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

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

April 20, 2017

Primary Completion Date

April 20, 2017

Study Completion Date

April 20, 2017

Conditions
Pulmonary Aspergillosis - InvasiveAcute Myeloid Leukemia
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

Lead Sponsor

All Listed Sponsors
collaborator

University Hospital of Cologne

OTHER

lead

F2G Biotech GmbH

INDUSTRY