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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333005
• Other study ID #: APX001-103
• Status: Completed
• Phase: Phase 1
• Start date: November 27, 2017
• Est. completion date: October 26, 2018

Study information

• Verified date: May 2024
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Neutropenia

Intervention

Drug:
• APX001 with Standard of Care anti-fungal agent
safety assessment

Locations

Country	Name	City	State
Germany	University of Cologne, Center for Integrated Oncology (CIO)	Cologne
Germany	Johannes Gutenberg, University of Mainz	Mainz
Germany	University of Munich, Grosshadern Campus	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Basilea Pharmaceutica	The Clinical Trials Centre Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0		One to forty-four days
Secondary	Area under the plasma concentration versus time curve (AUC)		One to forty-four days
Secondary	Peak Plasma Concentration (Cmax)		One to forty-four days