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. Author manuscript; available in PMC: 2016 May 18.
Published in final edited form as: Contemp Clin Trials. 2010 Jun 2;31(5):473–482. doi: 10.1016/j.cct.2010.05.010

Table 6.

Summary of dose level and toxicity of patients in A09712.a

Dose level Treatment Toxicities

Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6
1 1.7 mg/kg/dose M–F*3w 2G2
3G1
None 1G2
2G1
1G2
4G1
2 1.7 mg/kg/dose MWF*6w 1G1 None 2G1 2G1
3 1.7 mg/kg/dose M–F*6w 3G2
5G1
1G2
1G1
1G1 None
4 1.9 mg/kg/dose M–F*6w None 1G1 1G3DLT
2G3
5G2
1G1
1G2
2G1
4G1 1G2
3G1
5 3.4 mg/kg/dose M–F*6w 1G2
1G1
2G1 2G1 None
6* 4.4 mg/kg/dose M–F*6w 1G2
1G1
2G2
1G1
2G2
2G1
1G3DLT
2G3
2G2
2G1
2G2
2G1
1G3
3G2
6G1
7 5.5 mg/kg/dose M–F*6w 1G2 1G2
1G1
2G2
2G1
1G3DLT
1G2
2G1
1G3DLT
1G3
2G2
1G1
2G2
6G1
8 7.1 mg/kg/dose M–F*6w 2G2
1G1
2G2
1G1
2G2
2G1
1G3DLT
1G3
2G2
3G1
1G3DLT
1G3
4G2
5G1
9 9.2 mg/kg/dose M–F*6w 1G3DLT
2G3
4G2
2G1
1G3DLT
1G2
1G1

nGm: n grade m non-DLT toxicities. nGmDLT: n grade m DLT toxicities.

*

Recommended maximum tolerated dose (MTD) by original Standard 3+3 design with dose de-escalation.

a

M: Monday. F: Friday. w: week. DLT: dose limiting toxicity.