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DEFEAT Mucor: Deferasirox for Mucormycosis
NCT00419770Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2007
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- The Lundquist Institute
- Modality
- Small Molecules
- Drugs
- deferasirox
- Conditions
- mucormycosis
01
Overview
Phase 2, randomised, double-blind trial in mucormycosis comparing Deferasirox + LAmB with Placebo + LAmB (2 arms). Primary endpoints: Safety and Tolerability of Adjunctive Deferasirox Therapy at 14 days, Global Response Rate (Composite of Clinical and Radiographic Response) at 14 days and 1 more. Started Oct 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Deferasirox + LAmB
Deferasirox (20 mg/kg/day) + Liposomal Amphotericin B
Placebo + LAmB
Placebo + Liposomal Amphotericin B
03
Who it enrols
Patients >2 years old with proven or probable invasive mucormycosis, radiographic evidence of infection, and <14 days of prior polyene therapy. Excludes patients with significant renal or hepatic dysfunction, or high likelihood of death within 48h.
04
Endpoints
Primary
Safety and Tolerability of Adjunctive Deferasirox Therapy
Global Response Rate (Composite of Clinical and Radiographic Response)
Total Adverse Events
Secondary
Deferasirox Pharmacokinetic and Pharmacodynamic Parameters
Survival, Radiographic Improvement, Clinical Response, Time to Survival, Deferasirox vs. Free Iron Level Correlation
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