Table 3 Dose escalation schemes and dose-limiting toxicities on cycle one
| Â | PR104 Dose | Patients | Dose-limiting toxicities | |
|---|---|---|---|---|
| Â | Level | mg/m2 | (n) | Â |
Group A PR104 + gemcitabine | 1 | 275 | 3 | Grade 4 thrombocytopenia (n=2) |
2 | 140 | 6 | - | |
Group B PR104 + docetaxel 60 | 1 | 400 | 3 | Grade 3 neutropenic fever (n=1) |
2 | 200 | 3 | Grade 3 neutropenic fever (n=2) | |
Group C PR104 + docetaxel 60 + GCSF | 1 | 200 | 3 | - |
2 | 400 | 3 | - | |
3 | 550 | 3 | - | |
4 | 770 | 6 | - | |
5 | 1100 | 6 | Grade 4 thrombocytopenia (=1) Grade 3 Fatigue (n=1) | |
Group D PR104 + docetaxel 75 + GCSF | 1 | 770 | 6 | - |