Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

June 30, 2011

Study Completion Date

October 31, 2011

Conditions
Breast Cancer
Interventions
DRUG

INCB007839

100 mg BID

DRUG

INCB007839

200 mg BID

DRUG

INCB007839

300 mg BID

DRUG

INCB007839

300 mg BID

DRUG

trastuzumab

trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.

DRUG

Docetaxel

Trial Locations (12)

Unknown

Visakhapatnam

New Delhi

Mangalore

Bangalore

Hyderabaad

Bangalore

Delhi

Delhi

Bhopal

Kolkata

Nashik

Pune

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY