TABLE 3.
Hematologic and non-hematologic non-DLTsa,b observed during cycle 1 in evaluable patients across all dose levels (N=25)
| Dose Level and Toxicity Grade, No. (%) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| All Dose Levels (N=25) | Dose Level 1 (N=6) | Dose Level 2 (N=5) | Dose Level 3 (N=4) | Dose Level 4 (N=10) | ||||||
| Toxicity Type | All | ≥ Grade 3 | All | ≥ Grade 3 | All | ≥ Grade 3 | All | ≥ Grade 3 | All | ≥ Grade 3 |
| Neutrophil count decreased | 25 (100) | 25 (100) | 6 (100) | 6 (100) | 5 (100) | 5 (100) | 4 (100) | 4 (100) | 10 (100) | 10 (100) |
| White blood cell decreased | 24 (96) | 17 (68) | 5 (83) | 4 (67) | 5 (100) | 3 (60) | 4 (100) | 3 (75) | 10 (100) | 7 (70) |
| Platelet count decreased | 21 (84) | 6 (24) | 4 (67) | 1 (17) | 5 (100) | 2 (40) | 4 (100) | 2 (50) | 8 (80) | 1 (10) |
| Anemia | 19 (76) | 3 (12) | 5 (83) | 0 (0) | 3 (60) | 1 (20) | 3 (75) | 1 (25) | 8 (80) | 1 (10) |
| Lymphocyte count decreased | 12 (48) | 6 (24) | 3 (50) | 2 (33) | 2 (40) | 0 (0) | 2 (50) | 2 (50) | 5 (50) | 2 (20) |
| Electrocardiogram QT corrected interval prolonged | 9 (36) | 0 (0) | 2 (33) | 0 (0) | 1 (20) | 0 (0) | 2 (50) | 0 (0) | 4 (40) | 0 (0) |
| Fatigue | 6 (24) | 0 (0) | 0 (0) | 0 (0) | 2 (40) | 0 (0) | 2 (50) | 0 (0) | 2 (20) | 0 (0) |
| Vomiting | 6 (24) | 0 (0) | 1 (17) | 0 (0) | 1 (20) | 0 (0) | 0 (0) | 0 (0) | 4 (40) | 0 (0) |
| Alanine aminotransferase increased | 5 (20) | 1 (4) | 2 (33) | 0 (0) | 2 (40) | 1 (20) | 0 (0) | 0 (0) | 1 (10) | 0 (0) |
| Hypokalemia | 5 (20) | 0 (0) | 0 (0) | 0 (0) | 2 (40) | 0 (0) | 1 (25) | 0 (0) | 2 (20) | 0 (0) |
| Nausea | 5 (20) | 0 (0) | 1 (17) | 0 (0) | 1 (20) | 0 (0) | 0 (0) | 0 (0) | 3 (30) | 0 (0) |
| Aspartate aminotransferase increased | 4 (16) | 0 (0) | 0 (0) | 0 (0) | 3 (60) | 0 (0) | 0 (0) | 0 (0) | 1 (10) | 0 (0) |
| Diarrhea | 4 (16) | 0 (0) | 2 (33) | 0 (0) | 1 (20) | 0 (0) | 0 (0) | 0 (0) | 1 (10) | 0 (0) |
| Hypophosphatemia | 4 (16) | 0 (0) | 1 (17) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (30) | 0 (0) |
| Anorexia | 3 (12) | 0 (0) | 2 (33) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (10) | 0 (0) |
| Headache | 3 (12) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (25) | 0 (0) | 2 (20) | 0 (0) |
| Infusion-related reaction | 3 (12) | 0 (0) | 1 (17) | 0 (0) | 1 (20) | 0 (0) | 0 (0) | 0 (0) | 1 (10) | 0 (0) |
| Myalgia | 3 (12) | 0 (0) | 0 (0) | 0 (0) | 1 (20) | 0 (0) | 0 (0) | 0 (0) | 2 (20) | 0 (0) |
Abbreviation: DLT= dose-limiting toxicity; No.= number; WBC= white blood cell
a
Toxicities occurring in >10% of evaluable patients
b
Includes toxicities attributed as possibly, probably, or definitely related to prexasertib