Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.

Key facts

Study ID

NCT01254136

Run by

Incyte Corporation

People needed

20

Starts

2010-10-01

Expected to finish

2011-10-01

Last updated by the study team

2012-01-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
• Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
• Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
• Subject with presence of measurable disease based on RECIST 1.1
• Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer

You may not qualify if…

• Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
• Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
• Subject with current active malignancy other than breast cancer
• Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
• Subject with significant renal or hepatic dysfunction
• Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
• Subject with insufficient bone marrow function
• Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
• Subject with current active bacterial, Hepatitis B or C, and/or HIV infections

Where it is running

• Study site — Fayetteville, Arkansas, United States
• Study site — Duarte, California, United States
• Study site — Denver, Colorado, United States
• Study site — Davie, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Lake Success, New York, United States
• Study site — Huntersville, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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