Table 1.
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.