MedTrace Logo

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

NCT00680901 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 545

Last updated 2025-08-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Neoplasms, Gastrointestinal Tract

Interventions

DRUG

Lapatinib

5 pills at 250mg each once daily

DRUG

Placebo

5 pills once daily

DRUG

Capecitabine

1700mg/m2/day in two daily doses

DRUG

Oxaliplatin

130mg/m2 on day 1

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-04
Primary Completion
2012-09-24
Completion
2024-10-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00680901 on ClinicalTrials.gov