A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer
Condition: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: Ramucirumab; Paclitaxel
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Paclitaxel; Ramucirumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stomach cancer

Summary:

      The main purpose of this study is to evaluate the efficacy of an alternative dose of
      ramucirumab in combination with paclitaxel in participants with second-line metastatic or
      locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has a diagnosis of gastric or GEJ adenocarcinoma.

          -  The participant has disease progression during or within 4 months after last dose of
             first-line chemotherapy or during or within 6 months after the last dose of
             neoadjuvant or adjuvant therapy.

          -  The participant received combination chemotherapy, which must include a platinum
             and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.

          -  The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors
             1.1.

          -  The participant has an Eastern Cooperative Oncology Group performance status of 0 or
             1.

          -  The participant has adequate organ function:

               -  Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine
                  aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the
                  liver has tumor involvement, AST and ALT <5 × ULN.

               -  Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50
                  milliliters/minute.

               -  Urinary protein is <2+.

               -  Absolute neutrophil count ≥1.5 × 10^9/liter (L), platelets ≥100 × 10^9/L, and
                  hemoglobin ≥9 grams/deciliter (5.58 millimoles/L).

               -  International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5
                  seconds above ULN.

          -  The participant has an estimated life expectancy of minimum 12 weeks.

          -  The participant has resolution to Grade 1 or less by Common Terminology Criteria for
             Adverse Events Version 4.0, of all clinically significant toxic effects of previous
             therapy.

          -  The participant, if male, is sterile or agrees to use a reliable method of birth
             control.

          -  The participant, if female, is surgically sterile, is postmenopausal, or agrees to use
             a highly effective method of birth control.

          -  The participant, if female and of child-bearing potential, must have a negative
             pregnancy test.

        Exclusion Criteria:

          -  The participant is receiving therapy with any of the following:

               -  Nonsteroidal anti-inflammatory agents.

               -  Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is
                  permitted.

          -  The participant received radiotherapy within 14 days prior to randomization.

          -  The participant received previous chemotherapy with a cumulative dose of >900 mg per
             meter squared (mg/m^2) of epirubicin or >400 mg/m^2 of doxorubicin.

          -  The participant has documented brain metastases or leptomeningeal disease.

          -  The participant has a significant bleeding disorder or vasculitis.

          -  The participant experienced any arterial thromboembolic event within 6 months.

          -  The participant has symptomatic congestive heart failure or symptomatic cardiac
             arrhythmia.

          -  The participant has uncontrolled hypertension, despite antihypertensive intervention.

          -  The participant underwent major surgery within 28 days.

          -  The participant has a history of gastrointestinal perforation or fistula within 6
             months.

          -  The participant has a history of inflammatory bowel disease or Crohn's disease
             requiring medical intervention within 12 months.

          -  The participant has bowel obstruction or history of chronic diarrhea that is
             considered clinically significant.

          -  The participant has either of the following:

               -  Child-pugh B or C cirrhosis.

          -  The participant has a serious illness or medical condition including:

               -  Human immunodeficiency virus infection.

          -  The participant has a concurrent active malignancy other than the following:

               -  Nonmelanomatous skin cancer.

               -  In situ carcinoma of the cervix or other noninvasive carcinoma or in situ
                  neoplasm.

          -  The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone
             fracture.

          -  The participant experienced any Grade 3 or 4 venous thromboembolic event that is not
             adequately treated.