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NCT00251433 · ClinicalTrials.gov registry record · Phase 1
GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT00251433: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT00251433 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00251433, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab.
Interventions
- DRUG lapatinib, docetaxel, trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2005-09-26 |
| Est. Completion | 2022-06-22 |
| Phase | Phase 1 |
Why NCT00251433 stopped before completion
NCT00251433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 1 intervention - of which lapatinib, docetaxel, trastuzumab is the first listed.
NCT00251433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00251433 about?
NCT00251433 is a clinical study titled "GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer". This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three dr...
What is the current status of trial NCT00251433?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2005-09-26. Estimated completion is 2022-06-22.
What interventions are being tested in trial NCT00251433?
The interventions under investigation include: lapatinib, docetaxel, trastuzumab (DRUG).
Who is sponsoring clinical trial NCT00251433?
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 NCT00251433's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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