Conditions: Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 645
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m\^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m\^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m\^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle. arm 2: Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m\^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m\^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m\^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.

Interventions: intervention 1: Ramucirumab intervention 2: Capecitabine intervention 3: Cisplatin intervention 4: Placebo intervention 5: Fluorouracil
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered orally intervention 3: Administered IV intervention 4: Administered IV intervention 5: Administered IV

Protocol document: