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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 Consent withdrawn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