ALN-VSP phase I trial: demographics and dosing
Total study population, N | 41 |
Dose escalation (0.1–1.5 mg/kg) | 30 |
Expansion phase at 1.0 and 1.25 mg/kg | 11 (6 at 1.0 mg/kg, 5 at 1.25 mg/kg) |
Median age | 57 (range, 34–78) |
Male:female | 17:24 |
ECOG performance status 0/1, % | 44/56 |
Average number of prior regimens for metastatic disease | 4.3 (range, 0–15) |
Prior chemotherapy/anti-VEGF therapy, % | 88/61 |
Liver/extrahepatic metastases, % | 98/88 |
Tumor types, N | |
Gastrointestinal | 24 |
Gynecological | 9 |
Genitourinary | 3 |
Sarcoma | 2 |
Other | 3 |
Doses administered | 277 |
Average number of doses/patient | 6.8 (range, 1–50) |
Abbreviation: ECOG, Eastern Cooperative Oncology Group.