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

Basilea Pharmaceutica20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Cologne, Center for Integrated Oncology (CIO)

Cologne, Germany

Johannes Gutenberg, University of Mainz

Mainz, Germany

University of Munich, Grosshadern Campus

Munich, Germany

Outcomes

Primary Outcomes

Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0

Time frame: One to forty-four days

Secondary Outcomes

Area under the plasma concentration versus time curve (AUC)

Time frame: One to forty-four days

Peak Plasma Concentration (Cmax)

Time frame: One to forty-four days