Table 4.
Grade 3/4 laboratory abnormalities, any causalitya
| Laboratory abnormality, grade 3/4, n (%) | Tivozanib 0.5 mg/d, temsirolimus 15 mg/week (n = 5) |
Tivozanib 1.0 mg/d, temsirolimus 15 mg/week (n = 4) |
Tivozanib 1.5 mg/d, temsirolimus 15 mg/week (n = 3) |
Tivozanib 1.5 mg/d, temsirolimus 25 mg/week (n = 15)b |
Total (N = 27) |
|---|---|---|---|---|---|
| Hyperglycaemia | 1 | 1 | 0 | 2 | 4 (15) |
| Hypophosphatemia | 0 | 0 | 1 | 3 | 4 (15) |
| Elevated GGT | 1 | 0 | 0 | 2 | 3 (11) |
| Lymphopenia | 0 | 1 | 0 | 2 | 3 (11) |
| Thrombocytopenia | 1 | 0 | 0 | 2 | 3 (11) |
| Hypertriglyceridemia | 0 | 0 | 0 | 3 | 3 (11) |
| Hypokalemia | 0 | 0 | 0 | 2 | 2 (7) |
| Hyponatremia | 0 | 1 | 0 | 1 | 2 (7) |
| Elevated alkaline phosphatase | 1 | 0 | 0 | 0 | 1 (4) |
| Hypermagnesemia | 0 | 0 | 0 | 1 | 1 (4) |
| Neutropenia | 0 | 0 | 1 | 0 | 1 (4) |
| Elevated uric acid | 0 | 0 | 0 | 1 | 1 (4) |
GGT, gamma-glutamyl transpeptidase; RP2D, recommended phase II dose.
a
Patients with laboratory parameters that shifted from grade ≤2 severity to grade ≥3 severity.
b
Includes the expansion cohort at the RP2D.