A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer
Condition: Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: Ramucirumab; Paclitaxel; Placebo
Intervention description: Administered IV; Administered IV; Administered IV
Intervention MeSH terms: Paclitaxel; Ramucirumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Second line; Angiogenesis; Vascular endothelial growth factor receptor 2

Summary:

      The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab
      in participants with gastric and gastroesophageal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 or 1 at
             study entry.

          -  Have a histopathologically or cytologically confirmed diagnosis of gastric or
             gastroesophageal junction (GEJ) adenocarcinoma.

          -  Have metastatic disease or locally advanced, unresectable disease.

          -  Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid
             Tumors (RECIST), Version 1.1.

          -  Have experienced documented objective radiographic or symptomatic disease progression
             during first-line therapy, or within 4 months after the last dose of first-line
             therapy with any platinum/fluoropyrimidine doublet for unresectable or metastatic
             disease.

          -  Have adequate organ function.

          -  Have urinary protein ≤1+ on dipstick or routine urinalysis.

        Exclusion Criteria:

          -  Have undergone major surgery within 28 days prior to randomization.

          -  Have received any first-line chemotherapy other than platinum and fluoropyrimidine
             with or without anthracycline for advanced gastric or GEJ adenocarcinoma.

          -  Have received any previous systemic therapy (including investigational agents)
             targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signaling
             pathways.

          -  Have a history of deep vein thrombosis, pulmonary embolism, or any other significant
             thromboembolism during the 3 months prior to randomization.

          -  Have significant bleeding disorders, vasculitis, or had a significant bleeding episode
             from the gastrointestinal (GI) tract within 3 months prior to study entry.

          -  Have a history of GI perforation and/or fistulae within 6 months prior to
             randomization.

          -  Have experienced any arterial thromboembolic event within 6 months prior to
             randomization.

          -  Have uncontrolled arterial hypertension (systolic blood pressure ≥160 millimeters of
             mercury [mmHg] or diastolic blood pressure ≥100 mmHg) despite standard medical
             management.

          -  Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days
             prior to randomization.

          -  Have a serious illness or medical condition(s).