A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Intervention: Ramucirumab; Capecitabine; Cisplatin; S-1; Oxaliplatin
Intervention description: Administered IV; Administered orally; Administered IV; Administered orally; Administered IV
Intervention MeSH terms: Capecitabine; Oxaliplatin; Ramucirumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      antitumor response of ramucirumab in combination with platinum/fluoropyrimidine regimens in
      Japanese participants with advanced gastric/gastrooesophageal junction cancer who have not
      received chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A histopathologically or cytologically confirmed diagnosis of gastric or
             gastroesophageal junction (GEJ) adenocarcinoma which is metastatic or locally advanced
             and unresectable. A participant with esophageal cancer is not eligible.

          -  Not have received prior first-line systemic chemotherapy for locally advanced and
             unresectable and/or metastatic disease. Participants whose disease has progressed
             after >6 months following the last dose of systemic treatment in the
             adjuvant/neoadjuvant setting are eligible.

          -  Measurable or nonmeasurable, but evaluable, disease, determined using guidelines in
             Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

          -  Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the time
             of enrollment.

          -  The participant has adequate organ function.

          -  Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria
             for Adverse Events (NCI CTCAE; version [v]4.03) of all clinically significant toxic
             effects of prior locoregional therapy, surgery, or other anticancer.

          -  Female participants of childbearing potential must have a negative serum or urinary
             pregnancy. Have an estimated life expectancy of ≥12 weeks in the judgment of the
             investigator.

        Exclusion Criteria:

          -  A significant bleeding disorder, vasculitis, or had a significant bleeding episode
             from the gastrointestinal tract within 12 weeks prior to enrollment.

          -  Uncontrolled arterial hypertension, despite standard medical management.

          -  A serious or nonhealing wound or peptic ulcer or bone fracture at enrollment.

          -  Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous
             access device (reservoir) placement within 7 days prior to enrollment.

          -  Radiation therapy within 14 days prior to enrollment.

          -  Received any previous systemic therapy (including investigational agents) targeting
             vascular endothelial growth factor (VEGF) or the VEGF receptor signaling pathways.

          -  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.

          -  A serious illness or medical condition(s).

          -  Pregnant or breastfeeding.

          -  Dysphagia for oral medication.

          -  Known allergy or hypersensitivity to any study treatment.

          -  Human epidermal growth factor receptor (HER) 2 status of positive.

          -  Received treatment within 28 days of the initial dose of study drug with an
             investigational product or non-approved use of a drug or device.