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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03583164




Registration number
NCT03583164
Ethics application status
Date submitted
17/05/2018
Date registered
11/07/2018

Titles & IDs
Public title
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
Scientific title
Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options
Secondary ID [1] 0 0
F901318/0032
Universal Trial Number (UTN)
Trial acronym
FORMULA-OLS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Fungal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

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

Experimental: Olorofim (F901318) - Olorofim (F901318) was given orally for up to 90 days in the Main Study Phase and could be continued for those participants entering the Extended Treatment Phase.

Patients received fixed doses comprising of a 1-day loading dose of 150 mg of olorofim twice a day followed by a maintenance dose of 90 mg of olorofim twice a day.

Up until Protocol Amendment 06, 58 patients received a weight-based olorofim dosing consisting of a 1-day loading dose of 4 mg/kg/day on Day 1, then a maintenance dose of 2.5 mg/kg/day (divided into 2 or 3 doses). The dose was then adjusted based on plasma levels of olorofim with the maximum total daily dose of 300 mg.


Treatment: Drugs: Olorofim
30mg oral tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Data Review Committee (DRC) Adjudicated Overall Response at Day 42
Timepoint [1] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [1] 0 0
DRC Adjudicated Overall Response at Day 42 for All Aspergillus
Timepoint [1] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [2] 0 0
DRC Adjudicated Overall Response at Day 42 for Lomentospora Prolificans
Timepoint [2] 0 0
Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment Day 42 in the Main Phase of study treatment
Secondary outcome [3] 0 0
DRC Adjudicated Overall Response at Day 42 for for Scedosporium Species
Timepoint [3] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [4] 0 0
DRC Adjudicated Overall Response at Day 42 for Coccidioides Species
Timepoint [4] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [5] 0 0
DRC Adjudicated Overall Response at Day 42 for Other Olorofim Susceptible Fungi
Timepoint [5] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [6] 0 0
DRC Adjudicated Overall Response at Day 84
Timepoint [6] 0 0
Day 84 in the Main Phase of study treatment
Secondary outcome [7] 0 0
Investigator Assessed Overall Response at Day 42
Timepoint [7] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [8] 0 0
Investigator Assessed Overall Response at Day 84
Timepoint [8] 0 0
Day 84 in the Main Phase of study treatment
Secondary outcome [9] 0 0
DRC Adjudicated Clinical Response at Day 42
Timepoint [9] 0 0
Day 42 in the Main phase of study treatment
Secondary outcome [10] 0 0
DRC Adjudicated Clinical Response at Day 84
Timepoint [10] 0 0
Day 84 in the Main phase of study treatment
Secondary outcome [11] 0 0
Investigator Assessed Clinical Response at Day 42
Timepoint [11] 0 0
Day 42 in the Main phase of study treatment
Secondary outcome [12] 0 0
Investigator Assessed Clinical Response at Day 84
Timepoint [12] 0 0
Day 84 in the Main Phase of study treatment
Secondary outcome [13] 0 0
DRC Adjudicated Mycological Response at Day 42
Timepoint [13] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [14] 0 0
DRC Adjudicated Mycological Response at Day 84
Timepoint [14] 0 0
Day 84 in the Main phase of study treatment
Secondary outcome [15] 0 0
Investigator Assessed Mycological Response at Day 42
Timepoint [15] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [16] 0 0
Investigator Assessed Mycological Response at Day 84
Timepoint [16] 0 0
Day 84 in the Main Phase of study treatment
Secondary outcome [17] 0 0
DRC Adjudicated Radiological Response at Day 42
Timepoint [17] 0 0
Day 42 in the Main phase of study treatment
Secondary outcome [18] 0 0
DRC Adjudicated Radiological Response at Day 84
Timepoint [18] 0 0
Day 84 in the Main Phase of study treatment
Secondary outcome [19] 0 0
Investigator Assessed Radiological Response at Day 42
Timepoint [19] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [20] 0 0
Investigator Assessed Radiological Response at Day 84
Timepoint [20] 0 0
Day 84 in the Main Phase of study treatment
Secondary outcome [21] 0 0
All Cause Mortality Rate at Day 42
Timepoint [21] 0 0
Day 42 in the Main Phase of study treatment
Secondary outcome [22] 0 0
All Cause Mortality Rate at Day 84
Timepoint [22] 0 0
Day 84 in the Main Phase of study treatment

Eligibility
Key inclusion criteria
* Male and female aged at least 18 years, or male and female aged 16 years or 17 years and who weigh at least 40 kg whom have given informed consent
* Ability and willingness to comply with the protocol.
* Able to take oral medication
* Females must be non-lactating and at no risk of pregnancy
* Male with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception
* Participants with invasive fungal disease
* Participants who have limited alternative treatment options
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant or breastfeeding.
* Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
* Participants with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis.
* Human Immunodeficiency Virus (HIV) infection but not currently receiving antiretroviral therapy.
* Participants with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the participant
* Previously enrolled participants or participants enrolled in any clinical trial within the last 30 days
* Participants receiving treatment limited to supportive care due to predicted short survival time.
* Prohibited concomitant medications.
* Any exclusion criteria required by local regulatory authorities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/02/2023
Sample size
Target
Accrual to date
Final
203
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Peter MacCallum Centre-East Melbourne - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
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
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Waals-Brabant
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Brazil
State/province [14] 0 0
Minas Gerais
Country [15] 0 0
Brazil
State/province [15] 0 0
Paraná
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio Grande Do Sul
Country [17] 0 0
Brazil
State/province [17] 0 0
Curitiba
Country [18] 0 0
Brazil
State/province [18] 0 0
Passos
Country [19] 0 0
Egypt
State/province [19] 0 0
Alexandria
Country [20] 0 0
Egypt
State/province [20] 0 0
Cairo
Country [21] 0 0
Egypt
State/province [21] 0 0
Mansoura
Country [22] 0 0
France
State/province [22] 0 0
Bas Rhin
Country [23] 0 0
France
State/province [23] 0 0
Isere
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Paris cedex 10
Country [26] 0 0
Germany
State/province [26] 0 0
Bayern
Country [27] 0 0
Germany
State/province [27] 0 0
Nordrhein Westfalen
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Israel
State/province [29] 0 0
Beer-Sheva
Country [30] 0 0
Israel
State/province [30] 0 0
Haifa
Country [31] 0 0
Israel
State/province [31] 0 0
Jerusalem
Country [32] 0 0
Israel
State/province [32] 0 0
Ramat Gan
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Aviv
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Netherlands
State/province [35] 0 0
Nijmegen
Country [36] 0 0
Netherlands
State/province [36] 0 0
Rotterdam
Country [37] 0 0
Netherlands
State/province [37] 0 0
Utrecht
Country [38] 0 0
Poland
State/province [38] 0 0
Gdansk
Country [39] 0 0
Poland
State/province [39] 0 0
Krakow
Country [40] 0 0
Poland
State/province [40] 0 0
Slupsk
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Saint Petersburg
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Valencia
Country [46] 0 0
Thailand
State/province [46] 0 0
Bangkok
Country [47] 0 0
Turkey
State/province [47] 0 0
Diyarbakir
Country [48] 0 0
Turkey
State/province [48] 0 0
Istanbul
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Greater London
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Greater Manchester
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Wythenshawe
Country [52] 0 0
Vietnam
State/province [52] 0 0
Hanoi
Country [53] 0 0
Vietnam
State/province [53] 0 0
Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon Chen
Address 0 0
Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daniea Zinzi
Address 0 0
Country 0 0
Phone 0 0
43 664 3582281
Fax 0 0
Email 0 0
dzinzi@f2g.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results can be available to researchers after the primary publication of results for this study, after deidentification (text, tables, figures, appendices)

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
From 3 months after publication of the primary manuscript (no end date)
Available to whom?
Requests should be directed to F2G for review.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03583164