Table 1.
Patient baseline characteristics and demographics.
| Sapanisertib | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Dose-escalation phase | Expansion phase | ||||||||
| Characteristic | QD 2–7 mg (n = 31) |
QD × 5dQW 7–13 mg (n = 22) |
QD × 3dQW 6–20 mg (n = 33) |
QW 7–40 mg (n = 30) |
Total (n = 116) |
QD 5 mg (n = 39) |
QW 30 mg (n = 17) |
QW 40 mg (n = 26) |
Total (n = 82) |
| Median age, years (range) | 61 (24–75) | 62 (32–75) | 54 (36–87) | 57 (34–89) | 60 (24–89) | 61 (30–81) | 63 (32–76) | 65 (44–80) | 62 (30–81) |
| Male, n (%) | 15 (48) | 9 (41) | 11 (33) | 12 (40) | 47 (41) | 23 (59) | 11 (65) | 12 (46) | 46 (56) |
| Race, n (%) | |||||||||
| Asian | 1 (3) | 0 | 0 | 0 | 1 (1) | 1 (3) | 0 | 0 | 1 (1) |
| White | 28 (90) | 22 (100) | 30 (91) | 29 (97) | 109 (94) | 37 (95) | 17 (100) | 25 (96) | 79 (96) |
| Cancer diagnosis, n (%) | |||||||||
| Breast | 3 (10) | 1 (5) | 2 (6) | 2 (7) | 8 (7) | – | – | – | – |
| Colorectal | 6 (19) | 8 (36) | 7 (21) | 4 (13) | 25 (22) | – | – | – | – |
| Gastric | 0 | 0 | 1 (3) | 1 (3) | 2 (2) | – | – | – | – |
| Head and neck | 1 (3) | 1 (5) | 2 (6) | 1 (3) | 5 (4) | – | – | – | – |
| Lung (non-small-cell) | 0 | 1 (5) | 4 (12) | 3 (10) | 8 (7) | – | – | – | – |
| Melanoma | 1 (3) | 0 | 0 | 0 | 1 (1) | – | – | – | – |
| Ovarian | 2 (6) | 1 (5) | 4 (12) | 2 (7) | 9 (8) | – | – | – | – |
| Pancreatic | 2 (6) | 0 | 2 (6) | 1 (3) | 5 (4) | – | – | – | – |
| Prostate | 1 (3) | 0 | 1 (3) | 0 | 2 (2) | – | – | – | – |
| Renal | 2 (6) | 3 (14) | 1 (3) | 4 (13) | 10 (9) | 22 (56) | 10 (59) | 13 (50) | 45 (55) |
| RCC, TORC1i naïve | – | – | – | – | – | 8 (21) | 4 (24) | 8 (31) | 20 (24) |
| RCC, TORC1i failure | – | – | – | – | – | 14 (36) | 6 (35) | 5 (19) | 25 (30) |
| Endometrial | 3 (10) | 0 | 1 (3) | 4 (13) | 8 (7) | 11 (28) | 4 (24) | 6 (23) | 21 (26) |
| Bladder | – | – | – | – | – | 6 (15) | 3 (18) | 6 (23) | 15 (18) |
| Other | – | – | – | – | – | – | – | 1 (4)a | 1 (1) |
| Number of prior treatment regimens, median (range) | 3 (1–10) | 2 (0–5) | 4 (0–6) | 3 (0–10) | 3 (0–10) | 2 (0–7) | 2 (0–4) | 2 (0–8) | 2 (0–8) |
QD once daily, QD × 3dQW QD for 3 days on/4 days off QW, QD × 5dQW QD for 5 days on/2 days off QW, QW once weekly, TORC1i target of rapamycin complex 1 inhibitor therapy.
aPatient initially diagnosed with metastatic transitional cell carcinoma of the renal pelvis; re-review of the patient’s pathology slides revealed primary renal urothelial carcinoma.