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. Author manuscript; available in PMC: 2013 Jul 18.
Published in final edited form as: Invest New Drugs. 2012 Apr 11;31(1):136–144. doi: 10.1007/s10637-012-9815-9

Table 2. DLTs and MTD.

Cohort N LY2603618 dose (mg/m2) DLTs (n)
1 3 40a 0
2 3 40b 0
3 3 70 0
4 13c 105 G3 diarrhea (1)
5 6 150 G4 allergic reaction/hypersensitivity (1)
6 3 195 G3 lower GI hemorrhage (1)d;
G3 fatigue (1);
G4 thrombocytopenia (2)e
a

Cohort 1 received 40 mg/m2 over a 4.5-hour period, based on PK modeling of preclinical data determining the BED

b

Cohort 2 received 40 mg/m2 over a 1-hour period, a duration selected based on PK exposure data for Cohort 1

c

Study was amended to expand patient accrual to the 105 mg/m2 dose to evaluate the PK parameters and to provide guidance on the determination of a biological dose relative to the MTD

d

Later determined to be unrelated to LY2603618

e

Platelet count <25,000 cells/m2