Summary of ovarian cancer dosing cohorts and DLT events
| Level | Gemcitabine dose (mg/m2) | Pemetrexed dose (mg/m2) | Patients (n) | DLT event detail |
|---|---|---|---|---|
| 1 | 1,500 | 300 | 4* | No DLT-evaluable patients experienced DLT |
| 2 | 1,500 | 400 | 3 | No DLT-evaluable patients experienced DLT |
| 3 | 1,500 | 500 | 6 | 1 of 6 DLT-evaluable patients experienced DLT |
| Grade 3 thrombocytopenia, failure to recover ≤1 wk | ||||
| 4 | 1,500 | 600 | 9 | 2 of 9 DLT-evaluable patients experienced DLT |
| 2 patients with febrile neutropenia | ||||
| 5 | 1,500 | 700 | 2 | 2 of 2 DLT-evaluable patients experienced DLT |
| Febrile neutropenia | ||||
| Grade 3 rash |
↵* One patient was removed from the dose level 1 cohort for probable disease progression and a fourth patient was added to meet protocol requirements for DLT assessment.