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NCT00140140 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer
A Phase 1 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00140140: Clinical Trial Phase 1 study, sponsored by Celgene.
NCT00140140 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00140140, a Phase 1 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive disease may receive Herceptin, and 2) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the presence of planned growth factor support with G-CSF.
Primary Outcome
Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At le
Interventions
- DRUG Trastuzumab
- DRUG vinorelbine
- BIOLOGICAL G-CSF
- DRUG ABI-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
Why NCT00140140 stopped before completion
NCT00140140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT00140140 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00140140 about?
NCT00140140 is a clinical study titled "A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer". The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive disease may receive Hercepti...
What is the current status of trial NCT00140140?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2005-08. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00140140?
The interventions under investigation include: Trastuzumab (DRUG), vinorelbine (DRUG), G-CSF (BIOLOGICAL), ABI-007 (DRUG).
Who is sponsoring clinical trial NCT00140140?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00140140's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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