Table 1.
Phase I Component | ||||
Dose Level | Sorafenib (twice daily) | Bevacizumab (every 2 weeks) | ||
+2 | 400 mg BID | 5 mg/kg | ||
+1 | 400 mg BID | 2.5 mg/kg | ||
0* | 400 mg BID | 1.25 mg/kg | ||
−1 | 400 mg BID, 5 consecutive days out of each 7 days | 1.25 mg/kg | ||
(−2a) | 200 mg BID days 1–28 | 2.5 mg/kg | ||
−2 | 200 mg BID days 1–28 | 1.25 mg/kg | ||
(−3b) | 200 mg BID, days 1–5 out of each 7 days | 5 mg/kg | ||
(−3a) | 200 mg BID, days 1–5 out of each 7 days | 2.5 mg/kg | ||
−3 | 200 mg BID, days 1–5 out of each 7 days | 1.25 mg/kg | ||
Phase II Component | ||||
Agent | Dose Level | Route | Day | ReRx |
Arm A | ||||
Bevacizumab | 2.5 mg/kg | IV* | Day 1, 15(+/− 3 days) | Every 4 weeks |
Sorafenib | 200 mg BID | PO | Days 1–28 | |
Arm B | ||||
Sorafenib | 400 mg BID | PO | Days 1–28 | Every 4 weeks |
Starting dose level