TABLE 3.
TEAEs occurring in ≥15% of patients overall by dose level
| Any grade | Grade ≥3 | |||||||
|---|---|---|---|---|---|---|---|---|
| 7 mg QD n = 3 | 12 mg QD n = 3 | 20 mg QD n = 3 | 35 mg QD n = 8 | 60 mg QD n = 7 | 80 mg QD n = 3 | Overall n = 27 | Overall n = 27 | |
| TEAE | Number (%) of patients | |||||||
| Platelet count decrease | 0 (0.0) | 1 (33.3) | 2 (66.7)a | 2 (25.0) | 6 (85.7)a | 2 (66.7) | 13 (48.2)b | 5 (18.5)a |
| Decreased appetite | 1 (33.3) | 1 (33.3) | 1 (33.3) | 3 (35.7) | 1 (14.3) | 2 (66.7) | 9 (33.3) | 0 (0.0) |
| Anemia | 1 (33.3) | 1 (33.3) | 2 (66.7) | 3 (37.5) | 1 (14.3) | 0 (0.0) | 8 (29.6) | 4 (14.8) |
| Nausea | 1 (33.3) | 1 (33.3) | 0 (0.0) | 3 (37.5) | 3 (42.9) | 0 (0.0) | 8 (29.6) | 0 (0.0) |
| AST increase | 0 (0.0) | 1 (33.3) | 1 (33.3) | 4 (50.0) | 2 (28.6) | 0 (0.0) | 8 (29.6) | 1 (3.7) |
| Fatigue | 0 (0.0) | 1 (33.3) | 2 (66.7) | 2 (25.0) | 1 (14.3) | 1 (33.3) | 7 (25.9) | 0 (0.0) |
| ALT increase | 0 (0.0) | 1 (33.3) | 0 (0.0) | 2 (25.0) | 3 (42.9) | 0 (0.0) | 6 (22.2) | 2 (7.4) |
| Headache | 0 (0.0) | 0 (0.0) | 1 (33.3) | 2 (25.0) | 1 (14.3) | 2 (66.7) | 6 (22.2) | 0 (0.0) |
| Abdominal pain | 1 (33.3) | 1 (33.3) | 1 (33.3) | 1 (12.5) | 0 (0.0) | 1 (33.3) | 5 (18.5) | 0 (0.0) |
| Constipation | 0 (0.0) | 1 (33.3) | 1 (33.3) | 2 (25.0) | 0 (0.0) | 1 (33.3) | 5 (18.5) | 0 (0.0) |
| Disease progression | 0 (0.0) | 1 (33.3) | 2 (66.7) | 2 (25.0) | 0 (0.0) | 0 (0.0) | 5 (18.5) | 5 (18.5) |
| Weight decrease | 0 (0.0) | 0 (0.0) | 2 (66.7) | 2 (25.0) | 1 (14.3) | 0 (0.0) | 5 (18.5) | 0 (0.0) |
| Dizziness | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (28.6) | 2 (66.7) | 5 (18.5) | 0 (0.0) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; QD, once daily; TEAE, treatment-emergent adverse event.
aIncludes thrombocytopenia (n = 1).
bIncludes thrombocytopenia (n = 2).