CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 545 enrolled
Drug / intervention
Lapatinib +3 moredrug
Likely dose
Lapatinib 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00680901
NCT00680901Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted May 20, 2008·Updated Aug 7, 2025

In Brief

A Phase 3 clinical trial evaluating Lapatinib, Placebo, and 2 other interventions for Neoplasms, Gastrointestinal Tract. Completed, enrolled 545 participants across 183 sites in 23 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Gastrointestinal Tract
CountriesArgentina, Brazil, Canada, Chile, China, Estonia, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Peru, Poland, Puerto Rico, Russia, South Korea, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2008
Enrollment StartJun 4, 2008
Primary CompletionSep 24, 2012
Study CompletionOct 3, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.1 years ago

Interventions

Lapatinibdrug

5 pills at 250mg each once daily

Placebodrug

5 pills once daily

Capecitabinedrug

1700mg/m2/day in two daily doses

Oxaliplatindrug

130mg/m2 on day 1