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

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ClinicalTrials.gov Identifier: NCT03333005
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
The Clinical Trials Centre Cologne
Information provided by (Responsible Party):
Amplyx Pharmaceuticals

Brief 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


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: APX001 with Standard of Care anti-fungal agent Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Sequential Assignment
Intervention Model Description: The first 10 patients enrolled will be administered IV APX001. The second 10 patients enrolled will be administered oral APX001
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : October 26, 2018


Arm Intervention/treatment
Experimental: APX001 with Standard of Care Anti-fungal agent Drug: APX001 with Standard of Care anti-fungal agent
safety assessment




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333005


Locations
Germany
University of Cologne, Center for Integrated Oncology (CIO)
Cologne, Germany, 50931
Johannes Gutenberg, University of Mainz
Mainz, Germany, 55131
University of Munich, Grosshadern Campus
Munich, Germany, 81377
Sponsors and Collaborators
Amplyx Pharmaceuticals
The Clinical Trials Centre Cologne
Investigators
Principal Investigator: Oliver A Cornely, MD University of Cologne, Center for Integrated Oncology

Responsible Party: Amplyx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03333005     History of Changes
Other Study ID Numbers: APX001-103
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neutropenia
Neoplasms by Histologic Type
Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Antifungal Agents
Miconazole
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors