Table 1.
Dose, mg/kg | n | Reason for withdrawal | |
---|---|---|---|
Dose escalation (n = 26) | Not dosed | 1 | Other (patient enrolled but not included in the safety population) |
3.2 | 6 | PD (n = 2), AE (n = 2), symptomatic deterioration (n = 2) | |
6 | 3 | PD (n = 2), death (n = 1) | |
10 | 4 | PD (n = 3), symptomatic deterioration (n = 1) | |
15 | 3 | PD (n = 2), withdrew consent (n = 1) | |
20 | 5 | PD (n = 2), withdrew consent (n = 1), symptomatic deterioration (n = 2) | |
40/20 | 4 | PD (n = 3), symptomatic deterioration (n = 1) | |
Dose expansion (n = 18) | 40/20 | 18 | PD (n = 14), investigator decision (n = 1), symptomatic deterioration (n = 3) |
40/20 40 mg/kg loading dose followed by 20 mg/kg maintenance dose, AE adverse event, PD progressive disease