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NCT00583349 · ClinicalTrials.gov registry record · Phase 1
Intravesicular Abraxane for Treatment-Refractory Bladder Cancer
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT00583349: Completed Phase 1 study, sponsored by Columbia University.
NCT00583349 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00583349, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
Phase I: To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose. To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau and Ki67. Phase II: To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory non-muscle invasive and a subset of T2 TCC of the bladder as measured by response rate (defined as negative cytology and bladder biopsy). To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.
Primary Outcome
To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose (MTD). A DLT is defined by the National Cancer Institute Common Toxicity Criteria version 3.0
Interventions
- DRUG Abraxane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2008-12 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT00583349 record still lists
NCT00583349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which Abraxane is the first listed.
NCT00583349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00583349 about?
NCT00583349 is a clinical study titled "Intravesicular Abraxane for Treatment-Refractory Bladder Cancer". Phase I: To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose. To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau...
What is the current status of trial NCT00583349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2008-12. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00583349?
The interventions under investigation include: Abraxane (DRUG).
Who is sponsoring clinical trial NCT00583349?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00583349's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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