Table 1 Patient baseline characteristics and demographics.

From: Phase 1 study of mTORC1/2 inhibitor sapanisertib (TAK-228) in advanced solid tumours, with an expansion phase in renal, endometrial or bladder cancer

 

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)

  1. 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.
  2. 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.
Back to article page