Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia
Status:
Completed
Trial end date:
2018-10-26
Target enrollment:
Participant gender:
Summary
An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of
intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia
with neutropenia.
A total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous
drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing.
All patients will receive chemotherapy for their AML according to local clinical standard of
care as well as antifungal prophylaxis.
APX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of
chemotherapy