4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. i) Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. ii) If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. iii) Toxicity that has not recovered to ≤ Grade 1 is allowed if it meets the inclusion requirements for laboratory parameters defined in points 8 & 9 under inclusion criteria.