A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2011
INTERVENTION: investigational material(s) Generic name etc : Ramucirumab DP(IMC‐1121B) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Ramucirumab DP and Paclitaxel control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Placebo and Paclitaxel CONDITION: Gastric Cancer INCLUSION CRITERIA: ‐Signed informed consent ‐Histologically or cytologically confirmed Gastric or gastroesophageal junction adenocarcinoma ‐Metastatic disease or locally advanced , unresectable disease ‐Disease progression during or within 4 months after the last dose of the first‐line therapy (platinum/fluoropyrimidine doublet with or without anthracycline) ‐Organs are functioning well (liver, kidney, blood) ‐Good performance status (ECOG 0 to 1)
Epistemonikos ID: f45960a1e61bd6edb26db1f2f01b9365c385c469
First added on: Aug 26, 2024