Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
FORMULA-OLS
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
1 other identifier
interventional
203
17 countries
82
Brief Summary
A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
Longer than P75 for phase_2
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2018
CompletedStudy Start
First participant enrolled
June 6, 2018
CompletedFirst Posted
Study publicly available on registry
July 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2023
CompletedResults Posted
Study results publicly available
July 10, 2024
CompletedJuly 10, 2024
July 1, 2024
4.7 years
May 17, 2018
June 13, 2024
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Data Review Committee (DRC) Adjudicated Overall Response at Day 42
The primary efficacy variable was the DRC-adjudicated overall response at the Day 42 Study Visit, as determined by an independent DRC using a combination of clinical, mycological, and radiological results based on European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. For the primary statistical analysis of overall response rate, values were assigned to the DRC adjudicated overall response as follows: Success (Success-Complete, Success-Partial); Failure (Failure-Stable, Failure-Progression, Death, and participants for whom data at the Day 42 Study Visit could not be collected or participants who were considered not evaluable at the Day 42 Study Visit).
Day 42 in the Main Phase of study treatment
Secondary Outcomes (22)
DRC Adjudicated Overall Response at Day 42 for All Aspergillus
Day 42 in the Main Phase of study treatment
DRC Adjudicated Overall Response at Day 42 for Lomentospora Prolificans
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
DRC Adjudicated Overall Response at Day 42 for for Scedosporium Species
Day 42 in the Main Phase of study treatment
DRC Adjudicated Overall Response at Day 42 for Coccidioides Species
Day 42 in the Main Phase of study treatment
DRC Adjudicated Overall Response at Day 42 for Other Olorofim Susceptible Fungi
Day 42 in the Main Phase of study treatment
- +17 more secondary outcomes
Study Arms (1)
Olorofim (F901318)
EXPERIMENTALOlorofim (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- F2G Biotech GmbHlead
- Iqvia Pty Ltdcollaborator
Study Sites (82)
Valley Fever Institute at Kern Medical Center
Bakersfield, California, 93306, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
University of California San Diego Medical Center
San Diego, California, 92103, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794-0001, United States
Duke University Health System
Durham, North Carolina, 27710, United States
UPMC
Pittsburgh, Pennsylvania, 15213, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Peter MacCallum Centre-East Melbourne
Melbourne, Victoria, 3000, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
UZ Leuven
Leuven, Waals-Brabant, 3000, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Hôpital Erasme
Brussels, 1070, Belgium
Hospital Felício Rocho
Belo Horizonte, Minas Gerais, 30110-934, Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221, Brazil
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, 80060-900, Brazil
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital da Universidade Federal de Santa Maria CEP/UFSM
Santa Maria, Rio Grande do Sul, 97105-900, Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, 81520-060, Brazil
Santa Casa de Misericórdia de Passos
Passos, 37904-020, Brazil
Oncology Center, Mansoura University
Al Mansurah, 35516, Egypt
Alexandria University Hospital
Alexandria, 21131, Egypt
Cairo University Hospitals
Cairo, 11559, Egypt
Ain Shams University Hospital
Cairo, 11566, Egypt
Air Force Specialized Hospital
Cairo, 11566, Egypt
National Cancer Institute
Cairo, 11796, Egypt
Nasser Institute
Cairo, 12655, Egypt
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, Bas Rhin, 67091, France
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, Isere, 38043, France
Hôpital Necker - Enfants Malades
Paris, Paris, 75015, France
Hôpital Saint-Louis
Paris, 75475, France
Klinikum der Universitaet Muenchen Campus Grosshadern
Munich, Bavaria, 81377, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937, Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200, Germany
Charite-Campus Benjamin Franklin (CBF)
Berlin, 12200, Germany
Soroka University Medical Center
Beersheba, 84001, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001, Israel
Chaim Sheba Medical Center
Ramat Gan, 52363, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Radboudumc
Nijmegen, 6525 GA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 CE, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
Słupsk, 76-200, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776, Poland
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint Petersburg, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Russia
SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RH
Saint Petersburg, Russia
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46021, Spain
Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330, Thailand
Dicle University, Medical Faculty
Diyarbakır, 21280, Turkey (Türkiye)
Acibadem Atakent Hospital
Istanbul, 34303, Turkey (Türkiye)
Marmara University Pendik Research and Training Hospital
Istanbul, 34899, Turkey (Türkiye)
King's College Hospital
London, Greater London, SE5 9NU, United Kingdom
Manchester Royal Infirmary
Manchester, Greater Manchester, M13 9WL, United Kingdom
Wythenshawe Hospital
Manchester, Wythenshawe, M23 9LT, United Kingdom
Bach Mai Hospital
Hanoi, 100000, Vietnam
National Lung Hospital
Hanoi, 10000, Vietnam
HCMC Hospital for Tropical Diseases
Ho Chi Minh City, 00000, Vietnam
Blood Transfusion Hematology Hospital
Ho Chi Minh City, 0000, Vietnam
Related Publications (1)
Maertens JA, Thompson GR 3rd, Spec A, Donovan FM, Hammond SP, Bruns AHW, Rahav G, Shoham S, Johnson R, Rijnders B, Schaenman J, Hoenigl M, Morrissey CO, Mehta SR, Heath CH, Koehler P, Paterson DL, Slavin MA, Fortun J, Nguyen MH, Patterson TF, Uspenskaya O, Van de Veerdonk FL, Verweij PE, Aoun M, Georgala A, Alexander BD, Chayakulkeeree M, Mehra V, Miceli MH, Sikka MK, Sole A, Walsh TJ, Aguado JM, Holland SM, Moussa M, Rautemaa-Richardson R, Bazaz R, Schwartz S, Walsh SR, Plate M, Yehudai-Ofir D, Bruggemann RJ, Cornely OA, Ostrosky-Zeichner L, Vazquez JA, White PL, Cornelissen K, Ross GG, Fitton L, Dane A, Zinzi D, Rex JH, Chen SC. Olorofim for the treatment of invasive fungal diseases in patients with few or no therapeutic options: a single-arm, open-label, phase 2b study. Lancet Infect Dis. 2025 Nov;25(11):1177-1188. doi: 10.1016/S1473-3099(25)00224-5. Epub 2025 Jun 18.
PMID: 40541222DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniela Zinzi
- Organization
- F2G Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Chen
Westmead Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2018
First Posted
July 11, 2018
Study Start
June 6, 2018
Primary Completion
February 10, 2023
Study Completion
February 10, 2023
Last Updated
July 10, 2024
Results First Posted
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- From 3 months after publication of the primary manuscript (no end date)
- Access Criteria
- Requests should be directed to F2G for review.
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)