9. No limit to prior number of cytotoxic chemotherapies provided time since the last dose of prior therapy (in advance of Day 1 of study treatment): Cytotoxic chemotherapy ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 4 weeks for all, except minimum of 6 weeks for nitrosourea, mitomycin-C) Biologic therapy (e.g. antibodies) ≥4 weeks ≥5 X half-life of a small molecule therapeutic (e.g. tyrosine kinase inhibitor [TKI])