Pharmacokinetics (PK) Study of AC480 for Recurrent Glioma
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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).