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NCT00627978 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00627978: Completed Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT00627978 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00627978, a Phase 2 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Primary Objectives * Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy * Detailed characterization of peripheral neuropathy in patients who receive ixabepilone Secondary Objectives * Clinical benefit rate * Time to progression ( TTP) * Toxicity * Exploratory studies: * Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic changes observed in neurons. * Relation of NGF, IL8, and IL10 to the development of clinical symptoms and ultrastructural changes in neurons.
Primary Outcome
Digital photographs for morphometry were captured at a magnification of 8000-16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.
Interventions
- DRUG ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT00627978 record still lists
NCT00627978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which ixabepilone is the first listed.
NCT00627978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00627978 about?
NCT00627978 is a clinical study titled "Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons". Primary Objectives * Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy * Detailed characterization of peripheral neuropathy in patients who receive ixabepilone Secondary Objectives * Clinical benefit rate * Time to progression ( TTP) * Toxi...
What is the current status of trial NCT00627978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2007-11. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00627978?
The interventions under investigation include: ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00627978?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00627978's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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