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

ConditionInvasive Mold Infections
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBasilea Pharmaceutica

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Patient's condition allows for appropriate infection source control measures.

Refractory hematologic malignancy.

Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fosmanogepix IV infusion

    Drug

    Fosmanogepix will be administered IV

  • Standard of care antifungal therapy

    Drug

    Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines

  • Fosmanogepix oral tablet

    Drug

    Fosmanogepix will be administered orally.

Treatment groups

234 Participants
are divided into 3 treatment groups
Group A: Cohort A: Experimental TreatmentExperimental treatment 2 interventions
Group B: Cohort A: Comparator Antifungal TreatmentActive comparator 1 intervention
Group C: Cohort BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Day 42 all-cause mortality rate

Time frame
Day 42

Secondary outcomes

1

Proportion of patients with overall response of treatment success

Time frame
Day 42, Day 84 and up to 180 days
2

Proportion of patients with clinical response of treatment success

Time frame
Day 42, Day 84 and up to 180 days
3

Proportion of patients with mycological response of eradication or presumed eradication

Time frame
Day 42, Day 84 and up to 180 days
4

Proportion of patients with radiological response of complete response or partial response

Time frame
Day 42, Day 84 and up to 180 days

Other outcomes

Sponsors and contacts

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Basilea Pharmaceutica

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator

Source ClinicalTrials.gov
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