Table 1.
Patient demographics and baseline characteristics
AZD4547 dose | ||||||
---|---|---|---|---|---|---|
Part A | Part B | |||||
40 mg bid | 80 mg bid | 120 mg bid | 160 mg qd | Total Part A | 80 mg bid | |
(N = 3) | (N = 6) | (N = 6) | (N = 15) | (N = 30) | (N = 4) | |
Sex, n (%) | ||||||
Female | 1 (33.3) | 4 (66.7) | 2 (66.7) | 7 (46.7) | 14 (46.7) | 1 (25.0) |
Male | 2 (66.7) | 2 (33.3) | 4 (33.3) | 8 (53.3) | 16 (53.5) | 3 (75.0) |
Median age, years | 49 | 63.5 | 61.5 | 66.0 | 63.5 | 71.5 |
(range) | (41–73) | (30–76) | (47–76) | (51–78) | (30–78) | (64–76) |
WHO performance status, n (%) | ||||||
0 | 3 (100) | 5 (83.3) | 3 (50.0) | 7 (46.7) | 18 (60.0) | 2 (50.0) |
1 | 0 (0) | 1 (16.7) | 3 (50.0) | 8 (53.3) | 12 (40.0) | 2 (50.0) |
Local/metastatic sites, n (%) | ||||||
Local only | 0 (0) | 0 (0) | 1 (16.7) | 1 (6.7) | 2 (6.7) | 0 |
Local/metastatic | 3 (100) | 6 (100) | 5 (83.3) | 14 (93.3) | 28 (93.3) | 4 (100) |
Common primary tumour types, n (%) | ||||||
Bile duct | 0 (0) | 0 (0) | 0 (0) | 1 (6.7) | 1 (3.3) | 0 (0) |
Bladder | 0 (0) | 0 (0) | 0 (0) | 1 (6.7) | 1 (3.3) | 0 (0) |
Breast | 0 (0) | 4 (66.7) | 0 (0) | 1 (6.7) | 5 (16.7) | 1 (25.0) |
Caecum | 1 (33.3) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) |
Colon | 1 (33.3) | 1 (16.7) | 0 (0) | 0 (0) | 2 (6.7) | 0 (0) |
Colorectal | 0 (0) | 0 (0) | 0 (0) | 1 (6.7) | 1 (3.3) | 0 (0) |
Lung | 0 (0) | 1 (16.7) | 3 (50.0) | 6 (40.0) | 10 (33.3) | 1 (25.0) |
Oesophagus | 0 (0) | 0 (0) | 0 (0) | 1 (6.7) | 1 (3.3) | 0 (0) |
Pancreas | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (3.3) | 0 (0) |
Rectal | 0 (0) | 0 (0) | 0 (0) | 1 (6.7) | 1 (3.3) | 0 (0) |
Stomach | 0 (0) | 0 (0) | 1 (16.7) | 3 (20.0) | 4 (13.3) | 2 (50.0) |
Thymus | 1 (33.3) | 0 (0) | 0 (0) | 0 (0) | 1 (3.3) | 0 (0) |
Urachus | 0 (0) | 0 (0) | 1 (16.7) | 0 (0) | 1 (3.3) | 0 (0) |
Prior therapy, n (%) | ||||||
Chemotherapy | 2 (66.7) | 6 (100) | 6 (100) | 15 (100) | 29 (96.7) | 4 (100) |
Other systemic anticancer therapy | 2 (66.7) | 2 (33.3) | 1 (16.7) | 6 (40.0) | 11 (36.7) | 1 (25.0) |
Radiotherapy | 3 (100) | 6 (100) | 6 (100) | 15 (100) | 30 (100) | 4 (100) |
Hormonal/immunotherapy | 0 (0) | 1 (16.7) | 0 (0) | 2 (13.3) | 3 (33.3) | 0 (0) |