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) |