Part 1 Cohorts | ||||||||||
125 mg/m2 (n = 3) | 250 mg/m2 (n = 6) | 500 mg/m2 (n = 8) | 750 mg/m2 (n = 4) | 1125 mg/m2 (n = 3) | 1500 mg/m2 (n = 3) | 1875 mg/m2 (n = 6) | 2500 mg/m2 (n = 6) | 3250 mg/m2 (n = 4) | Total (n = 43) | |
Best overall response, n (%) | ||||||||||
Complete response | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Partial response | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Stable disease | 0 | 0 | 3 | 1 | 3 | 2 | 2 | 2 | 3 | 16 (37.2) |
Progressive disease | 3 | 3 | 2 | 2 | 0 | 1 | 4 | 3 | 0 | 18 (41.9) |
Response ratea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Disease control rateb | 0 | 0 | 3 | 1 | 3 | 2 | 2 | 2 | 3 | 16 (37.2) |
Part 2 Cohorts | ||||||||||
1500 mg/m2 (n = 4) | 1875 mg/m2 (n = 6) | 2500 mg/m2 (n = 6) | Total (n = 16) | |||||||
Best response, n (%) | ||||||||||
Complete response | 0 | 0 | 0 | 0 | ||||||
Partial response | 0 | 0 | 0 | 0 | ||||||
Stable disease | 3 | 1 | 0 | 4 (25) | ||||||
Progressive disease | 1 | 5 | 4 | 10 (62.5) | ||||||
Response ratea | 0 | 0 | 0 | 0 | ||||||
Disease control rateb | 3 | 1 | 0 | 4 (25) |