A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

In brief

The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

Key facts

Study ID

NCT02314117

Run by

Eli Lilly and Company

People needed

645

Starts

2015-01-20

Expected to finish

2020-08-14

Last updated by the study team

2021-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• St Jude Medical Center — Fullerton, California, United States
• SMO TRIO -Translational Research — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Cancer Care Associates Medical Group — Redondo Beach, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• Central Coast Medical Oncology Corporation — Santa Monica, California, United States
• University of Colorado School of Medicine — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Holy Cross Hospital Inc. — Fort Lauderdale, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists and Research Institute — St. Petersburg, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Illinois CancerCare — Peoria, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Weill Cornell Medical College — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Oncology Hematology Care Inc — Cincinnati, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• SMO Sarah Cannon Research Inst. — Nashville, Tennessee, United States
• Tennessee Oncology PLLC — Nashville, Tennessee, United States
• UT Southwestern Med Ctr — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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