12
Participants
Start Date
August 31, 2011
Primary Completion Date
June 30, 2014
Study Completion Date
September 30, 2014
eribulin
During Phase I, the eribulin dose will be assigned upon study enrollment. The maximum tolerated dose (MTD) determined in Phase I will be the dose used for Phase II. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on Days 1 and 8 of each cycle.
carboplatin
Carboplatin area under the curve (AUC) 6 will be administered IV over 15 to 30 minutes on Day 1 of each cycle.
trastuzumab
Trastuzumab will be administered as an IV infusion on Day 1 of each cycle. A loading dose of 8 mg/kg of trastuzumab will be administered over 90 minutes on Cycle 1 Day 1. Then, a maintenance dose of 6 mg/kg of trastuzumab will be administered over 30 to 90 minutes on Day 1 of Cycles 2 - 6.
Northwest Georgia Oncology Centers, Marietta
Northeast Georgia Cancer Care, Athens
Holy Cross Hospital, Fort Lauderdale
The West Clinic, Memphis
Lead Sponsor
Eisai Inc.
INDUSTRY
Vector Oncology
OTHER