Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT03333005
Brief 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
Study:
NCT03333005
Study Brief:
Protocol Section:
NCT03333005