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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine (NCT02898077)

The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab in participants with gastric and gastroesophageal cancer.
  • Drug: Ramucirumab
    Administered IV
    • LY3009806
  • Drug: Paclitaxel
    Administered IV
    • Drug: Placebo
      Administered IV
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers
      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).

      36 locations

      01 March, 2017
      02 November, 2017
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