 1A1 (UGT1A1)\*6/\*6, UGT1A1\*28/\*28, or UGT1A1\*6/\*28
• •Has received clinically relevant inhibitors or inducers of cytochrome P (CYP) 450 CYP3A4/5 or CYP2C9 and/or isoenzymes within the last 3 weeks
• •Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis