An Open Label, Multi-Center Study to Determine the Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia With Neutropenia

APX001-103

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

2017-11-27

2018-10-26

2018-10-26

Completed

Early phase I

20

Key Inclusion Criteria: * Provision of written consent * Ages 18-75 inclusive, male or female * Diagnosis of Acute Myeloid Leukemia * Patients entering first induction treatment chemotherapy * Expected to be neutropenic (\<500 ANC/ul) for \>/= 10 days Key Exclusion Criteria: * Patients who received systemic antifungal therapy for proven or probable fungal infections within the last 12 months * Current fever (\> 38 degrees Celsius) * Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The first 10 patients enrolled will be administered IV APX001. The second 10 patients enrolled will be administered oral APX001', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2024-05-17