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

• Status: Completed
• Trial end date: 2020-08-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Capecitabine; Cisplatin; Fluorouracil; Ramucirumab

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:

• 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.