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Olorofim Aspergillus Infection Study (OASIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 7, 2021
First Posted Date  ICMJE November 1, 2021
Last Update Posted Date June 1, 2023
Actual Study Start Date  ICMJE March 31, 2022
Estimated Primary Completion Date September 14, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2021)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2021)
  • 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).
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olorofim Aspergillus Infection Study
Official Title  ICMJE 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
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
Adjudicator and sponsor-blinded.
Primary Purpose: Treatment
Condition  ICMJE Invasive Aspergillosis
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • Active Comparator: Olorofim
    Olorofim versus AmBisome followed by Standard of Care (SOC)
    Intervention: Drug: Olorofim
  • Active Comparator: AmBisome
    Olorofim versus AmBisome followed by Standard of Care (SOC)
    Intervention: Drug: AmBisome®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2021)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 4, 2025
Estimated Primary Completion Date September 14, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniela Zinzi, MD +43 06643582281 DZinzi@f2g.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   France,   Israel,   Netherlands,   Singapore,   Spain,   Taiwan,   Thailand,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05101187
Other Study ID Numbers  ICMJE F901318/0041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party F2G Biotech GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE F2G Biotech GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Iqvia Pty Ltd
Investigators  ICMJE
Principal Investigator: Johan Maertens, MD UZ Leuven
PRS Account F2G Biotech GmbH
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP