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 |
Cohort 1 received 40 mg/m2 over a 4.5-hour period, based on PK modeling of preclinical data determining the BED
Cohort 2 received 40 mg/m2 over a 1-hour period, a duration selected based on PK exposure data for Cohort 1
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
Later determined to be unrelated to LY2603618
Platelet count <25,000 cells/m2