Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
investigational material(s)
Generic name etc : Ramucirumab+Cisplatin+Capecitabine
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration fo
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible. -Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after >12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible. -Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1). Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed. -Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at baseline. -Have adequate organ function. -Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency). -Have an estimated life expectancy of >= 12 weeks in the judgment of the investigator.
Exclusion criteria
Exclusion criteria: -Participants with adenocarcinoma of the esophagus are excluded. -Participants with human epidermal growth factor receptor 2 (HER2)-positive status. -Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents. -Have radiation therapy within 14 days prior to randomization. -Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression. -Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to randomization. -Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization. -Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia. -Have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention. -Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter [PICC] line) and the investigator does not anticipate any significant bleeding. -Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization. -Have a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) >= 12 months prior to randomization. -Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator. -The participant has: cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis. -Have known allergy or hypersensitivity to any components of study treatment. -Are pregnant or lactating
Outcome results
None listed