Table 1.
Summary of Adverse events
| Grade
|
|||||||
|---|---|---|---|---|---|---|---|
|
DL1 (125mg) (n=4) |
DL2 (175mg)(n=4) |
DL3 (150mg) (n=4) |
|||||
| Adverse Events | 2 | 3 | 2 | 3 | 2 | 3 | Total (%) |
| Gastrointestinal | |||||||
| Diarrhea¥ | 1 | – | 3 | 3 | 1 | 1 | 9 (75) |
| Nausea | 1 | – | 1 | – | 1 | – | 3 (25) |
| Vomiting | 1 | – | 1 | – | – | – | 2 (17) |
| Flatulence | 1 | – | – | – | – | – | 1 (0.1) |
| Constipation | – | – | – | – | 1 | – | 1 (0.1) |
|
| |||||||
| Hematologic | |||||||
| Neutropenia | – | 1 | 1 | 2 | – | – | 4 (33) |
| Anemia | – | – | 1 | – | – | – | 1 (0.1) |
|
| |||||||
| Metabolism and nutritional | |||||||
| Hypokalemia | – | 1 | – | 1 | – | – | 2 (17) |
| Anorexia | 1 | – | – | – | – | – | 1 (0.1) |
| hypocalcemia | – | – | – | – | 2 | 1 | 3 (25) |
| Hyperglycemia | – | – | – | – | – | 1 | 1 (0.1) |
|
| |||||||
| Skin and subcutaneous | |||||||
| Palmar-plantar erthrodysesthesia syndrome | – | – | – | – | 1 | – | 1 (0.1) |
| Maculopapular rash | 1 | – | – | – | – | – | 1 (0.1) |
|
| |||||||
| Other | |||||||
| Fatigue | – | – | 2 | – | 2 | – | 4 (33) |
| Weight loss | 1 | – | 1 | – | – | – | 2 (17) |
| Dehydration | – | – | 1 | – | – | – | 1 (0.1) |
| Urinary tract infection | 1 | – | 1 | – | 1 | – | 3 (25) |
| Depression | 1 | – | – | – | – | – | 1 (0.1) |
| Sinus pain | – | – | – | – | – | 1 | 1 (0.1) |
| Infusion related reaction | 1 | – | – | – | – | – | 1 (0.1) |
|
| |||||||
| 10 | 2 | 12 | 6 | 9 | 4 | 43 | |
¥
Two patients experienced DLTs of Grade 3 diarrhea during treatment at DL2. One of these patients developed initial Grade 3 at this dose level which promptly resolved to Grade 2 with immodium, but upon resuming therapy subsequently developed recurrent Grade 3 diarrhea meeting DLT criteria.