Table 1.
Baseline patient characteristics (N = 56)
| Baseline variable | Summary |
|---|---|
| Gender, n (%) | |
| Male | 36 (64%) |
| Female | 20 (36%) |
| Age, years | |
| Median (min, max) | 52 (21, 80) |
| Mean ± SD | 54.2 ± 14.7 |
| ECOG PS, n (%) | |
| 0 | 23 (41%) |
| 1 | 28 (50%) |
| 2 | 5 (9%) |
| Extent of surgery, n (%) | |
| Total resection | 18 (32%) |
| Subtotal resection | 25 (45%) |
| Biopsy only | 13 (23%) |
| Baseline steroid, n (%) | |
| Yes | 46 (82%) |
| No | 10 (18%) |
| Baseline EIAC, n (%) | |
| Yes | 14 (25%) |
| No | 42 (75%) |
| Patients per study, n | |
| Study 1: Phase I for non-EIACs | 20 (14 at Phase II dose, 6 above |
| Study 2: Phase I for EIACs | 12 (all at Phase II dose) |
| Study 3: Phase II | 24 |