Table 3. Haematologic toxicity.
Leukopenia |
Neutropenia |
Anemia |
Thrombocytopenia |
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Dose level | G1 | G2 | G3 | G4 | G1 | G2 | G3 | G4 | G1 | G2 | G3 | G1 | G2 | G3 | G4 | Grade 3/4 toxicity (%) |
Phase I | ||||||||||||||||
1 (n=3) | 0 | 0 | 3 | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 100 |
2 (n=3) | 0 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 33 |
3 (n=2) | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 100 |
Phase II | ||||||||||||||||
2 (cycles=50)a | 6 | 19 | 18 | 1 | 9 | 9 | 22 | 6 | 17 | 17 | 10 | 4 | 8 | 4 | 1 | 62a |
1 (cycles=8) | 0 | 2 | 5 | 1 | 0 | 1 | 3 | 4 | 1 | 2 | 5 | 1 | 2 | 2 | 1 | 100 |
Total (cycles=58) | 6 | 21 | 23 | 2 | 9 | 10 | 25 | 10 | 18 | 19 | 15 | 5 | 10 | 6 | 2 | 67 |
Three patients were from the phase I study.