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Table 1 Patient Disposition

From: Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma

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 Consent withdrawn 0 1 (5.6) 1 (11.1) 2 (28.6) 0 0 4 (8.0)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)
  1. ALT alanine aminotransferase, AST aspartate aminotransferase, BID twice daily, cont’ continuous, int’ intermittent
  2. 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
  3. 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