Table 2:
Adverse events (AE) seen in >10% of patients that are possibly, probably, or definitively attributed to at least one of the study drugs (ganitumab or dasatinib) across all 28 cycles in 13 patients (highest grade reported for each patient across all treatment cycles)
| Dose level 1 (N) | Dose level 2 (N) | Total # patients | ||||||
|---|---|---|---|---|---|---|---|---|
| Attributed to | Grade | Grade | ||||||
| 1 | 2 | 3 | 1 | 2 | 3 | |||
| Non- hematological toxicities | ||||||||
| Dasatinib only | Abdominal distension | 2 | 1 | 1 | 4 | |||
| Diarrhea | 2 | 1 | 1 | 4 | ||||
| Edema | 3 | 3 | ||||||
| Hypocalcemia | 1 | 3 | 1 | 1 | 6 | |||
| Hypokalemia | 1 | 1 | 1 | 1 | 4 | |||
| Hypomagnesemia | 2 | 2 | ||||||
| Hypophosphatemia | 2 | 3 | 1 | 1 | 7 | |||
| Pericardial effusion | 2 | 1 | 3 | |||||
| Rash, acneiform | 1 | 2 | 3 | |||||
| Dasatinib and/or ganitumab * | Abdominal pain | 1 | 1 | 2 | ||||
| ALT increase | 3 | 3 | ||||||
| Anorexia | 2 | 2 | 4 | |||||
| AST increase | 3 | 2 | 5 | |||||
| Cough | 2 | 2 | ||||||
| Dyspnea | 1 | 1 | 1 | 3 | ||||
| Fatigue | 2 | 3 | 5 | |||||
| Headache | 1 | 1 | 1 | 3 | ||||
| Hyponatremia | 2 | 1 | 3 | |||||
| Nausea | 3 | 1 | 1 | 1 | 6 | |||
| Pleural effusion | 1 | 2 | 3 | |||||
| Pleuritic pain | 2 | 2 | ||||||
| Vomiting | 3 | 1 | 1 | 5 | ||||
| Hematological toxicities | ||||||||
| Dasatinib and/or ganitumab * | Anemia | 1 | 5 | 2 | 1 | 1 | 10 | |
| Lymphocyte count decrease | 1 | 3 | 1 | 1 | 2 | 8 | ||
| Neutrophil count decrease | 1 | 1 | 2 | |||||
| Platelet count decrease | 6 | 1 | 3 | 1 | 1 | 12 | ||
| White blood cell decrease | 1 | 1 | 2 | 4 | ||||
N= number of patients, AST = aspartate amino transferase, ALT= alanine aminotransferase
*
At least 1 patient with toxicity attributed to dasatinib only, ganitumab only, or both. AEs only attributed to ganitumab included hypertension, hypotension, hypoxia, and tinnitus (N= 1 for all AEs).