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NCT00479765 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma
A Phase 1 study, sponsored by Boston Scientific Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00479765 is a Phase 1 study that was terminated before completion, run by Boston Scientific Corporation. The registered enrollment target is 4 participants.
The verdict
NCT00479765, a Phase 1 study, was terminated before completion, sponsored by Boston Scientific Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel. The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed into the tumor resection cavity in the brain following surgical removal of the tumor. Dose escalation is conducted by gradually increasing the amount of OncoGel placed in the resection cavity in small groups of patients, and watching the patients closely for side effects before moving to the next dose level. The study will also test whether OncoGel helps to prevent or delay the tumor from regrowing.
Interventions
- DRUG OncoGel (ReGel/Paclitaxel)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00479765
The ClinicalTrials.gov registry entry for NCT00479765 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OncoGel (ReGel/Paclitaxel) is the first listed.
NCT00479765 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00479765 about?
NCT00479765 is a clinical study titled "A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma". OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel. The purpose of this study is to...
What is the current status of trial NCT00479765?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2007-03. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00479765?
The interventions under investigation include: OncoGel (ReGel/Paclitaxel) (DRUG).
Who is sponsoring clinical trial NCT00479765?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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