Table 5.
Treatment exposure and clinical activity.
| Patient no | No. of started cycles | Duration of treatment (months) | PFS (months) | Best overall response (Best OR) | Evaluation of the best OR by | End of treatment (EOT) reason | |
|---|---|---|---|---|---|---|---|
| 100 mg/m2 | 1 | 2 | 1.4 | 1.6 | Progressive disease | RECIST | Progression of disease |
| 2 | 2 | 1.6 | 1.8 | Progressive disease | RECIST | Progression of disease | |
| 3 | 1 | one dose only | 0.5 | Progressive disease | immediate clinical progression | Progression of disease | |
| 4 | 2 | 1.6 | 1.7 | Progressive disease | RECIST | Progression of disease | |
| 150 mg/m2 | 5 | 3 | 2.3 | 2.8 | Stable disease | GCIC CA125 | SAE (SUSAR) |
| 6 | 10 | 9.2 | 9.3 | Stable disease | RECIST | Progression of disease | |
| 7 | 6 | 5.3 | 7.9 | Partial response* | RECIST | Investigator and patient decision | |
| 8 | 2 | 1.6 | 5.0 | Stable disease | RECIST | SAE | |
| 9 | 3 | 1.8 | 4.4 | Stable disease | RECIST | SAE (SUSAR) | |
| 10 | 11 | 10.1 | 10.3 | Partial response | GCIC CA125 | Progression of disease |
*
Confirmed response.