Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas
Condition: Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Ramucirumab (IMC-1121B ); Paclitaxel
Intervention description: 8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle; 80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle
Intervention MeSH terms: Paclitaxel; Ramucirumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Adenocarcinoma; Gastroesophageal Junction

Summary:

      Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in
      combination with paclitaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a histopathologically or cytologically confirmed diagnosis of gastric or
             gastroesophageal junction (GEJ) adenocarcinoma

          -  Has an advanced or metastatic solid gastric adenocarcinoma that has failed standard
             therapy

          -  Has resolution of all clinically significant toxic effects of prior therapy, surgery,
             treatment with an investigational agent or device, treatment monoclonal antibody or
             small molecule, and radiotherapy or chemotherapy.

          -  Has adequate organ function

          -  Eligible participants of reproductive potential (both sexes) agree to use adequate
             contraceptive methods (hormonal or barrier methods) during the study period and for 12
             weeks after the last dose of study medication

        Exclusion Criteria:

          -  Has undergone major surgery within 28 days prior to the study, or subcutaneous venous
             access device placement within 7 days prior to the study registration date

          -  Has elective or planned surgery to be conducted during the trial

          -  Has had treatment with an investigational agent or device, an antineoplastic small
             molecule, or antineoplastic radiotherapy or chemotherapy

          -  Was previously treated with a chemotherapy regimen containing nitrosoureas or
             mitomycin C

          -  Has had treatment with an antineoplastic monoclonal antibody within 8 weeks prior to
             the study registration date

          -  Has a history of deep vein thrombosis, pulmonary embolism, or any other significant
             thromboembolism prior to the study registration date

          -  Has experienced any arterial thrombotic event, including myocardial infarction,
             cerebrovascular accident, or transient ischemic attack, within 6 months prior to the
             study date

          -  Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin
             or similar agents. (Participants receiving prophylactic, low-dose anticoagulation
             therapy are eligible provided that the coagulation parameters International Normalized
             Ratio (INR) ≤ 1.5, prothrombin time (PT) and partial thromboplastin time (PTT) or - Is
             receiving chronic therapy with nonsteroidal anti-inflammatory agents [Aspirin use at
             doses up to 325 milligrams/day (mg/day) is permitted]

          -  Has significant bleeding disorders, vasculitis, history of postoperative bleeding
             complications, hemoptysis or had a significant bleeding episode from the
             gastrointestinal (GI) tract within 3 months prior to the study date

          -  Has a history of GI perforation and/or fistulae within 6 months prior to the study
             date

          -  Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or
             poorly controlled cardiac arrhythmia

          -  Has uncontrolled arterial hypertension despite standard medical management.

          -  Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days
             prior to the study date

          -  Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive
             intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea

          -  Has a serious illness or medical condition(s)

          -  Is pregnant or lactating

          -  Has received treatment with another investigational drug or participation in another
             interventional clinical trial within 28 days prior to the study date