Table 1 Baseline characteristics and primary diagnosis details by cohort in the total intent-to-treat population

From: Defactinib with avutometinib in patients with solid tumors: the phase 1 FRAME trial

 

Dose escalation (n = 12)

KRASM NSCLC (n = 21)

LGSOC (n = 19)

CRC (n = 10)

PC (n = 10)

EOC (n = 2)

KRASG12V NSCLC (n = 10)

ST biopsy (n = 7)

Overall (N = 91)

Sex, n (%)

 Female

9 (75.0)

13 (61.9)

19 (100)

4 (40.0)

2 (20.0)

2 (100)

5 (50.0)

3 (42.9)

57 (62.6)

 Male

3 (25.0)

8 (38.1)

0

6 (60.0)

8 (80.0)

0

5 (50.0)

4 (57.1)

34 (37.4)

Ethnicity, n (%)

 White: British

7 (58.3)

19 (90.5)

17 (89.5)

9 (90.0)

7 (70.0)

2 (100)

9 (90.0)

7 (100)

77 (84.6)

 White: Irish

1 (8.3)

0

0

1 (10.0)

1 (10.0)

0

0

0

3 (3.3)

 Asian or Asian British: Indian

0

0

0

0

0

0

1 (10.0)

0

1 (1.1)

 Black or Black British: Caribbean

0

0

1 (5.3)

0

0

0

0

0

1 (1.1)

 Other

4 (33.3)

2 (9.5)

1 (5.3)

0

2 (20.0)

0

0

0

9 (9.9)

Age (<55 and ≥56), n (%)

 <56

7 (58.3)

6 (28.6)

8 (42.1)

5 (50.0)

2 (20.0)

0

0

2 (28.6)

30 (33.0)

 ≥56

5 (41.7)

15 (71.4)

11 (57.9)

5 (50.0)

8 (80.0)

2 (100)

10 (100)

5 (71.4)

61 (67.0)

BMI, median

24.0 (23.0–26.3)

23.6 (20.8–28.3)

26.5 (23.2–30.4)

26.1 (24.7–27.8)

22.9 (22.1–24.9)

47.6 (47.6–47.6)

24.7 (23.9–35.2)

24.0 (22.9–28.5)

24.8 (22.4–28.1)

 (Missing)

0

2

1

1

1

1

0

0

6

ECOG status, n (%)

 0

2 (16.7)

2 (9.5)

2 (11.1)

3 (30.0)

0

0

1 (10.0)

1 (16.7)

11 (12.4)

 1

10 (83.3)

19 (90.5)

16 (88.9)

7 (70.0)

10 (100)

2 (100)

9 (90.0)

5 (83.3)

78 (87.6)

 (Missing)

0

0

1

0

0

0

0

1

2

KRAS status, n (%)

 Mutant

9 (75.0)

21 (100)

11 (57.9)

10 (100)

5 (50.0)

2 (100)

10 (100)

7 (100)

75 (82.4)

 Wild-type

0

0

1 (5.3)

0

0

0

0

0

1 (1.1)

 Not tested

3 (25.0)

0

7 (36.8)

0

5 (50.0)

0

0

0

15 (16.5)

  1. Of the 91 patients, 90 received at least one dose of treatment on trial. BMI, body mass index; ECOG, European Cooperative Oncology Group.