Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia

Basilea Pharmaceutica

Status and phase

Completed

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: APX001 with Standard of Care anti-fungal agent

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03333005

APX001-103

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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