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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05101187




Registration number
NCT05101187
Ethics application status
Date submitted
7/09/2021
Date registered
1/11/2021
Date last updated
4/06/2024

Titles & IDs
Public title
Olorofim Aspergillus Infection Study
Scientific 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
Secondary ID [1] 0 0
F901318/0041
Universal Trial Number (UTN)
Trial acronym
OASIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Aspergillosis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Olorofim
Treatment: Drugs - AmBisome®

Active Comparator: Olorofim - Olorofim versus AmBisome followed by Standard of Care (SOC)

Active Comparator: AmBisome - Olorofim versus AmBisome followed by Standard of Care (SOC)


Treatment: Drugs: 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)

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
Treatment Day 42
Secondary outcome [1] 0 0
Adjudicated Assessment of Overall outcome
Timepoint [1] 0 0
Day 42, Day 84, and End of Treatment (anytime during the study between first administration and Day 84)
Secondary outcome [2] 0 0
Investigator-assessed overall response
Timepoint [2] 0 0
Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]), and 4-week Follow-up (FU).
Secondary outcome [3] 0 0
To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Galactomannan index.
Timepoint [3] 0 0
Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]) and 4-week Follow-up (FU)
Secondary outcome [4] 0 0
To collect additional olorofim and the disproportionate metabolite H26C pharmacokinetic (PK) data for inclusion in a Population PK model
Timepoint [4] 0 0
Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 70, Day 84, and at EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])
Secondary outcome [5] 0 0
Data Review Committee's Assessment of Patient Mortality
Timepoint [5] 0 0
Day 42 and 84 and EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])
Secondary outcome [6] 0 0
Diagnosis of a secondary fungal infection
Timepoint [6] 0 0
at any time through End Of Treatment
Secondary outcome [7] 0 0
Quality of life as measured by the 5 Level 5 Dimension (EQ-5D-5L) at Baseline
Timepoint [7] 0 0
Days 14 and EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])
Secondary outcome [8] 0 0
Survival status
Timepoint [8] 0 0
Day 42, Day 84, and End Of Treatment and at the 4 weeks ± 7 days FU
Secondary outcome [9] 0 0
Safety Assessment
Timepoint [9] 0 0
up to the Day 84 and 4-week Follow-up (FU)

Eligibility
Key inclusion criteria
1. Male and female patients ages over 18 years and weighing more than 30 kg

2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as
adapted for this study and where the duration of specific therapy for this episode of
IA has been = 28 days. For purposes of this inclusion, the duration of specific
therapy includes any mould-active therapy given for this episode of IA whether
subsequently judged potentially effective or not.

3. Patients requiring therapy with an antifungal agent other than a mould-active azole,
and who have had = 96 hours of potentially effective prior therapy. Potentially
effective prior therapy includes any agent to which the infecting strain of
Aspergillus is likely to be susceptible. There are no exclusions or limitations on
such agents (eg, AmBisome® is permitted) other than their duration.

4. AmBisome® is an appropriate therapy for the patient.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 requirement for ongoing use of 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal NorthShore Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3181 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
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Missouri
Country [8] 0 0
United States of America
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Nevada
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Brazil
State/province [17] 0 0
Belgium
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Brazil
State/province [18] 0 0
Minas Gerais
Country [19] 0 0
Brazil
State/province [19] 0 0
Paraná
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio Grande Do Sul
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
China
State/province [23] 0 0
Anhui
Country [24] 0 0
China
State/province [24] 0 0
Hubei
Country [25] 0 0
China
State/province [25] 0 0
Jiangxi
Country [26] 0 0
China
State/province [26] 0 0
Shandong
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
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China
State/province [28] 0 0
Tianjin
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China
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Zhejiang
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France
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Bas Rhin
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France
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Doubs
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France
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Gironde
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France
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Ille-et-Vilaine
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France
State/province [34] 0 0
Loire Atlantique
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France
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Nord
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France
State/province [36] 0 0
Paris
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Germany
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Saxony
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Germany
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Berlin
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Germany
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Koeln
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Israel
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Beer-Sheva
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Campania
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Italy
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Genova
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Italy
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Milano
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Italy
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Modena
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Roma
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Japan
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Chiba Ken
Country [52] 0 0
Japan
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Fukuoka Ken
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Japan
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Miyagi Ken
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Japan
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Osaka Fu
Country [55] 0 0
Japan
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Tokyo To
Country [56] 0 0
Japan
State/province [56] 0 0
Tokyo
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Japan
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Nagasaki
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Japan
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Okayama
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Korea, Republic of
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Seoul
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Netherlands
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Nijmegen
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Netherlands
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Utrecht
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New Zealand
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Wellington
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New Zealand
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Auckland
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Singapore
State/province [64] 0 0
Singapore
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Spain
State/province [65] 0 0
Madrid
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Spain
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Barcelona
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Spain
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Valencia
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Taiwan
State/province [68] 0 0
Kaohsiung
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Taiwan
State/province [69] 0 0
New Taipei City
Country [70] 0 0
Taiwan
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Taipei
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Thailand
State/province [71] 0 0
Bangkok
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Thailand
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Khon Kaen
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Turkey
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Ankara
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Turkey
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Diyarbakir
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Turkey
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Istanbul
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Turkey
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Izmir
Country [77] 0 0
Turkey
State/province [77] 0 0
Samsun
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
F2G Biotech GmbH
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Shionogi
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05101187
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johan Maertens, MD
Address 0 0
UZ Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daniela Zinzi, MD
Address 0 0
Country 0 0
Phone 0 0
+43 06643582281
Fax 0 0
Email 0 0
DZinzi@f2g.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05101187