A study to evaluate the efficacy and safety of olorofim versus AmBisome® for treatment of invasive aspergillosis.

Phase 1

• Conditions: invasive fungal infections due to Aspergillus spp.; MedDRA version: 20.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-000386-32-NL
• Lead Sponsor: F2G Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-29
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

1) Male and female patients ages =18 years and weighing more than 40 kg
2) Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study
3) Patients requiring therapy with an antifungal agent other than a mould-active azole on the basis of IA refractory to mould-active azole therapy, proven resistance to the mould active azoles, breakthrough infection on mould-active triazole prophylaxis, or azole drug-drug interactions (or potential for drug-drug interactions).
4) AmBisome® is an appropriate therapy for the patient.
5) Ability and willingness to comply with the protocol.
6) Female patients must be non-lactating and at no risk of pregnancy.
7) Male patients with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception
8) Patients must be able to take oral medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 169
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

1) Women who are pregnant or breastfeeding.
2) Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
3) Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
4) Suspected mucormycosis (zygomycosis).
5) Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole.
6) The use of an echinocandin as Candida prophylaxis.
7) Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features.
8) Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy.
9) Patients with a baseline prolongation of QT using Fridericia’s Correction Formula (QTcF) = 500 msec, or at high risk for QT/QTc prolongation.
10) Evidence of hepatic dysfunction.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified