Pacitinib dose cohort | Patients, n | DLTs in first cycle | ||
---|---|---|---|---|
N (%) | Description | Outcome | ||
100Â mg | 3 | 0 | Â | Â |
150 mg | 6 | 1 (16.7) | Grade 3 ECG QT prolonged from days 18–47 | Resolved following pacritinib discontinuation. |
200Â mg | 9a | 0 | Â | Â |
300 mg | 6 | 1 (16.7) | Grade 3 diarrhea on days 3–4. | Resolved following interruption of pacritinib and treatment with antidiarrheal medication. Pacritinib was restarted. |
400Â mg | 6 | 0 | Â | Â |
500 mg | 7 | 1 (14.3) | Grade 2 diarrhea on days 8–140. | Resolved following dose reduction to 400 mg and treatment with antidiarrheal medication. |
600Â mg | 6 | 2 (33.3) | Grade 3 diarrhea beginning on day 11. | Pacritinib was interrupted then reduced to 400Â mg. Antidiarrheal medication was started. Diarrhea was ongoing at the end of treatment. |
Grade 1 nausea; grade 1 vomiting; grade 2 dizziness, grade 2 gait disturbance, grade 2 performance status decreased, grade 2 vision blurred | Pacritinib was interrupted then reduced to 400Â mg. Nausea and vomiting resolved with antiemetic therapy after ~85Â days; dizziness resolved after 49Â days; performance status decrease resolved after 4Â days. Gait disturbance and vision blurred were ongoing at the end of treatment. |