Status:
TERMINATED
Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer
Lead Sponsor:
Incyte Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01254136
Start Date
October 1 2010
End Date
October 1 2011
Last Update
January 25 2012
Active Locations (14)
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1
Fayetteville, Arkansas, United States
2
Duarte, California, United States
3
Denver, Colorado, United States
4
Davie, Florida, United States