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NCT00680901 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 545
- Enrollment target
NCT00680901: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00680901 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 545 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00680901, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 545 participants
- Enrollment target
Study 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.
Primary Outcome
Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing.
Interventions
- DRUG Placebo
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 545 participants |
| Start Date | 2008-06-04 |
| Est. Completion | 2024-10-03 |
| Phase | Phase 3 |
What the finished NCT00680901 record still lists
NCT00680901 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00680901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00680901 about?
NCT00680901 is a clinical study titled "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". 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 chemot...
What is the current status of trial NCT00680901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 545 participants. The study started on 2008-06-04. Estimated completion is 2024-10-03.
What interventions are being tested in trial NCT00680901?
The interventions under investigation include: Placebo (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00680901?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00680901's enrollment target sits among peer trials
545 689th of 2000 higher than 1,310 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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