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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 545 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00680901
The ClinicalTrials.gov registry entry for NCT00680901 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 545 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00680901 reports 0 study locations.
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.
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