Table 3.
Incidence of toxicities in cycle 1
| Adverse event | Dose level | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade of adverse event | 1 (n = 3) | 2 (n = 3) | 3 (n = 6) | 4 (n = 8) | 5 (n = 5) | |||||||||||||||
| 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
| Blood/bone marrow | ||||||||||||||||||||
| Hemoglobin | 1 | 1 | 1 | 1 | 4 | 1* | 3 | 3 | 1 | 3 | 2 | |||||||||
| Neutrophils/granulocytes | 1 | 1 | 1 | 1 | 2 | 1* | 2 | 1 | 3 | 1# | ||||||||||
| Platelets | 1 | |||||||||||||||||||
| Constitutional symptoms | ||||||||||||||||||||
| Fatigue/malaise | 1 | 1 | 1 | 1 | 2 | 1 | 1* | 2 | 2 | |||||||||||
| Cardiovascular | ||||||||||||||||||||
| Hypotension | 1 | 2 | ||||||||||||||||||
| Gastrointestinal | ||||||||||||||||||||
| Anorexia | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||||||
| Dehydration | 1** | 1# | ||||||||||||||||||
| Diarrhea | 2 | 1 | 1 | 2 | 2 | 1 | 1 | 2δ# | ||||||||||||
| Nausea/vomiting | 1 | 2 | 1 | 1 | 1 | 2 | 1 | 1** | 2 | 1 | 2++ | |||||||||
| Stomatitis | 1 | 2 | ||||||||||||||||||
| Metabolic/laboratory | ||||||||||||||||||||
| Hyperglycemia | 2 | 1 | 1 | 1 | 2 | 1 | 3 | |||||||||||||
| Hypocalcemia | 2 | 1 | 2 | |||||||||||||||||
| Hypokalemia | 1 | 2 | 1# | |||||||||||||||||
| Hypophosphatemia | 1 | 1 | 1++ | |||||||||||||||||
| Pain | 1 | 3 | 1 | 1 | 1 | 1 | 1 | |||||||||||||
| Pulmonary | ||||||||||||||||||||
| Dyspnea | 1 | 1* | 1 | |||||||||||||||||
* Dose Level 3: One patient had grade 3 dyspnea (DLT) with grade 3 fatigue, anemia and neutropenia
** Dose Level 4: One patient had grade 3 dehydration (DLT) and grade 4 vomiting
Dose Level 5: δ One patient had grade 3 diarrhea (DLT), # one patient had grade 3 diarrhea (DLT) with grade 3 dehydration, hypokalemia, and neutropenia, and ++ one patient had grade 3 hypophosphatemia (DLT) and grade 3 nausea/vomiting