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

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

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 clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Docetaxel; Trastuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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