International Expanded Access Program to Provide Ramucirumab for the Treatment of Metastatic Gastric Cancer

Inclusion Criteria

• •The participant has metastatic disease or locally recurrent, unresectable disease
• •The participant has measureable or evaluable disease as determined by standard computed tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
• •The participant has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy for metastatic disease, or during treatment, or within 6 months after the last dose of adjuvant therapy
• •o Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum and/or fluoropyrimidine components. Regimens including a third agent, such as an anthracycline or a taxane, are acceptable provided a fluoropyrimidine and/or a platinum were used.
• •The participant has resolution to Grade ≤1 (or to Grade ≤2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)
• •The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
• •The participant has adequate hepatic function
• •The participant does not have:
• •* cirrhosis at a level of Child-Pugh B (or worse) or
• •* cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
• •The participant has adequate renal function as defined by a serum creatinine ≤1.5 times the upper limit of normal (ULN), or creatinine clearance (measured via 24-hour urine collection) ≥40 milliliter per minute (mL/minute)
• •The participant's urinary protein is ≤1+ on dipstick or routine urinalysis (UA)
• •The participant has adequate hematologic function
• •The participant must have adequate coagulation function
• •If the participant has received prior anthracycline therapy as part of his or her first-line regimen, the participant is able to engage in ordinary physical activity without significant fatigue or dyspnea (equivalent to New York Heart Association Class I function)
• •Because the teratogenicity of ramucirumab is not known, the participant, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
• •Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment