Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia
NCT ID: NCT03333005
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2017-11-27
2018-10-26
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
OTHER
NONE
Study Groups
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APX001 with Standard of Care Anti-fungal agent
APX001 with Standard of Care anti-fungal agent
safety assessment
Interventions
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APX001 with Standard of Care anti-fungal agent
safety assessment
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Current fever (\> 38 degrees Celsius)
* Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine
18 Years
75 Years
ALL
No
Sponsors
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The Clinical Trials Centre Cologne
OTHER
Basilea Pharmaceutica
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Engelhardt
Role: STUDY_DIRECTOR
Basilea Pharmaceutica International Ltd, Allschwil
Locations
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University of Cologne, Center for Integrated Oncology (CIO)
Cologne, , Germany
Johannes Gutenberg, University of Mainz
Mainz, , Germany
University of Munich, Grosshadern Campus
Munich, , Germany
Countries
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Other Identifiers
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APX001-103
Identifier Type: -
Identifier Source: org_study_id
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