Table 1.

ALN-VSP phase I trial: demographics and dosing

Total study population, N41
 Dose escalation (0.1–1.5 mg/kg)30
 Expansion phase at 1.0 and 1.25 mg/kg11 (6 at 1.0 mg/kg, 5 at 1.25 mg/kg)
Median age57 (range, 34–78)
Male:female17:24
ECOG performance status 0/1, %44/56
Average number of prior regimens for metastatic disease4.3 (range, 0–15)
Prior chemotherapy/anti-VEGF therapy, %88/61
Liver/extrahepatic metastases, %98/88
Tumor types, N
 Gastrointestinal24
 Gynecological9
 Genitourinary3
 Sarcoma2
 Other3
Doses administered277
Average number of doses/patient6.8 (range, 1–50)

Abbreviation: ECOG, Eastern Cooperative Oncology Group.