Table 4.
Treatment-Related Side Effects per Dose Level
| Dose Level (mg) |
||||||||
|---|---|---|---|---|---|---|---|---|
| Toxicity | 5 (n=1) |
10 (n=1) |
20 (n=1)a |
40 (n=1) |
80 (n=1) |
160 (n=1) |
320 (n=6) |
150 (n=7) |
| Neutropenia | G4:1 | |||||||
| Neutropenic infection | G5:1 | |||||||
| Anaemia | G3:1 | G2:1 | ||||||
| G1:1 | ||||||||
| Thrombocytopenia | G3:1 | |||||||
| G1:1 | ||||||||
| Fatigue | G2:1 | G1:4 | G1:3 | |||||
| Headache | G1:1 | G1:1 | ||||||
| Diarrhoea | G1:1 | G1:1 | ||||||
| Nausea | G1:1 | G1:1 | G1:1 | G1:1 | ||||
| Vomiting | G1:1 | |||||||
| Alopecia | G1:2 | |||||||
| Rhinitis | G1:1 | |||||||
| Cough | G1:1 | |||||||
| Myalgia | G1:1 | |||||||
| Arthralgia | G1:1 | |||||||
| Syncope | G3:1 | |||||||
NOTE: Number of worst grade adverse events possibly, probably, or definitely attributed to BPU during study drug administration. Toxicities are graded per the NCI CTC version 2 criteria. “G1:2” denotes 2 patients had grade 1 toxicity. Dose-limiting toxicities are indicated in bold.
a
This subject was the only patient dose-escalated; after receiving five cycles (cycle 1-5) at 20 mg and three cycles (cycles 6-8) at 40 mg, the patient was returned to 20 mg (cycles 9-15) due to grade 3 syncope during cycle 8. No further syncopal events occurred after the subject's antihypertensive medication was discontinued