Trial Information
A Phase 1/2, Modified Dose Escalation, Open Label Trial to Determine the Therapeutic Effect and Safety of INCB007839 Combined With Trastuzumab in Patients With Previously Untreated HER2 Positive Metastatic Breast Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
Outcome Time Frame:
Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.
Safety Issue:
No
Principal Investigator
Bijyoyesh Mookerjee, MD
Investigator Role:
Study Director
Investigator Affiliation:
Incyte Corporation
Authority:
United States: Food and Drug Administration
Study ID:
INCB 7839-202
NCT ID:
NCT00864175
Start Date:
July 2007
Completion Date:
October 2011
Related Keywords:
- Metastatic Breast Cancer
- Breast Neoplasms