Table 2.
Demographic and baseline characteristics (safety population).
| Characteristic | N = 27 |
|---|---|
| Median age (range), years | 61 (43–71) |
| Male sex, n (%) | 25 (93) |
| Caucasian,a n (%) | 24 (89) |
| Median time since diagnosis (range), mo | 24 (0–146) |
| Karnofsky performance status,b n (%) | |
| 100% | 18 (67) |
| 90% | 5 (19) |
| 80% | 4 (15) |
| ECOG Performance Status, n (%) | |
| 0 | 23 (85) |
| 1 | 4 (15) |
| No. of organs involved,c n (%) | |
| 1 | 4 (15) |
| 2 | 11 (41) |
| 3 | 6 (22) |
| 4 | 3 (11) |
| ≥5 | 3 (11) |
| No. of prior VEGF treatments, n (%) | |
| 0 | 7 (26) |
| 1 | 19 (70) |
| 2 | 1 (4) |
| Prior VEGF treatments, n (%) | |
| Bevacizumab | 3 (11) |
| Sorafenib | 10 (37) |
| Sunitinib | 8 (30) |
| Prior cytokine therapy,d n (%) | 7 (26) |
| Prior surgery, n (%) | 26 (96) |
| Prior radiotherapy, n (%) | 4 (15) |
ECOG, Eastern Cooperative Oncology Group; VEGF, vascular endothelial growth factor.
a
Includes patients self-reported as Caucasian.
b
Percentages may not add to 100% due to rounding.
c
The most common sites for metastases were lung (n = 21 [78%]), lymph nodes (n = 17 [63%]) and liver (n = 9 [33%]).
d
Two patients in cohort 1 (n = 1 each in adjuvant and metastatic settings), two patients in cohort 2 (both in metastatic setting) and three patients in the R2PD cohort (all in metastatic setting) had received prior cytokine therapy.