Table 2.
Level | Paclitaxel (mg/m2) D1, 8, 15 Q 4 weeks |
AZD8186 (total mg/day) 5 days on/2 days off |
---|---|---|
1 | 80 | 120 (60 mg BID) |
2 | 80 | 240 (120 mg BID) |
−1 | 70 | 240 (120 mg BID) |
−2 | 70 | 120 (60 mg BID) |
On the phase Ib stage, 4 dose levels were planned. The traditional 3+3 design was applied to these 4 dose levels. The level −1 was planned to be tested if the dose level 2 was deemed to be intolerable (dose-limiting toxicity [DLT] occurs in ≥2 out of 6 people). The level −2 was planned to be tested if the dose level 1 was deemed to be intolerable (DLT occurs in ≥2 out of 6 people).