A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors
I. To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced
II. To determine the safety and toxicity of this regimen in these patients. III. To
determine the pharmacokinetics of this regimen in these patients.
Outline: This is a multicenter, dose-escalation study. Patients receive eribulin mesylate IV
over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 8 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
City of Hope Medical Center
United States: Food and Drug Administration
|City of Hope Medical Center||Duarte, California 91010|
|City of Hope||Duarte, California 91010|
|UC Davis Comprehensive Cancer Center||Sacramento, California 95817|
|University of Southern California||Los Angeles, California 90033|