A Study of Ramucirumab in Treating Japanese Participants With Metastatic Gastric or Gastroesophageal Junction Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Ramucirumab
Intervention description: Administered IV
Intervention MeSH terms: Ramucirumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate progression-free survival in participants with
      gastric or gastroesophageal junction cancer who have had disease progression following
      first-line therapy who undergo treatment with ramucirumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed gastric carcinoma, including gastric
             adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma

          -  Metastatic disease or locally recurrent, unresectable disease

          -  Measurable disease and/or evaluable disease

          -  Experienced disease progression during or within 4 months after the last dose of
             first-line therapy for metastatic disease, or during or within 6 months after the last
             dose of adjuvant therapy

          -  Life expectancy of at least 3 months

          -  Resolution to Grade less than or equal to 1 by the National Cancer Institute Common
             Terminology Criteria for Adverse , Version 4.03, of all clinically significant toxic
             effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy

          -  Eastern Cooperative Oncology Group performance status score of 0-1

          -  Has adequate organ function

          -  Must be postmenopausal, surgically sterile, or using effective contraception (hormonal
             or barrier methods), if sexually active

          -  Female participants of childbearing potential must have a negative serum or urine
             pregnancy test within 7 days prior to enrollment

        Exclusion Criteria:

          -  Documented and/or symptomatic brain or leptomeningeal metastases

          -  Bone metastases

          -  Experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to
             enrollment

          -  Experienced any arterial thromboembolic event within 6 months prior to enrollment

          -  Ongoing or active significant infection, symptomatic congestive heart failure (CHF),
             unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia,
             uncontrolled thromboembolic or hemorrhagic disorder, or any other serious uncontrolled
             medical disorders in the opinion of the investigator

          -  Ongoing or active psychiatric illness or social situation that would limit compliance
             with study requirements

          -  Blood pressure in abnormal range despite standard medical management

          -  Has a serious or nonhealing wound, ulcer, or bone fracture

          -  Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric
             cancer

          -  Received any investigational therapy within 30 days prior to enrollment

          -  Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous
             access device placement within 7 days prior to enrollment

          -  Received prior therapy with an agent that directly inhibits vascular endothelial
             growth factor (VEGF) or vascular endothelial growth factor receptor 2 (VEGFR-2)
             activity (including bevacizumab), or any anti-angiogenic agent

          -  Receiving chronic therapy with nonsteroidal anti-inflammatory drugs or receiving other
             antiplatelet agents. Aspirin use at doses up to 325 milligrams per day is permitted

          -  Has elective or planned major surgery to be performed during the course of the
             clinical study

          -  Has a known allergy to any of the treatment components

          -  Pregnant or breastfeeding

          -  Have positive test results for human immunodeficiency virus, hepatitis B, or hepatitis
             C antibodies

          -  Known alcohol or drug dependency

          -  Previous or concurrent malignancy except for basal or squamous cell skin cancer
             (nonmelanoma) and/or pre-invasive carcinoma of the cervix, mucosal gastrointestinal or
             uterine carcinoma, or other solid tumors treated curatively and without evidence of
             recurrence for at least 3 years prior to enrollment

          -  Currently enrolled in a clinical trial involving an investigational product or
             non-approved use of a drug or device (other than the study drug/device used in this
             study), or concurrently enrolled in any other type of medical research judged not to
             be scientifically or medically compatible with this study