Metastatic Disease Clinical Trial
Official title:
Nintedanib Plus mFOLFOX6 for Previously Untreated Metastatic Esophagogastric Adenocarcinoma (MEGAN): A Randomized, Placebo-controlled, Triple-blind Phase II Study
This is a prospective, multicenter, randomized, placebo-controlled, triple-blind phase II
trial. The randomization will be a 1:1 randomization (experimental arm:control arm). This
study will enroll patients with histologically confirmed esophagogastric adenocarcinoma with
metastatic disease. Patients will have had no previous chemotherapy for metastatic
esophagogastric cancer. Patients will receive nintedanib or placebo in combination with
mFOLFOX6 (5-Fluorouracil 400 mg/m2 bolus on day 1, 5-Fluorouracil 2400 mg/m2 continuous
infusion over 46 hours starting on day 1, Leucovorin 400 mg/m2 on day 1, Oxaliplatin 85
mg/m2 on day 1) via IV infusions every 2 weeks (14 days). Dose modification of nintedanib or
placebo and mFOLFOX6 is allowed. Patients may continue to receive protocol therapy as long
as they have not experienced any adverse events requiring permanent discontinuation of study
medication and have not demonstrated disease progression.
The primary objective is to test the hypothesis that progression free survival (PFS) is
prolonged in HER2-negative patients with untreated metastatic esophagogastric adenocarcinoma
when treated with nintedanib plus modified FOLFOX6 (mFOLFOX6) as compared to placebo plus
mFOLFOX6. The analyses will be performed when 124 events for PFS will have been observed in
the pooled arms.
n/a
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