Concurrent therapy with approved or investigational anticancer therapeutics. No concurrent therapy with approved or investigational anticancer therapeutics Concurrent use of other anticancer approved or investigational agents is not allowed. Concurrent therapy with approved or investigational anticancer therapy Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within weeks of first dose Concurrent therapy with approved or investigational anticancer therapeutic other than steroids Concurrent use of other anticancer approved or investigational agents is not allowed. SUB-PROTOCOL AIM A: Concurrent use of any other approved or investigational anticancer agents which would be considered as a treatment for the primary neoplasm Concurrent use of any other approved or investigational anticancer agents, including hormonal agents Concurrent therapy with approved or investigational anticancer therapeutic Concurrent therapy with approved or investigational anticancer therapeutic Concurrent therapy with approved or investigational anticancer therapeutic other than steroids Concurrent therapy with approved or investigational anticancer therapeutic other than steroids Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within days of first dose Chemotherapy with approved or investigational anticancer therapeutics within days prior to randomization. Concurrent therapy with approved or investigational anticancer therapeutic other than steroids Concurrent therapy with approved or investigational anticancer therapeutics