41
Participants
Start Date
August 31, 2013
Primary Completion Date
March 31, 2018
Study Completion Date
December 31, 2023
ARRY-380 Twice Daily Dosage
ARRY-380 will be administered daily (either twice-daily along with concurrent administration of trastuzumab on Day 1. PK sampling of ARRY-380 is planned on Day 15. Blood samples will be collected at pre-dosing, 2 hours (± 1 hour), and 6 hours (± 2 hours). The same time points will be collected for BID and QD schedules. On the PK collection day participants should fast one hour before and one hour after taking ARRY-380.
ARRY-380 Once Daily
ARRY-380 will be administered daily once-daily) along with concurrent administration of trastuzumab on Day 1. PK sampling of ARRY-380 is planned on Day 15. Blood samples will be collected at pre-dosing, 2 hours (± 1 hour), and 6 hours (± 2 hours). The same time points will be collected for BID and QD schedules. On the PK collection day participants should fast one hour before and one hour after taking ARRY-380.
Trastuzumab
6 mg/kg IV every 3 weeks
Massachusetts General Hospital, Boston
Dana-Farber Cancer Institute, Boston
Collaborators (2)
Array BioPharma
INDUSTRY
Breast Cancer Research Foundation
OTHER
Dana-Farber Cancer Institute
OTHER