A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.

a study on Invasive Mold Infections

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

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.

Official Title

An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds

Keywords

Invasive Mold Infections, Fungal infection, Antifungal, Mold infection, Rare molds, Multidrug resistant mold, Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, Scedosporium spp., Mycoses, Fosmanogepix IV infusion, Fosmanogepix oral tablet

Eligibility

For people ages 18 years and up

Main Inclusion Criteria:

  1. Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds.
  2. Patient's condition allows for appropriate infection source control measures.

Main Exclusion Critera:

  1. Refractory hematologic malignancy.
  2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  3. COVID-19 associated mucormycosis.
  4. Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.
  5. Patients with a Karnofsky Performance Status < 20 at Screening.
  6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
  7. Patients with known human immunodeficiency virus infection.
  8. Ongoing neurological disorders.
  9. Patients receiving hospice/comfort care only.
  10. Other medical or psychiatric condition.
  11. Current use of any prohibited concomitant medication(s).
  12. Current/ previous administration of an investigational drug within 30 days.
  13. Prior enrollment in this or any previous study of fosmanogepix.
  14. Moderate or severe hepatic impairment.
  15. Patient who is pregnant or lactating.
  16. Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.

Locations

  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095-1690 United States
  • The University of Texas Health Science Center at Houston, Department of Internal Medicine accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Basilea Pharmaceutica
ID
NCT06925321
Phase
Phase 3 Invasive Mold Infections Research Study
Study Type
Interventional
Participants
Expecting 219 study participants
Last Updated
Contact us about this trial