Patient Disposition
| 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| Consent withdrawn | 0 | 1 (5.6) | 1 (11.1) | 2 (28.6) | 0 | 0 | 4 (8.0) |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