Table 2. Dose escalation and dose-limiting toxicities (first cycle of therapy).
| Saracatinib dose, mg | Saracatinib with C+P q3w ( N =24) | Saracatinib with C q3w ( N =21) | Saracatinib with P q3w ( N =27) | Saracatinib with P q1w ( N =24) |
|---|---|---|---|---|
| 125 | 5/7 | 6/7 | 3/3 | 3/3 |
| 175 | 6/11 | 8/14 • Grade 3 fatigue • Grade 3 colitis ulcerativea | 6/6 • Grade 5 neutropenic sepsis | 10/13 |
| 225 | 5/6 • Grade 3 hyponatraemia | — | 4/7 | 6/8 • Grade 3 neutropenia • Grade 4 febrile neutropenia |
| 250 | — | — | 6/8 • Grade 3 febrile neutropenia | — |
| 300 | — | — | 0/3 | — |
Abbreviations: C=carboplatin; P=paclitaxel. Number of evaluable patients/total patients per cohort; bullet points indicate dose-limiting toxicities. aExacerbation of pre-existing condition.