ARRY-380 + Trastuzuamab for Breast w/ Brain Mets

PHASE1CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

March 31, 2018

Study Completion Date

December 31, 2023

Conditions
Brain Metastases From HER2 and Breast CancerAdvanced HER2-positive Breast Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

Trastuzumab

6 mg/kg IV every 3 weeks

Trial Locations (2)

02114

Massachusetts General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

Array BioPharma

INDUSTRY

collaborator

Breast Cancer Research Foundation

OTHER

lead

Dana-Farber Cancer Institute

OTHER