Table 1.
Patient demographics and disease characteristics based on treatment group
| Characteristics | BEZ235 qd (N = 27) | BEZ235 bid | |||||
|---|---|---|---|---|---|---|---|
| 400 mg (n = 3) | 800 mg (n = 3) | 1000 mg (n = 8) | 1200 mg (n = 6) | 1400 mg (n = 7) | All patients (N = 27) | 400 mg (N = 8) | |
| Age, years, median (range) | 65 (52–69) | 62 (61–74) | 59 (31–70) | 65 (37–67) | 55 (38–74) | 62 (31–74) | 50 (36–74) |
| Sex, N (%) | |||||||
| Male | 0 | 2 (66.7) | 8 (100) | 4 (66.7) | 2 (28.6) | 16 (59.3) | 4 (50.0) |
| Female | 3 (100) | 1 (33.3) | 0 | 2 (33.3) | 5 (71.4) | 11 (40.7) | 4 (50.0) |
| ECOG PS, N (%) | |||||||
| 0 | 2 (66.7) | 0 | 4 (50.0) | 3 (50.0) | 2 (28.6) | 11 (40.7) | 3 (37.5) |
| 1 | 1 (33.3) | 3 (100) | 4 (50.0) | 3 (50.0) | 5 (71.4) | 16 (59.3) | 5 (62.5) |
| Primary site of cancer, N (%) | |||||||
| Rectum | 0 | 0 | 2 (25.0) | 1 (16.7) | 2 (28.6) | 5 (18.5) | 1 (12.5) |
| Lung | 0 | 0 | 1 (12.5) | 0 | 2 (28.6) | 3 (11.1) | 0 |
| Pancreas | 0 | 1 (33.3) | 0 | 0 | 1 (14.3) | 2 (7.4) | 2 (25.0) |
| Colon | 0 | 0 | 0 | 2 (33.3) | 0 | 2 (7.4) | 1 (12.5) |
| Bone | 1 (33.3) | 0 | 0 | 0 | 1 (14.3) | 2 (7.4) | 1 (12.5) |
| Soft tissue | 0 | 0 | 2 (25.0) | 0 | 0 | 2 (7.4) | 0 |
| Stomach | 0 | 0 | 1 (12.5) | 0 | 0 | 1 (3.7) | 2 (25.0) |
| Other | 1 (33.3) | 2 (66.7) | 1 (12.5) | 1 (16.7) | 1 (14.3) | 6 (22.2) | 1 (12.5) |
| Unknown | 1 (33.3) | 0 | 1 (12.5) | 2 (33.3) | 0 | 4 (14.8) | 0 |
| Number of prior regimens, N (%) | |||||||
| 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 1 (3.7) | 0 |
| 1–2 | 3 (100) | 2 (66.7) | 2 (25.0) | 4 (66.7) | 3 (42.9) | 14 (51.9) | 3 (37.5) |
| 3–4 | 0 | 0 | 6 (75.0) | 1 (16.7) | 1 (14.3) | 8 (29.6) | 3 (37.5) |
| ≥ 5 | 0 | 1 (33.3) | 0 | 1 (16.7) | 2 (28.6) | 4 (14.8) | 2 (25.0) |
bid twice daily, ECOG PS Eastern Cooperative Oncology Group Performance Status, qd once daily