The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period. The patient will be assigned to one of two treatment cohorts: Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment. Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
219
Fosmanogepix will be administered IV
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
Fosmanogepix will be administered orally.
University of Alabama at Birmingham School of Medicine, Department of Medicine
Birmingham, Alabama, United States
RECRUITINGDavid Geffen School of Medicine at UCLA
Los Angeles, California, United States
RECRUITINGKarmanos Cancer Institute - Detroit
Detroit, Michigan, United States
RECRUITINGUniversity of Minnesota, M Health Fairview Medical Center
Minneapolis, Minnesota, United States
RECRUITINGWashington University School of Medicine, Infectious Diseases Clinical Research Unit
St Louis, Missouri, United States
RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGDuke University Medical Center, Duke Infectious Diseases
Durham, North Carolina, United States
RECRUITINGThe University of Texas Health Science Center at Houston, Department of Internal Medicine
Houston, Texas, United States
RECRUITINGPrincess Alexandra Hospital
Woolloongabba, Australia
RECRUITINGKepler University Hospital GmbH, Department of Internal Medicine IV - Pulmonology
Linz, Austria
RECRUITING...and 8 more locations
Day 42 all-cause mortality rate
Time frame: Day 42
Proportion of patients with overall response of treatment success
Time frame: Day 42, Day 84 and up to 180 days
Proportion of patients with clinical response of treatment success
Time frame: Day 42, Day 84 and up to 180 days
Proportion of patients with mycological response of eradication or presumed eradication
Time frame: Day 42, Day 84 and up to 180 days
Proportion of patients with radiological response of complete response or partial response
Time frame: Day 42, Day 84 and up to 180 days
All-cause mortality rate at Day 84
Time frame: Day 84
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related AEs, adverse events of special interest (AESI), and AEs leading to discontinuation
Time frame: Screening up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Number of patients with clinically significant laboratory abnormalities
Time frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Number of patients with abnormal neurological examination findings
Time frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Assessment of 12-lead electrocardiogram corrected QT (Fridericia method) Interval (ECG QTcF Interval)
Time frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following IV administration
Time frame: Pre-dose, 3,6, and 9 hours post-start of the 3-hour IV infusion on Day 3, and at 24 hours (prior to Day 4 dosing)
Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following oral administration
Time frame: On days 7, 14, 28, and 42. Post-dose plasma samples will also be collected: 72 hrs and 192 hrs after last dose.
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