Table 2 Dose-limiting toxicities per dose level
Dose level | |||||||
|---|---|---|---|---|---|---|---|
1 | 2 | 3 | Total | ||||
Number of patients | 4 (100%) | 13 (100%) | 7 (100%) | 24 (100%) | |||
Any DLTs? | |||||||
No | 3 (75%) | 12 (92%) | 2 (29%) | 17 (71%) | |||
Yes | 1 (25%) | 1 (8%) | 5 (71%) | 7 (29%) | |||
If yes: | |||||||
CTC-Grade | III | IV | III | IV | III | IV | |
Non-haematological toxicity grade ≥ 3: | 6 (25%) | ||||||
- Dehydration, syncope | 1 | ||||||
- Heartburn/dyspepsia | 1 | ||||||
- Fatigue | 2 | ||||||
- Diarrhea | 1 | ||||||
- Infection | 1 | ||||||
Haematological toxicity: | 1 (4%) | ||||||
- Thrombocytpenia | 1 | ||||||