A clinical trial to study the effect and safety of INCB007839 combined with Trastuzumab in patients with previously untreated HER2 positive metastatic breast cancer.
- Registration Number
- CTRI/2009/091/000834
- Lead Sponsor
- INCYTE Corporation, USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive as defined by positive fluorescent in situ hybridization (FISH)
-Left ventricular ejection fraction (LVEF) by either MUGA scan or echocardiography that is considered to be within the normal limits as defined by the testing laboratory
-Received prior chemotherapy for metastatic breast cancer (Adjuvant or neoadjuvant chemotherapy is allowed.)(Hormonal therapy is allowed both as adjuvant therapy and as therapy for metastatic disease and stable ongoing hormonal therapy is allowed to be continued during this study.)
-History of deep venous thrombosis within the last year
-Presence of deep venous thrombosis on screening Doppler
-Contraindication to low dose warfarin therapy
-Contraindication to low dose aspirin therapy
-History of clinically significant Cardiomyopathy
-Malabsorption syndrome, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
-Prior treatment with INCB007839 or trastuzumab or lapatinib.
-Prior hypersensitivity reaction to drugs formulated with polysorbate-80.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method