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Study on Safety and Pharmacokinetics of Intravenous F901318 for Fungal Prophylaxis in AML Patients

NCT02856178 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-02-15

No results posted yet for this study

Summary

This study assesses the pharmacokinetics and safety of the new antifungal F901318 in AML patients.

Conditions

Interventions

DRUG

F901318

F901318 treatment starting after completion of chemotherapy. Max. 14 days of intravenous F901318 b.i.d. treatment, followed by one oral dose of F901318. Loading doses 4 mg/kg b.i.d. , maintenance doses 2 mg/kg b.i.d.

DRUG

Caspofungin

Intravenous Caspofungin treatment starting during chemotherapy for concomitant prophylaxis of fungal infection. Loading dose 70 mg q.d., maintenance doses 50 mg q.d.

Sponsors & Collaborators

  • University Hospital of Cologne

    collaborator OTHER

  • F2G Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Oliver Cornely, PhD, MD · University Hospital Cologne

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2017-04-20
Completion
2017-04-20

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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 NCT02856178 on ClinicalTrials.gov