drugset / Trial / NCT03036046
Safety and Pharmacokinetics of Oral F901318 (Fluconazole and Posaconazole) IN Aml Leukaemia
Phase 1/2
Withdrawn
F2G Ltd
Klinik für Hämatologie, Aachen · collabThe Clinical Trials Centre Cologne · collabWuerzburg University Hospital · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2017-03
- Primary completion
- 2017-09
- Completion
- 2018-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluconazole | Small molecule | — | — |
| Subject | Olorofim | Small molecule | — | Oral |
| Subject | Posaconazole | Small molecule | — | — |