11. *Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (see protocol attachment 2) 12. *Patient must have a life expectancy ≥ 16 weeks 13. *Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.