Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05101187
Ethics application status
Date submitted
7/09/2021
Date registered
1/11/2021
Date last updated
27/09/2024

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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Belgium
State/province [20] 0 0
Brugge
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Brazil
State/province [24] 0 0
Minas Gerais
Country [25] 0 0
Brazil
State/province [25] 0 0
Paraná
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio Grande Do Sul
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
China
State/province [29] 0 0
Anhui
Country [30] 0 0
China
State/province [30] 0 0
Hubei
Country [31] 0 0
China
State/province [31] 0 0
Jiangxi
Country [32] 0 0
China
State/province [32] 0 0
Shandong
Country [33] 0 0
China
State/province [33] 0 0
Shanghai
Country [34] 0 0
China
State/province [34] 0 0
Tianjin
Country [35] 0 0
China
State/province [35] 0 0
Zhejiang
Country [36] 0 0
China
State/province [36] 0 0
Beijing
Country [37] 0 0
China
State/province [37] 0 0
Changchun
Country [38] 0 0
China
State/province [38] 0 0
Changsha
Country [39] 0 0
China
State/province [39] 0 0
Chenzhou
Country [40] 0 0
China
State/province [40] 0 0
Fuzhou
Country [41] 0 0
China
State/province [41] 0 0
Guangzhou
Country [42] 0 0
China
State/province [42] 0 0
Hangzhou
Country [43] 0 0
China
State/province [43] 0 0
Hefei
Country [44] 0 0
China
State/province [44] 0 0
Nanning
Country [45] 0 0
China
State/province [45] 0 0
Shengyang
Country [46] 0 0
China
State/province [46] 0 0
Shijiazhuang
Country [47] 0 0
China
State/province [47] 0 0
Xi'an
Country [48] 0 0
China
State/province [48] 0 0
Zhengzhou
Country [49] 0 0
France
State/province [49] 0 0
Bas Rhin
Country [50] 0 0
France
State/province [50] 0 0
Doubs
Country [51] 0 0
France
State/province [51] 0 0
Gironde
Country [52] 0 0
France
State/province [52] 0 0
Haute Garonne
Country [53] 0 0
France
State/province [53] 0 0
Ille-et-Vilaine
Country [54] 0 0
France
State/province [54] 0 0
Loire Atlantique
Country [55] 0 0
France
State/province [55] 0 0
Nord
Country [56] 0 0
France
State/province [56] 0 0
Paris
Country [57] 0 0
Germany
State/province [57] 0 0
Saxony
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Hamburg-Eppendorf
Country [60] 0 0
Germany
State/province [60] 0 0
Koeln
Country [61] 0 0
Israel
State/province [61] 0 0
Beer-Sheva
Country [62] 0 0
Israel
State/province [62] 0 0
Jerusalem
Country [63] 0 0
Israel
State/province [63] 0 0
Ramat Gan
Country [64] 0 0
Israel
State/province [64] 0 0
Tel Aviv
Country [65] 0 0
Italy
State/province [65] 0 0
Campania
Country [66] 0 0
Italy
State/province [66] 0 0
Di Monza E Della Brianza
Country [67] 0 0
Italy
State/province [67] 0 0
Milano
Country [68] 0 0
Italy
State/province [68] 0 0
Genova
Country [69] 0 0
Italy
State/province [69] 0 0
Modena
Country [70] 0 0
Italy
State/province [70] 0 0
Perugia
Country [71] 0 0
Italy
State/province [71] 0 0
Pisa
Country [72] 0 0
Italy
State/province [72] 0 0
Roma
Country [73] 0 0
Japan
State/province [73] 0 0
Chiba Ken
Country [74] 0 0
Japan
State/province [74] 0 0
Fukuoka Ken
Country [75] 0 0
Japan
State/province [75] 0 0
Miyagi Ken
Country [76] 0 0
Japan
State/province [76] 0 0
Osaka Fu
Country [77] 0 0
Japan
State/province [77] 0 0
Tokyo To
Country [78] 0 0
Japan
State/province [78] 0 0
Tokyo
Country [79] 0 0
Japan
State/province [79] 0 0
Bunkyo-Ku
Country [80] 0 0
Japan
State/province [80] 0 0
Nagasaki
Country [81] 0 0
Japan
State/province [81] 0 0
Okayama
Country [82] 0 0
Japan
State/province [82] 0 0
Saitama
Country [83] 0 0
Japan
State/province [83] 0 0
Shimotsuke
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Seoul
Country [85] 0 0
Netherlands
State/province [85] 0 0
Nijmegen
Country [86] 0 0
Netherlands
State/province [86] 0 0
Utrecht
Country [87] 0 0
New Zealand
State/province [87] 0 0
Wellington
Country [88] 0 0
New Zealand
State/province [88] 0 0
Auckland
Country [89] 0 0
Singapore
State/province [89] 0 0
Singapore
Country [90] 0 0
Spain
State/province [90] 0 0
Madrid
Country [91] 0 0
Spain
State/province [91] 0 0
Barcelona
Country [92] 0 0
Spain
State/province [92] 0 0
Valencia
Country [93] 0 0
Taiwan
State/province [93] 0 0
Kaohsiung
Country [94] 0 0
Taiwan
State/province [94] 0 0
New Taipei City
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taichung
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taipei
Country [97] 0 0
Thailand
State/province [97] 0 0
Bangkok
Country [98] 0 0
Thailand
State/province [98] 0 0
Khon Kaen
Country [99] 0 0
Turkey
State/province [99] 0 0
Ankara
Country [100] 0 0
Turkey
State/province [100] 0 0
Diyarbakir
Country [101] 0 0
Turkey
State/province [101] 0 0
Istanbul
Country [102] 0 0
Turkey
State/province [102] 0 0
Izmir
Country [103] 0 0
Turkey
State/province [103] 0 0
Samsun
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Wales
Country [105] 0 0
United Kingdom
State/province [105] 0 0
London

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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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