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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 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 46 participants.
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.
Interventions
- DRUG Abraxane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2008-12 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00583349
The ClinicalTrials.gov registry entry for NCT00583349 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Abraxane is the first listed.
NCT00583349 reports 0 study locations.
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.
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