Table 1.
Dose Level | Erlotinib (oral, daily) | Temsirolimus (IV, weekly) | Number of patients treated | Number of patients eligible for DLT evaluation | Number of patients experiencing DLT |
---|---|---|---|---|---|
1A | 100 mg | 10 mg | 1 | 1 | 0 |
1 | 100 mg | 15 mg | 15 | 9 | 2 (G3 dehydration, n=1; G3 acute renal failure, n=1) |
2 | 100 mg | 20 mg | 5 | 3 | 0 |
3 | 100 mg | 25 mg | 4 | 3 | 0 |
Dose Expansion Phase | 100 mg | 25 mg | 16 | 16 | 0 |
DLT, dose limiting toxicity; G, grade