Patient demographics and baseline disease characteristics
| Phase IA (n=116) | Phase IB (n=335) | Overall (n=451) | |
| Age (median years)* | 60.5 (19.0 to 80.0) | 61.0 (18.0 to 81.0) | 61.0 (18.0 to 81.0) |
| Sex | |||
| Male | 55 (47.4) | 191 (57.0) | 246 (54.5) |
| Female | 61 (52.6) | 144 (43.0) | 205 (45.5) |
| Race | |||
| Asian | 10 (8.6) | 120 (35.8) | 130 (28.8) |
| African-American | 0 (0.0) | 5 (1.5) | 5 (1.1) |
| Caucasian | 101 (87.1) | 189 (56.4) | 290 (64.3) |
| Other | 5 (4.3) | 18 (5.4) | 26 (5.7) |
| ECOG performance status | |||
| 0 | 56 (48.3) | 113 (33.7) | 169 (37.5) |
| 1 | 60 (51.7) | 222 (66.3) | 282 (62.5) |
| Number of prior systemic drug therapy† | |||
| 0‡ | 18 (16.4) | 50 (15.6) | 68 (15.8) |
| 1 | 33 (30.0) | 119 (37.2) | 152 (35.3) |
| 2 | 22 (20.0) | 77 (24.1) | 99 (23.0) |
| ≥3 | 37 (33.6) | 74 (23.1) | 111 (25.8) |
| Prior radiotherapy | 63 (54.3) | 178 (53.1) | 241 (53.4) |
| Prior anticancer surgery | 100 (86.2) | 223 (66.6) | 323 (71.6) |
Data presented as n (%), except where noted.
*Data presented as median (range).
†Only therapy used for metastatic, locally advanced or palliative is counted as a line of systemic therapy. The ‘n’ is number of patients with any line of prior systemic therapies.
‡Patients may have received adjuvant and/or neoadjuvant therapies.
ECOG, Eastern Cooperative Oncology Group.