Phase I Trial of E7389 (Halichondrin B Analog) (NSC# 707389) in Patients With Advanced Solid Tumors
I. To determine the maximum tolerated dose (MTD) of E7389 administered as an IV bolus over
1-2 minutes weekly for 3 weeks.
II. To describe the toxicities of E7389. III. To evaluate the pharmacokinetics of E7389. IV.
To determine the in vivo anti-mitotic activity of E7389 by cell cycle analysis and
immunohistochemistry in pre- and post-treatment tumor biopsies.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4
weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of E7389 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients
experiences dose-limiting toxicity.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of eribulin mesylate defined as the highest dose tested in which no more than 1 of first 6 patients evaluated for toxicity experience dose-limiting toxicity (DLT) as assessed by NCI CTC version 2.0
Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, time of onset (i.e., course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by cycle.
Beckman Research Institute
United States: Food and Drug Administration
|City of Hope||Duarte, California 91010|