Table 1.
Patient demographics in the phase II component of the DisrupTOR-1 study.
| Total (%) | Arm A (%) | Arm B (%) | p-value | |
|---|---|---|---|---|
| Sex | N=138 | N=69 | N=69 | 0.16 |
| Female | 33 (24) | 20 (29) | 13 (19) | |
| Male | 105 (76) | 49 (71) | 56 (81) | |
| Age (years) | 0.43 | |||
| Mean (SD) | 62 (9) | 62 (9) | 63 (9) | |
| Median | 63 | 61 | 64 | |
| Minimum | 40 | 45 | 40 | |
| Maximum | 84 | 82 | 84 | |
| Race | 0.46 | |||
| White | 120 (87) | 61 (88) | 59 (86) | |
| Black or African American | 6 (4) | 2 (3) | 4 (6) | |
| Asian | 10 (7) | 5 (7) | 5 (7) | |
| American Indian or Alaska | 1 (1) | 0 (0.00) | 1 (1) | |
| Unknown | 1 (1) | 1 (1) | 0 (0.00) | |
| Initial KPS | 0.46 | |||
| 100 | 54 (39) | 29 (42) | 25 (36) | |
| 90 | 47 (34) | 23 (33) | 24 (35) | |
| 80 | 28 (20) | 13 (19) | 15 (2) | |
| 70 | 9 (7) | 4 (6) | 5 (7) | |
| MSKCC Risk Group | 0.93 | |||
| Good | 33 (24) | 17 (24.64) | 16 (23.19) | |
| Intermediate | 92 (67) | 45 (65.22) | 47 (68.12) | |
| Poor | 13 (9) | 7 (10.14) | 6 (8.70) | |
| Metastatic Site | ||||
| Lung | 111 (80) | 57 (83) | 54 (78) | 0.52 |
| Liver | 26 (19) | 13 (19) | 13 (19) | >0.99 |
| Bone | 45 (33) | 21 (30) | 24 (35) | 0.59 |
| Brain | 8 (6) | 3 (4) | 5 (7) | 0.47 |
| Number of Prior Therapies | ||||
| 1 | 27 (20) | 14 (20) | 13 (19) | |
| 2 | 42 (30) | 24 (35) | 18 (26) | |
| 3 | 25 (18) | 10 (14) | 15 (22) | |
| ≥4 | 44 (32) | 21 (30) | 23 (33) |
(Note: Arm A = everolimus with BNC105P; Arm B = everolimus monotherapy.)