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
Completed · Phase 3 · Has a placebo group
Conditions studied: Neoplasms, Gastrointestinal Tract
In brief
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.
Key facts
- Study ID
- NCT00680901
- Run by
- Novartis Pharmaceuticals
- People needed
- 545
- Starts
- 2008-06-04
- Expected to finish
- 2024-10-03
- Last updated by the study team
- 2025-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Fullerton, California, United States
- Novartis Investigative Site — La Verne, California, United States
- Novartis Investigative Site — Northridge, California, United States
- Novartis Investigative Site — Oxnard, California, United States
- Novartis Investigative Site — Redondo Beach, California, United States
- Novartis Investigative Site — Santa Maria, California, United States
- Novartis Investigative Site — Santa Monica, California, United States
- Novartis Investigative Site — Terre Haute, Indiana, United States
- Novartis Investigative Site — Henderson, Nevada, United States
- Novartis Investigative Site — Ciudad Aut6noma de Buenos Aires, Buenos Aires, Argentina
- Novartis Investigative Site — Quilmes, Buenos Aires, Argentina
- Novartis Investigative Site — Neuquén, Neuquén Province, Argentina
- Novartis Investigative Site — Cipolletti, Río Negro Province, Argentina
- Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
- Novartis Investigative Site — Buenos Aires, Argentina
- Novartis Investigative Site — La Rioja, Argentina
- Novartis Investigative Site — San Miguel de Tucumán, Argentina
- Novartis Investigative Site — Santa Fe, Argentina
- Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil
- Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
- Novartis Investigative Site — Florianópolis, Santa Catarina, Brazil
- Novartis Investigative Site — Barretos, São Paulo, Brazil
- Novartis Investigative Site — Alhambra, California, United States
Full record on ClinicalTrials.gov
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