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NCT00979173 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics (PK) Study of AC480 for Recurrent Glioma
A Phase 1 study of Glioma, sponsored by Annick Desjardins.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00979173 is a Phase 1 study of Glioma that has completed, run by Annick Desjardins. The registered enrollment target is 5 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00979173, a Phase 1 study of Glioma, has completed, sponsored by Annick Desjardins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective is to evaluate the intratumoral and plasma pharmacokinetics of AC480 among patients who are candidates for a resection with a recurrent malignant glioma who are not on CYP-3A enzyme inducing anti-epileptic drugs (EIAEDS). Secondary objectives include the following: to evaluate the antiproliferative effect of AC480 by FDG-PET Scan; to evaluate the safety and tolerability of AC480; and, to describe 6-month progression-free survival (PFS) and radiographic response. This is a single institution, open label, pharmacokinetic study of AC480 in patients with recurrent malignant glioma. The study will enroll 5 patients who are not on enzyme inducing anti-epileptic drugs (EIAEDs) and are scheduled to undergo salvage surgical resection for preoperative treatment with AC480 at 300 mg orally twice daily (BID) for 14 (plus or minus 2) days before surgery (Part I- Induction Therapy). After surgery (Part II- Maintenance Therapy), patients will continue to be dosed with AC480 until disease progression or intolerance, and will be evaluated after every other cycle (1 cycle is 28 days).
Conditions Studied
Interventions
- DRUG AC480
Study Locations (1)
North Carolina
- The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00979173
The ClinicalTrials.gov registry entry for NCT00979173 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (98% lower). The listed sponsor is Annick Desjardins, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which AC480 is the first listed.
NCT00979173 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00979173 about?
NCT00979173 is a clinical study titled "Pharmacokinetics (PK) Study of AC480 for Recurrent Glioma". The primary objective is to evaluate the intratumoral and plasma pharmacokinetics of AC480 among patients who are candidates for a resection with a recurrent malignant glioma who are not on CYP-3A enzyme inducing anti-epileptic drugs (EIAEDS). Secondary objectives include the following: to evaluate ...
What is the current status of trial NCT00979173?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2009-11. Estimated completion is 2012-06.
What conditions does trial NCT00979173 study?
This clinical trial studies the following conditions: Glioma.
What interventions are being tested in trial NCT00979173?
The interventions under investigation include: AC480 (DRUG).
Who is sponsoring clinical trial NCT00979173?
This trial is sponsored by Annick Desjardins, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00979173 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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