NCT02137343

A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction adenocarcinoma (GEJ).

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Rilotumumab	Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/SF/MET-driven activities in cells.
DRUG	Placebo	Placebo
DRUG	Cisplatin	A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
DRUG	Capecitabine	A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-05-13
• Last updated: 2016-04-04

Locations

25 sites across 2 countries: Japan, South Korea