Table 2 DLTs and grade 3 adverse events.

From: First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours

 

1A-1

0.6 mg/kga (n = 3)

1A-2

1.3 mg/kga (n = 7)

1A-3

1.5 mg/kg (n = 5)

1A-4

2 mg/kg (n = 6)

1B-1

1.1 mg/kg (n = 10)

1B-2

1.4 mg/kg (n = 4)

Total (n = 35)

 

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

SAEs

 

2 (29)

2 (40)

3 (50)

3 (30)

4 (100)

14 (40)

DLTs

 

1 (14)

    

1 (2.9)

Related SAEs

   

2 (33)

 

1 (25)

3 (8.6)

Grade ≥ 3 AEs

 

3 (43)

2 (40)

4 (67)

6 (60)

4 (100)

19 (54)

AEs leading to study discontinuation

1 (33)

 

2 (40)

1 (17)

3 (30)

2 (50)

9 (26)

AEs leading to dose reduction

   

2 (33)

1 (10)

1 (25)

4 (11)

AEs leading to dosing interruption

2 (67)

4 (57)

2 (40)

5 (83)

4 (40)

2 (50)

19 (54)

  1. aCohorts 1A-1 and 1A-2 were given the doses 50 and 100 mg, respectively, presented in Table 2 as cohort average in mg/kg. The range of doses in cohort 1A-1 was 0.1–0.7 and in 1A-2 was 0.9–1.9 mg/kg.
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