Table 4.
Response Based on Investigator Assessment
Objective Response/Response Duration | n (%) |
||
---|---|---|---|
Dose Level 1 (n = 7) | Dose Level −1 (n = 18) | All Patients (N = 25) | |
Partial response | 1 (14) | 1 (6) | 2(8) |
Stable disease | 2 (29) | 6 (33) | 8(32) |
Objective progression | 4(57) | 6 (33) | 10 (40) |
Early death | 0 | 2(11) | 2(8) |
Indeterminatea | 0 | 3 (17) | 3 (12) |
Objective response rate, % (95% exact CI) | 14 (<1–58) | 6 (<1 −27) | 8 (1–26) |
Duration of stable diseaseb | |||
0 to <3 months | 1 (50) | 0 | 1 (13) |
3 to <6 months | 0 | 6 (100) | 6(75) |
6 to <9 months | 0 | 0 | 0 |
9 to <12 months | 0 | 0 | 0 |
>12 months | 1 (50) | 0 | 1 (13) |
Note: Dose level of 1: crizotinib, 150 mg twice daily, plus erlotinib, 100 mg daily. Dose level of 1: crizotinib, 200 mg twice daily, plus erlotinib, 100 mg daily.
Withdrawn from study before first scan during treatment.
In patients with stable disease.
CI, confidence interval.