TABLE 2.
Summary of treatment-related AEs (NCI CTCAE grades) occurring >10% in patients of all groups.
| Dose levels | 50 mg (N = 3) | 100 mg (N = 3) | 150 mg (N = 3) | 220 mg (N = 3) | 300 mg (N = 6) | 350 mg (N = 4) | 400 mg (N = 3) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AEs, n | Grade1 | Grade2 | Grade3 | Grade1 | Grade2 | Grade3 | Grade1 | Grade2 | Grade3 | Grade1 | Grade2 | Grade3 | Grade1 | Grade2 | Grade3 | Grade1 | Grade2 | Grade3 | Grade1 | Grade2 | Grade3 |
| Acne-like rash | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 1 | 0 | 6 | 0 | 0 | 1 | 2 | 0 | 3 | 0 | 0 |
| Paronychia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 2 | 0 | 2 | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 0 |
| Diarrhea | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 1 | 1 | 1 | 3 | 0 | 0 |
| Anemia | 0 | 1 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Hand-foot skin reaction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 0 | 2 | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 0 |
| Stomatitis | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 4 | 0 | 1 | 1 | 0 | 1 | 1 | 0 |
| Decreased lymphocyte | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 0 |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
| Hypoalbuminemia | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 3 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Weight loss | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 2 | 0 | 2 | 0 | 0 | 0 | 1 | 0 |
| Hematuria | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Hyperglycemia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Emesis | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Elevated alanine aminotransferase | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Decreased total protein | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Proteinuria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Xerostomia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Elevated aspartate aminotransferase | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
NOTE: No treatment-related Grade 4–5 AEs were observed in all dose cohorts during the study.
AE, adverse event; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.