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NCT Number: NCT03333005

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

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

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Cologne, Center for Integrated Oncology (CIO), Cologne, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APX001 with Standard of Care anti-fungal agent

Drug

safety assessment

Primary outcomes

  1. 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

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: One to forty-four days

  2. Peak Plasma Concentration (Cmax)

    Time frame: One to forty-four days

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Collaborators

  • The Clinical Trials Centre Cologne

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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