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An Open Label Phase IIa Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral F901318 (Combined With Fluconazole and Posaconazole) in AML (SAFEGUARDFP)
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.
Details
| Lead sponsor | F2G Ltd |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | WITHDRAWN |
| Start date | 2017-03 |
| Completion | 2018-03 |
Conditions
- Acute Myeloid Leukemia
Interventions
- F901318 with fluconazole low dose
- F901318 with fluconazole high dose
- F901318 with posaconazole
Primary outcomes
- Safety (adverse events) — 63 days
Adverse events