Table 2. Dose levels, dose limiting toxicities and AZD0424-related AE episodes.
| Cohort | AZD0424 dose mg | Patients treated | Total cycles AZD0424 started | Patients evaluable | Patients experiencing DLT | Description of DLT | Related AE episodes per patient (mean (range)) | Related Grade 3–5 AE episodes per patient (mean (range)) |
|---|---|---|---|---|---|---|---|---|
| 1 | 5 mg o.d. | 1 | 2 | 1 | 0 | 2.0 (2 to 2) | 0 | |
| 2 | 10 mg o.d. | 1 | 7 | 1 | 0 | 5.0 (5 to 5) | 0 | |
| 3 | 20 mg o.d. | 4 | 9 | 3 | 0 | 7.33 (6 to 9) | 0 | |
| 4 | 40 mg o.d. | 4 | 13 | 3 | 0 | 4.50 (1 to 7) | 1.0 (1 to 1) | |
| 5 | 60 mg o.d. | 3 | 5 | 3 | 0 | 4.0 (4 to 4) | 1.0 (1 to 1) | |
| 6 | 80 mg o.d. | 3 | 5 | 3 | 0 | 9.50 (5 to 14) | 0 | |
| 7 | 120 mg o.d. | 11 | 19 | 7 | 1 | G3 diarrhoea and melaena | 8.90 (3 to 19) | 2.50 (1 to 4) |
| 8 | 150 mg o.d. | 7 | 11 | 5 | 2 | G3 maculopapular rash G3 fatigue, anorexia and maculopapular rash | 10.14 (1 to 22) | 3.0 (1 to 8) |
| 9 | 40 mg b.d. | 7 | 11 | 6 | 2 | G3 fatigue Completed <75% of Cycle 1 doses due to combination G2 nausea, fatigue, and anorexia | 12.29 (5 to 17) | 2.75 (2 to 4) |
Abbreviations: AE=adverse event; b.d.=bi-daily; DLT=dose-limiting toxicity; o.d.=once-daily.