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Safety and Pharmacokinetics of Oral F901318 (Fluconazole and Posaconazole) IN Aml Leukaemia

NCT03036046 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-02-15

No results posted yet for this study

Summary

Non-randomized, multi-centre, open label, uncontrolled, multiple dose, phase IIa study.

A total of 18 patients diagnosed with acute myeloid leukaemia (AML) scheduled for chemotherapy and expected to be neutropenic (\<500 Absolute neutrophil count (ANC)/µl) for \>10 days will be treated. F901318 will be given in conjunction with fluconazole or posaconzaole in order to assess safe treatment regimens for both combinations.

Conditions

Interventions

DRUG

F901318 with fluconazole low dose

adverse events

DRUG

F901318 with fluconazole high dose

adverse events

DRUG

F901318 with posaconazole

adverse events

Sponsors & Collaborators

  • The Clinical Trials Centre Cologne

    collaborator OTHER

  • Klinik für Hämatologie, Aachen

    collaborator UNKNOWN

  • Medizinische Klinik Würzburg

    collaborator UNKNOWN

  • F2G Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Oliver A Cornely, MD · University Hospital Cologne

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2017-09-30
Completion
2018-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03036046 on ClinicalTrials.gov