LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

Neoplasms, Gastrointestinal Tract Clinical Trial

Official title: A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib

Status Active, not recruiting

Clinical Trial Summary

This is an international multi-center trial that will enroll patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extends the time to progression and overall survival. Tumor ErbB2 (HER2) status must be known before trial entry. CapeOx is administered to all patients, and patients will be randomly assigned to receive either lapatinib or placebo.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms, Gastrointestinal Tract

• NCT number: NCT00680901
• Study type: Interventional
• Source: Novartis
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 4, 2008
• Completion date: January 22, 2025