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

Inclusion Criteria:

- The participant has histologically or cytologically confirmed gastric carcinoma,
including gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma.
(Participants with adenocarcinoma of the distal esophagus are eligible if the primary
tumor involves the GEJ)

- 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

Exclusion Criteria:

- The participant has documented and/or symptomatic brain or leptomeningeal metastases

- The participant has experienced any Grade 3 to 4 gastrointestinal (GI) bleeding
within 3 months prior to enrollment

- The participant has experienced any arterial thromboembolic events, including but not
limited to myocardial infarction, transient ischemic attack, cerebrovascular
accident, or unstable angina, within 6 months prior to enrollment

- The participant has an ongoing or active infection, symptomatic congestive heart
failure, unstable angina pectoris, symptomatic or poorly controlled cardiac
arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious
uncontrolled medical disorders in the opinion of the treating physician

- The participant has ongoing or active psychiatric illness or social situation that
would limit compliance with treatment

- The participant has uncontrolled or poorly controlled hypertension [>160 milliliter
of mercury (mmHg) systolic or >100 mmHg diastolic for >4 weeks] despite standard
medical management

- The participant has a serious or nonhealing wound, ulcer, or bone fracture within 28
days prior to enrollment

- The participant has received chemotherapy, radiotherapy, immunotherapy, or targeted
therapy for gastric cancer within 2 weeks prior to enrollment

- The participant has received any investigational therapy within 30 days prior to
enrollment

- The participant has undergone major surgery within 28 days prior to enrollment, or
subcutaneous venous access device placement within 7 days prior to enrollment

- The participant has received prior therapy with an agent that directly inhibits
vascular endothelial growth factor (VEGF) (including bevacizumab), or vascular
endothelial growth factor receptor-2 (VEGFR-2) activity, or any antiangiogenic agent

- The participant is receiving chronic antiplatelet therapy, including aspirin,
nonsteroidal anti-inflammatory drugs (NSAIDs; including ibuprofen, naproxen, and
others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use
(maximum dose 325 mg/day) is permitted

- The participant has elective or planned major surgery to be performed during the
course of the clinical trial

- The participant has a known allergy to any of the treatment components

- The participant is pregnant or breastfeeding

- The participant is known to be positive for infection with the human immunodeficiency
virus (HIV)

- The participant has known alcohol or drug dependency

- The participant has a concurrent active malignancy other than adequately treated
nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm

- The participant has a known hypersensitivity to ramucirumab or any of the excipients

- The patient may not have received more than 1 prior therapy in the metastatic
setting.