drugset / Trial / NCT00864175

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

NCT00864175

Phase 1/2 Terminated 68 enrolled Incyte Corporation
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2007-07
Primary completion
2011-06
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject ADERBASIB Small molecule 100 mg
Subject ADERBASIB Small molecule 200 mg
Subject ADERBASIB Small molecule 300 mg
Background Docetaxel Small molecule
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications