Table 3.
Adverse Events Reported in ≥20% of Patients
| Adverse Event, n (%) | Dose Level M1 (n = 3) | Dose Level M2A (n = 5) | Dose Level M2B (n = 4) | Dose Level M3 (n = 4) | Dose Level TI (n = 5) | Total (n = 21) | |
|---|---|---|---|---|---|---|---|
| Any Grade | Grade ≥3 | ||||||
| Any Adverse Event | 3 (100) | 5 (100) | 4 (100) | 4 (100) | 5 (100) | 21 (100) | 15 (71.4) |
| Nausea | 1 (33.3) | 4 (80.0) | 3 (75.0) | 3 (75.0) | 3 (60.0) | 14 (66.7) | - |
| Diarrhea | 1 (33.3) | 2 (40.0) | 3 (75.0) | 1 (25.0) | 4 (80.0) | 11 (52.4) | - |
| Fatigue | 2 (66.7) | 4 (80.0) | 2 (50.0) | 1 (25.0) | 2 (40.0) | 11 (52.4) | 2 (9.5) |
| Decreased Appetite | 0(0) | 2 (40.0) | 2 (50.0) | 1 (25.0) | 2 (40.0) | 7 (33.3) | - |
| Dizziness | 2 (66.7) | 1 (20.0) | 0(0) | 1 (25.0) | 2 (40.0) | 6 (28.6) | 6 (28.6) |
| Vomiting | 0(0) | 1 (20.0) | 1 (25.0) | 1 (25.0) | 2 (40.0) | 5 (23.8) | - |
| Pyrexia | 0(0) | 3 (60.0) | 2 (50.0) | 0(0) | 0(0) | 5 (23.8) | - |
| Cough | 0(0) | 1 (20.0) | 1 (25.0) | 2 (50.0) | 1 (20.0) | 5 (23.8) | - |
| Dyspnea | 0(0) | 2 (40.0) | 1 (25.0) | 0(0) | 2 (40.0) | 5 (23.8) | - |
| Dry Skin | 0(0) | 2 (40.0) | 2 (50.0) | 1 (25.0) | 0(0) | 5 (23.8) | - |
| Musculoskeletal Chest Pain | 0(0) | 2 (40.0) | 2 (50.0) | 0(0) | 1 (20.0) | 5 (23.8) | - |
| Amylase Increased | 0(0) | 2 (40.0) | 2 (50.0) | 0(0) | 1 (20.0) | 5 (23.8) | 2 (9.5) |
| AST Increased | 0(0) | 3 (60.0) | 0(0) | 0(0) | 2 (40.0) | 5 (23.8) | - |
| Anemia | 0(0) | 3 (60.0) | 1 (25.0) | 0(0) | 1 (20.0) | 5 (23.8) | - |
Data are presented as n (%). Most cases of nausea, diarrhea, and fatigue, as well as adverse events of decreased appetite, dizziness, and increased AST, were considered by the investigator to be related to momelotinib and trametinib; cases of dry skin were considered related to trametinib. Dose level M1: momelotinib 100 mg q.d. with trametinib 1.0 mg q.d.; dose level M2A: momelotinib 200 mg q.d. with trametinib 1.0 mg q.d.; dose level M2B: momelotinib 100 mg b.i.d. with trametinib 1.0 mg q.d.; dose level M3: momelotinib 150 mg b.i.d. with trametinib 1.0 mg q.d.; dose level TI: momelotinib 150 mg b.i.d. with trametinib 1.5 mg q.d.
Abbreviations: AST = aspartate aminotransferase; b.i.d. = twice daily; q.d. = once daily.