A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Purpose
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.
Condition
- Invasive Mold Infections
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- An open-label, 2-cohort study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort A: Experimental Treatment |
Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form. |
|
|
Active Comparator Cohort A: Comparator Antifungal Treatment |
Best available therapy (BAT) administered as IV or orally per standard guidelines. |
|
|
Experimental Cohort B |
Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35294-0006
More Details
- Status
- Recruiting
- Sponsor
- Basilea Pharmaceutica