Table 1.
Patient Demographics and Baseline Characteristics.*
| Characteristic | Phase 1 (All Doses Combined; N=47) | Phase 2 (5 mg Twice a Day; N=45) |
|---|---|---|
| Age, median (IQR) — yr | 70.0 (61–73) | 69.0 (61–75) |
| Body mass index, median (IQR) — kg/m2 | 26.7 (24.8–28.6) | 25.8 (23.5–27.7) |
| ECOG performance status — no. (%) | ||
| 0 | 17 (36.2) | 10 (22.2) |
| 1 | 30 (63.8) | 35 (77.8) |
| PSA concentration, median (IQR) — μg/l | 126.0 (30.7–385.9) | 319.6 (137.9–768.5) |
| Gleason total score — no. (%) † | ||
| 7 | 14 (32.6) | 16 (38.1) |
| 8 | 13 (30.2) | 6 (14.3) |
| 9 | 14 (32.6) | 17 (40.5) |
| 10 | 0 | 3 (7.1) |
| Testosterone, median (IQR) — ng/dl | 3.8 (1.4–6.0) | 3.2 (1.1–6.5) |
| AR mutation — no. (%) | ||
| Yes | 20 (42.6) | 45 (100) |
| Prior lines of systemic therapy — no. (%) | ||
| 1 | 1 (2.1) | 0 |
| 2 | 2 (4.3) | 7 (15.6) |
| ≥3 | 44 (93.6) | 38 (84.4) |
| Select prior systemic therapies — no. (%) | ||
| Taxanes | ||
| Docetaxel | 44 (93.6) | 44 (97.8) |
| Cabazitaxel | 25 (53.2) | 31 (68.9) |
| Taxane naïve | 3 (6.4) | 0 |
| Abiraterone | 34 (72.3) | 38 (84.4) |
| Enzalutamide | 36 (76.6) | 31 (68.9) |
| Abiraterone and enzalutamide | 24 (51.1) | 25 (55.6) |
*
The full table can be found in Table S4. AR denotes androgen receptor gene; ECOG, Eastern Cooperative Oncology Group, with a score of 0 indicating fully active and a score of 1 restricted in strenuous activity; IQR, interquartile range; and PSA, prostate-specific antigen.
†
The percentage of patients with Gleason total score is calculated on the basis of patients with an available score (n=43 for phase 1 and n=42 for phase 2).