No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study Current or planned use of other investigational agents, or concurrent biological chemotherapy, or radiation therapy during the study treatment period Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period Current use (or planned use during the treatment period) of other investigational agents, or biological, chemotherapy, radiation or other anti-tumor therapy Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period Current use (or planned use during the treatment period) of other investigational agents, or biological, chemotherapy, radiation or other anti-tumor therapy Current active treatment with chemotherapy, radiation or surgery in the past months or planned treatment during this study protocol period; hormonal therapy is allowed Current active treatment with chemotherapy, radiation or surgery in the past months or planned treatment during this study protocol period; hormonal therapy is allowed