Table 2:

Treatment Summary

Nab-paclitaxel (mg/m2)	Patients treated	Patients excluded from course one tox. eval.	Patients excluded from response evaluation	Completed cycles median (range) (excluding ineligible patients for response)	Patients with DLTs	DLT description	Best responses during therapy (all eligible patients for response)
Cohort 1 – 35	4	1*	1*	2 (2–2)	0	-	PD – 3 NA – 1
Cohort 2 – 70	4	1**	0	15 (6–18)	0	-	CR - 1 SD – 3
Cohort 3 – 90	3	0	0	2 (2–10)	0	-	SD – 1 PD – 2
Cohort 4 – 112.5	6	0	2***	2 (1–3)	1	Gr3 Leukocyte Cnt Decr and Gr3 Neutrophil Cnt Decr	SD – 2 PD – 2 NA – 2
Cohort 5 – 140	7	0	0	2 (2–12)	0	-	PR – 1 SD – 3 PD – 3
Cohort 6 – 175	3	0	1#	2 (1–4)	1##	Gr4 Neutrophil Cnt Decr and Gr3 Abdominal Pain	SD – 1 PD – 1 NA – 1

^*Second patient did not receive full course of course 1 treatment due to port complications; terminated treatment prior to completion of course 2.

^**Second patient held treatment on day 8 of course 1 due to low wbc (not a DLT).

^***Second patient terminated treatment due to toxicity and the third patient died (sepsis) prior to the first disease evaluation.

^#:Third patient off treatment for toxicity prior to first disease evaluation.

^##:Second patient on arm 6 had grade 4 ANC, and decr ejection fraction cycle 4.