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Olorofim Aspergillus Infection Study (OASIS)

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ClinicalTrials.gov Identifier: NCT05101187
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : June 1, 2023
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
F2G Biotech GmbH

Brief Summary:
The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Drug: Olorofim Drug: AmBisome® Phase 3

Detailed Description:

The mortality rate in immunosuppressed patients with IA is high even with effective modern antifungal drug treatment. Intrinsic and acquired resistance to azoles and amphotericin B, the two most effective classes of treatment, have been identified in Aspergillus species and are linked to this increased mortality.

Currently marketed antifungal drugs have limitations including limited dosage forms, DDIs, and significant adverse reactions.

For patients with IA who do not respond to or cannot tolerate a triazole therapy, treatment options are even more limited.

Olorofim is an antifungal candidate with a novel mechanism of action offering activity against resistant organisms, differences in safety profile, along with oral dosing, predictable and reliable pharmacokinetic (PK) profile and limited potential for DDIs.

The present study is designed to compare the efficacy, safety, and tolerability of olorofim with that of AmBisome® followed by guideline-based hierarchy standard of care (SOC) in patients with IA whose infection is either refractory to or unsuitable for azole therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Adjudicator and sponsor-blinded.
Primary Purpose: Treatment
Official Title: Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus Species
Actual Study Start Date : March 31, 2022
Estimated Primary Completion Date : September 14, 2024
Estimated Study Completion Date : March 4, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Active Comparator: Olorofim
Olorofim versus AmBisome followed by Standard of Care (SOC)
Drug: Olorofim
Loading Dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 Maintenance Dose: 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 84 (± 7 days)
Other Name: Olorofim (F901318)

Active Comparator: AmBisome
Olorofim versus AmBisome followed by Standard of Care (SOC)
Drug: AmBisome®
Initial course of at least 10 days of AmBisome® administered daily at a dose of 3 mg/kg by IV infusion over a 30- to 60-minute period or according to local guidelines Administration of SOC will follow international, national, or local guidelines and product labelling.
Other Name: AmBisome® (liposomal amphotericin B)




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Treatment Day 42 ]
    To compare all-cause mortality (ACM) at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in the intent-to-treat (ITT) population of patients with Invasive Fungal Disease (IFD) caused by proven Invasive Aspergillosis (IA) or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).


Secondary Outcome Measures :
  1. Adjudicated Assessment of Overall outcome [ Time Frame: Day 42, Day 84, and End of Treatment (anytime during the study between first administration and Day 84) ]
    To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Data Review Committee (DRC)-adjudicated assessment of overall outcome in patients with proven IA or probable LRTD IA at Day 42, Day 84, and End of Treatment (anytime during the study between first administration and Day 84).

  2. Investigator-assessed overall response [ Time Frame: Day 14, Day 28, Day 42, Day 84, End of Treatment (anytime during the study between first administration and Day 84) and 4-week Follow-up (FU) ]
    To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Investigator integrated assessessment of clinical signs and symptoms, radiological response and mycological response related to the IFD caused by Aspergillus species.

  3. Safety Assessment [ Time Frame: up to the Day 84 and 4-week Follow-up (FU) ]
    To monitor incidence of Adverse Events and Serious Adverse Events in both treatment arms (Olorofim or AmBisome followed by Standard of Care).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients ages over 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05101187


Contacts
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Contact: Daniela Zinzi, MD +43 06643582281 DZinzi@f2g.com

Locations
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Sponsors and Collaborators
F2G Biotech GmbH
Iqvia Pty Ltd
Investigators
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Principal Investigator: Johan Maertens, MD UZ Leuven
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Responsible Party: F2G Biotech GmbH
ClinicalTrials.gov Identifier: NCT05101187    
Other Study ID Numbers: F901318/0041
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by F2G Biotech GmbH:
Invasive fungal disease (IFD)
Aspergillus species
Olorofim
Non-azole antifungal
Azole resistance
Additional relevant MeSH terms:
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Aspergillosis
Mycoses
Bacterial Infections and Mycoses
Infections
Amphotericin B
Liposomal amphotericin B
Olorofim
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents