. Author manuscript; available in PMC: 2018 Feb 12.

Published in final edited form as: Invest New Drugs. 2016 Dec 21;35(3):290–297. doi: 10.1007/s10637-016-0418-8

Table 3.

Dose levels and DLTs

Dose Level	Enrolled	Unevaluable	DLT
1	8	2	None
2	8	2	1^*
3	5	1	2^**
Expansion	8	2	1^***

Grade 4 neutropenia and grade 3 mucositis,

^**

One patient with grade 3 abdominal pain, one patient with grade 4 neutropenia/grade 3 febrile neutropenia,

^***

Grade 2 mucositis that resulted to inability to deliver > 75% of the protocol specified cycle 1 treatment