Status:
TERMINATED
Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer
Lead Sponsor:
Incyte Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive
- Measurable disease as defined by the RECIST criteria
- Life expectancy greater than or equal to 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion
- Received any anticancer medications in the 28 days prior to enrollment into this study
- Received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
- History of deep venous thrombosis within the last year
- Contraindication to low dose warfarin therapy
- Clinically significant cardiomyopathy
- Prior treatment with INCB007839 or trastuzumab or lapatinib
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00864175
Start Date
July 1 2007
End Date
October 1 2011
Last Update
January 18 2018
Active Locations (12)
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1
Visakhapatnam, Andhra Pradesh, India
2
New Delhi, Ansari Nagar, India
3
Mangalore, Attavar, India
4
Bangalore, Karnataka, India