Table 2.
All grades of treatment-related adverse events in at least two patients who received CEP-9722 alone or combined with temolozomide
| N patients treated (%) | CEP-9722 dose level (mg/day) | Total | ||||
|---|---|---|---|---|---|---|
| 150 3 |
300 6 |
500 3 |
750 11 |
1,000 3 |
26 | |
| Cycle 1: single-agent CEP-9722 | ||||||
| Nausea | 0 | 1 (17) | 1 (33) | 8 (73) | 2 (67) | 12 (46) |
| Diarrhea | 0 | 0 | 0 | 5 (45) | 2 (67) | 7 (27) |
| Vomiting | 0 | 1 (17) | 0 | 4 (36) | 2 (67) | 7 (27) |
| Abdominal pain | 0 | 0 | 0 | 2 (18) | 0 | 2 (8) |
| Constipation | 0 | 0 | 0 | 2 (18) | 0 | 2 (8) |
| Asthenia | 0 | 1 (17) | 0 | 3 (27) | 1 (33) | 5 (19) |
| Fatigue | 1 (33) | 1 (17) | 0 | 2 (18) | 0 | 4 (15) |
| Blood creatinine phosphokinase increased | 0 | 0 | 0 | 1 (9) | 1 (33) | 2 (8) |
| Anorexia | 0 | 0 | 0 | 1 (9) | 2 (67) | 3 (12) |
| Headache | 0 | 1 (17) | 2 (67) | 5 (45) | 2 (67) | 10 (38) |
| Cycles ≥ 2: CEP-9722 combined with temozolomide | ||||||
| Leukopenia | 1 (33) | 0 | 0 | 2 (18) | 0 | 3 (12) |
| Anemia | 0 | 0 | 1 (33) | 1 (9) | 0 | 2 (8) |
| Neutropenia | 1 (33) | 0 | 0 | 1 (9) | 0 | 2 (8) |
| Thrombocytopenia | 1 (33) | 0 | 0 | 1 (9) | 0 | 2 (8) |
| Nausea | 1 (33) | 3 (50) | 1 (33) | 8 (73) | 2 (67) | 15 (58) |
| Vomiting | 1 (33) | 1 (17) | 1 (33) | 8 (73) | 2 (67) | 13 (50) |
| Diarrhea | 0 | 0 | 0 | 3 (27) | 2 (67) | 5 (19) |
| Constipation | 0 | 0 | 0 | 2 (18) | 1 (33) | 3 (12) |
| Dyspepsia | 0 | 0 | 0 | 2 (18) | 0 | 2 (8) |
| Asthenia | 0 | 0 | 2 (67) | 4 (36) | 0 | 6 (23) |
| Fatigue | 0 | 1 (17) | 0 | 4 (36) | 1 | 6 (23) |
| Gamma-glutamyltransferase increased | 0 | 0 | 1 (33) | 2 (18) | 0 | 3 (12) |
| Hemoglobin decreased | 0 | 1 (17) | 0 | 2 (18) | 0 | 3 (12) |
| Weight decreased | 0 | 1 (17) | 0 | 1 (9) | 1 (33) | 3 (12) |
| Aspartate aminotransferase increased | 0 | 0 | 1 (33) | 1 (9) | 0 | 2 (8) |
| Anorexia | 0 | 1 (17) | 0 | 1 (9) | 2 (67) | 4 (15) |
| Headache | 0 | 2 (33) | 2 (67) | 5 (45) | 2 (67) | 11 (42) |