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NCT00312377 · ClinicalTrials.gov registry record · Phase 3
ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,690
- Enrollment target
NCT00312377: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT00312377 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 1,690 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (119% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00312377, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,690 participants
- Enrollment target
Study Summary
This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy. This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone. All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer. In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent. Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients. Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.
Primary Outcome
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
Interventions
- DRUG Docetaxel
- DRUG Vandetanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,690 participants |
| Start Date | 2006-05 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT00312377 record still lists
NCT00312377 is an interventional study that assigns participants to a tested intervention. Its 1,690 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (119% higher).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT00312377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00312377 about?
NCT00312377 is a clinical study titled "ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer". This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and...
What is the current status of trial NCT00312377?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,690 participants. The study started on 2006-05. Estimated completion is 2014-03.
What interventions are being tested in trial NCT00312377?
The interventions under investigation include: Docetaxel (DRUG), Vandetanib (DRUG).
Who is sponsoring clinical trial NCT00312377?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00312377's enrollment target sits among peer trials
1,690 134th of 2000 higher than 1,867 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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