Table 2.
Treatment-related grade ≥ 3 and all grade toxicities by dose level.
| All Patients (N = 30) |
Level 1 (n = 3) |
Level 2 (n = 3) |
Level 3 (n = 7) |
Level 4 (n = 5) |
Expansion (n = 12) |
|
|---|---|---|---|---|---|---|
| Any Grade ≥ 3 AE | 24 (80%) | 2 (67%) | 2 (67%) | 4 (57%) | 5 (100%) | 11 (92%) |
| Hematologic toxicity | ||||||
| Neutrophil count decreased | 18 (60%) | 2 (67%) | 2 (67%) | 3 (43%) | 5 (100%) | 6 (50%) |
| White blood cell decreased | 15 (50%) | - | 1 (33%) | 2 (29%) | 5 (100%) | 7 (58%) |
| Lymphocyte count decreased | 7 (23%) | - | - | 2 (29%) | 2 (40%) | 3 (25%) |
| Anemia | 7 (23%) | - | - | 2 (29%) | 2 (40%) | 3 (25%) |
| Platelet count decreased | 4 (13%) | - | - | 2 (29%) | - | 2 (17%) |
| Other | ||||||
| Nausea | 2 (7%) | - | - | - | 1 (20%) | 1 (8%) |
| Fatigue | 1 (3%) | - | - | - | 1 (20%) | - |
| Vomiting | 1 (3%) | - | - | - | 1 (20%) | - |
| Dehydration | 1 (3%) | - | - | - | - | 1 (8%) |
| Hypophosphatemia | 1 (3%) | - | - | - | - | 1 (8%) |
| Febrile neutropenia | 1 (3%) | - | - | - | 1 (8%) | |
| Any grade AE | 28 (93%) | 2 (67%) | 3 (100%) | 6 (86%) | 5 (100%) | 12 (100%) |
| Hematologic toxicity | ||||||
| Neutrophil count decreased | 24 (80%) | 2 (67%) | 3 (100%) | 4 (57%) | 5 (100%) | 10 (83%) |
| Platelet count decreased | 22 (73%) | 1 (33%) | 3 (100%) | 4 (57%) | 4 (80%) | 10 (83%) |
| Lymphocyte count decreased | 11 (37%) | - | - | 2 (29%) | 2 (40%) | 7 (58%) |
| White blood cell decreased | 22 (73%) | - | 3 (100%) | 4 (57%) | 5 (100%) | 10 (83%) |
| Anemia | 20 (67%) | - | 3 (100%) | 4 (57%) | 4 (80%) | 9 (75%) |
| Constitutional | ||||||
| Myalgia | 3 (10%) | - | 1 (33%) | - | - | 2 (17%) |
| Anorexia | 3 (10%) | - | - | 1 (14%) | - | 2 (17%) |
| Hot flashes | 4 (13%) | - | 1 (33%) | 1 (14%) | - | 2 (17%) |
| Fatigue | 18 (60%) | - | 3 (100%) | 3 (43%) | 4 (80%) | 8 (67%) |
| GI symptoms | ||||||
| Nausea | 16 (53%) | - | 3 (100%) | 2 (29%) | 1 (20%) | 10 (83%) |
| Diarrhea | 5 (17%) | - | 2 (67%) | - | - | 3 (25%) |
| Vomiting | 4 (13%) | - | - | - | 1 (20%) | 3 (25%) |
| Dysgeusia | 2 (7%) | - | 1 (33%) | 1 (14%) | - | - |
| AST increased | 3 (10%) | - | - | 1 (14%) | - | 2 (17%) |
| ALT increased | 4 (13%) | - | - | 1 (14%) | - | 3 (25%) |
| Electrolytes | ||||||
| Hypophosphatemia | 4 (13%) | - | - | 1 (14%) | - | 3 (25%) |
| Hyponatremia | 2 (7%) | - | 1 (33%) | 1 (14%) | - | - |
| Hyperglycemia | 2 (7%) | - | 1 (33%) | 1 (14%) | - | - |
| Hypocalcemia | 3 (10%) | - | 1 (33%) | 1 (14%) | - | 1 (8%) |
| Neurologic | ||||||
| Headache | 3 (10%) | - | - | 1 (14%) | - | 2 (17%) |
| Peripheral sensory neuropathy | 3 (10%) | - | - | 1 (14%) | - | 2 (17%) |
| Skin/soft tissue | ||||||
| Bruising | 2 (7%) | - | 1 (33%) | - | - | 1 (8%) |
| Rash maculo-papular | 2 (7%) | - | 1 (33%) | 1 (14%) | - | - |
Only adverse event possibly, probably, or definitely related to treatment were listed.