A Phase I Trial of BAY 43-9006 for Patients With Recurrent or Progressive Malignant Glioma
I. To determine the maximum tolerated dose (MTD) of BAY 43-9006 when administered to adults
with recurrent malignant glioma, receiving (Group A) or not receiving (Group B)
anticonvulsants known to be metabolized by the P450 hepatic enzyme complex.
II. To assess and estimate the dose-related toxicities. III. To describe the
pharmacokinetics of this route of administration, measuring BAY 43-9006, and to assess the
pharmacokinetic difference between patients taking enzyme-inducing agents and those who are
IV. To estimate overall survival.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
the concurrent use of cytochrome P450-inducing anticonvulsants (yes vs no).
Patients receive oral sorafenib twice daily on days 1-28 (once daily on day 1 of course 1
only). Courses repeat every 28 days in the absence of disease progression or unacceptable
Cohorts of 3-6 patients per stratum receive escalating doses of sorafenib until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 3 of 6 patients experience dose-limiting toxicity.
Patients are followed every 2 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of sorafenib tosylate in patients with recurrent or progressive malignant glioma, receiving (group A) or not receiving (group B) anticonvulsants known to be metabolized by the P450 hepatic enzyme complex
National Cancer Institute (NCI)
United States: Food and Drug Administration
|Adult Brain Tumor Consortium||Baltimore, Maryland 21231-1000|