|
Disposition Status, n (%)
|
25 mg BID (n = 8)
|
50 mg BID Cont’ (n = 18)
|
50 mg BID Int’ (n = 9)
|
75 mg Total Daily (n = 7)
|
100 mg BIDa (n = 1)
|
300 mg BIDa (n = 7)
|
Total (N = 50)
|
|---|
|
Patients who completed study treatment
|
1 (12.5)
|
0
|
1 (11.1)
|
0
|
0
|
0
|
2 (4.0)
|
|
Patients who discontinued study treatment
|
7 (87.5)
|
18 (100.0)
|
8 (88.9)
|
7 (100.0)
|
1 (100.0)
|
7 (100.0)
|
48 (96.0)
|
|
Primary reason for discontinuation from treatment/early terminationb
|
|
Adverse event
|
4 (50.0)
|
8 (44.4)
|
3 (33.3)
|
0
|
0
|
5 (71.4)
|
20 (40.0)
|
|
Disease progression
|
3 (37.5)
|
8 (44.4)
|
4 (44.4)
|
5 (71.4)
|
0
|
0
|
20 (40.0)
|
|
Consent withdrawn
|
0
|
1 (5.6)
|
1 (11.1)
|
2 (28.6)
|
0
|
0
|
4 (8.0)
|
|
Sponsor decision
|
0
|
0
|
0
|
0
|
1 (100.0)
|
2 (28.6)
|
3 (6.0)
|
|
Investigator decision
|
0
|
1 (5.6)
|
0
|
0
|
0
|
0
|
1 (2.0)
|
- ALT alanine aminotransferase, AST aspartate aminotransferase, BID twice daily, cont’ continuous, int’ intermittent
- a All patients who received epacadostat 100 mg BID and 300 mg BID discontinued treatment after 5 of these patients developed clinically significant ALT/AST elevations. These doses were not re-explored in this study after protocol amendment to evaluate lower epacadostat doses
- b No patients discontinued or terminated study treatment early because of death, lost to follow-up, noncompliance, patient decision, protocol deviation, or termination of the clinical study by the sponsor
