Table 1 Baseline patient demographic, characteristics and treatment allocation.
Characteristics | Dose escalation cohort | ||||
|---|---|---|---|---|---|
Cohort | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
PD-0325901 | 2 mg B.D | 2 mg B.D | 4 mg B.D | 8 mg B.D | (n = 25) |
crizotinib | 250 mg O.D (n = 6) | 200 mg B.D (n = 5) | 200 mg B.D (n = 6) | 200 mg B.D (n = 8) | |
Demographics | |||||
Age (years) median (range) | 65.8 (36–78) | 64.8 (48–69) | 58.4 (52–71) | 61.2 (36–73) | 63.4 (36–78) |
Gender | |||||
Male, n (%) | 2 (33.3) | 2 (40) | 3 (50) | 6 (75) | 13 (52) |
Female, n (%) | 4 (66.7) | 3 (60) | 3 (50) | 2 (25) | 12 (48) |
ECOG PS | |||||
0, n (%) | 1 (16.7) | 2 (40) | 1 (16.7) | 4 (50) | 8 (32) |
1, n (%) | 5 (83.3) | 3 (60) | 5 (83.3) | 4 (50) | 17 (68) |
Tumour origin | |||||
Hepatobiliary – pancreatic Cancer, n (%) | 1 (16.7) | 1 (20) | 0 (0) | 0 (0) | 2 (8) |
Colorectal Cancer (incl. Appendiceal), n (%) | 2 (33.3) | 2 (40) | 4 (66.6) | 5 (62.5) | 13 (52) |
Gastric Cancer, n (%) | 0 (0) | 0 (0) | 0 (0) | 2 (25) | 2 (8) |
Small Bowel Cancer, n (%) | 1 (16.7) | 0 (0) | 0 (0) | 0 (0) | 1 (4) |
CUP (cancer of unknown primary), n (%) | 1 (16.7) | 0 (0) | 1 (16.7) | 0 (0) | 2 (8) |
Renal, n (%) | 1 (16.7) | 0 (0) | 0 (0) | 0 (0) | 1 (4) |
Ovarian, n (%) | 0 (0) | 1 (20) | 1 (16.7) | 0 (0) | 2 (8) |
Cervix, n (%) | 0 (0) | 1 (20) | 0 (0) | 0 (0) | 1 (4) |
Lung, n (%) | 0 (0) | 0 (0) | 0 (0) | 1 (12.5) | 1 (4) |
Median range of prior systemic therapies | |||||
1–2, n (%) | 3 (50) | 2 (40) | 0 (0) | 5 (62.5) | 10 (40) |
3–4, n (%) | 3 (50) | 2 (40) | 3 (50) | 2 (25) | 10 (40) |
5–6, n (%) | 0 (0) | 1 (20) | 1 (16.7) | 1 (12.5) | 3 (12) |
≥ 7, n (%) | 0 (0) | 0 (0) | 2 (33.3) | 0 (0) | 2 (8) |
