a study of ramucirumab (ly3009806) in combination with paclitaxel in participants with gastric cancer

Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

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.

Keywords: stomach cancer