Dose Level | Ridaforolimus mg (days of cycle) | Carboplatin (AUC) | No. of Patients Enrolled | No of Patients evaluable for DLTa | Dose-Limiting Toxicity |
---|---|---|---|---|---|
1 | 10 (days 1–5, 8–12, 15–19) | 5 | 4 | 4 | Two grade 4 neutropenia |
1A | 10 (days 1–5, 8–12) | 5 | 6 | 6 | Death from sepsis |
2A | 20 (days 1–5, 8–12) | 5 | 4a | 3 | None |
3A | 30 (days 1–5, 8–12) | 5 | 3 | 3 | None |
4A | 30 (days 1–5, 8–12) | 6 | 7b | 6 | Grade 3 mucositis; grade 4 thrombocytopenia requiring transfusion |