Table 2.
Patient disposition
| Phase 1 |
Phase 2A | MTDa | Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Weekly |
Bi-weekly |
|||||||||
| Statistic | 6 mg/m2 (n=6) |
12 mg/m2 (n=3) |
18 mg/m2 (n=3) |
12 mg/m2 (n=3) |
15 mg/m2 (n=6) |
18 mg/m2 (n=3) |
15 mg/m2 (n=38) |
15 mg/m2 (n=44) |
(n=62) | |
| Safety Population | n | 6 | 3 | 3 | 3 | 6 | 3 | 38 | 44 | 62 |
| MTD Population | n (%) | 0 | 0 | 0 | 0 | 6 (100.0) | 0 | 38 (100.0) | 44 (100.0) | 44 (71.0) |
| NSCLC Population | n (%) | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 21 (55.3) | 22 (50.0) | 22 (35.5) |
| Primary Reason for Discontinuation | ||||||||||
| Progressive Disease | n (%) | 5 (83.3) | 1 (33.3) | 1 (33.3) | 2 (66.7) | 5 (83.3) | 1 (33.3) | 21 (55.3) | 26 (59.1) | 36 (58.1) |
| Adverse Event | n (%) | 1 (16.7) | 2 (66.7) | 1 (33.3) | 1 (33.3) | 1 (16.7) | 0 | 8 (21.1) | 9 (20.5) | 14 (22.6) |
| Withdrew Consent | n (%) | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (2.6) | 1 (2.3) | 2 (3.2) |
| Investigator Discretion | n (%) | 0 | 0 | 0 | 0 | 0 | 1 (33.3) | 3 (7.9) | 3 (6.8) | 4 (6.5) |
| Symptomatic Deterioration | n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 3 (7.9) | 3 (6.8) | 3 (4.8) |
| Increase Tumor Marker (CA19-9) | n (%) | 0 | 0 | 0 | 0 | 0 | 1 (33.3) | 2 (5.3) | 2 (4.5) | 3 (4.8) |
| Duration of Treatment | ||||||||||
| Days | Mean | 132.8 | 94.0 | 115.3 | 76.3 | 130.0 | 78.3 | 107.4 | 110.5 | 108.9 |
| SD | 254.7 | 107.4 | 139.0 | 45.4 | 132.0 | 92.1 | 100.7 | 104.0 | 120.3 | |
| Median | 36.0 | 35 | 57.0 | 58.0 | 97.5 | 36.0 | 98.5 | 98.5 | 62.0 | |
| Range | 15-652 | 29-218 | 15-274 | 43-128 | 43-393 | 15-184 | 1^122 | 1-422 | 1-652 | |
| Cycles | Mean | 4.5 | 4.0 | 4.3 | 3.0 | 4.5 | 2.3 | 4.1 | 4.2 | 4.1 |
| SD | 7.1 | 3.5 | 4.9 | 1.0 | 3.8 | 2.3 | 3.3 | 3.3 | 3.7 | |
| Median | 2.0 | 2.0 | 2.0 | 3.0 | 3.5 | 1.0 | 4.0 | 4.0 | 3.0 | |
| Range | 1-19 | 2-8 | 1-10 | 2-4 | 2-12 | 1-5 | 1-14 | 1-14 | 1-19 | |
MTD maximum tolerated dose; SD standard deviation
a
Includes all patients from Phase 1 to 2a treated at the MTD dos(