Table 2 Dose-limiting toxicities in dose-escalation cohorts
Cohort | Entinostat dose every other week (mg) | Lapatinib once daily (mg) | Trastuzumab every 3 weeks (mg/kg) | Patients, n | Patients with DLT, n | DLT(s) | |
|---|---|---|---|---|---|---|---|
Dose level | 1 | 5 | 1250 | NA | 3 | 0 | |
2 | 8 | 1250 | NA | 3 | 0 | ||
3 | 10 | 1250 | NA | 3 | 0 | ||
4 | 12 | 1250 | NA | 3 | 0 | * | |
5 | 15 | 1250 | NA | 2 | 0 | ||
6 | 12 | 1000 | 8->6 | 6 | 1 | Hypokalaemia | |
7 | 15 | 1000 | 8->6 | 5 | 2 | Thrombocytopenia, diarrhoea | |
Expansion | 6 | 12 | 1000 | 8->6 | 10 | 1 | Diarrhoea |
