Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
225 participants
INTERVENTIONAL
2022-03-31
2026-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
NCT03583164
Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment
NCT00158730
A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).
NCT00037206
Single Ascending Oral Dose Study of F901318
NCT02394483
Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis
NCT00047827
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Olorofim
Olorofim versus AmBisome followed by Standard of Care (SOC)
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)
AmBisome
Olorofim versus AmBisome followed by Standard of Care (SOC)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Iqvia Pty Ltd
INDUSTRY
Shionogi
INDUSTRY
F2G Biotech GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Johan Maertens, MD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
University of California Davis Health System
Sacramento, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
Augusta University
Augusta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
NIH Clinical Center ,NIAID,NIH
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Clairvoyant Research Group, LLC
Las Vegas, Nevada, United States
Rutgers RWJMS
New Brunswick, New Jersey, United States
Weill Cornell Medicine NY Presbyterian Hospital
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke Department of Medicine Infectious Diseases Division
Durham, North Carolina, United States
OU Health OU Medical Center
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States
Houston Methodist
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Royal NorthShore Hospital
Saint Leonards, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
AZ Sint-Jan
Bruges, , Belgium
Hôpital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Hospital Felício Rocho
Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais, Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital da Universidade Federal de Santa Maria CEP/UFSM
Santa Maria, Rio Grande do Sul, Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
Hamilton Health Sciences - Juravinski Site
Hamilton, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Institute of Hematology and Blood Diseases Hospital
Xiaobailou, Tianjin Municipality, China
The 1st Affiliated Hosp of Wenzhou Medical University
Wenzhou, Zhejiang, China
Peking University People's Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Xiangya Hospital, Central South University
Changsha, , China
Chenzhou No.1 People's Hospital
Chenzhou, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
Nanfang Hospital of Southern Medical University
Guangzhou, , China
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, , China
Shengjing Hospital of China Medical University
Shengyang, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
Xi'an International Medical Center
Xi'an, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Institut de Cancérologie de Strasbourg Europe - ICANS
Strasbourg, Bas Rhin, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, France
CHU de Besancon
Besançon, Doubs, France
CHU Bordeaux Hopital Saint André
Bordeaux, Gironde, France
Institut Universitaire du Cancer de Toulouse- IUCT-O
Toulouse, Haute Garonne, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France
CHU de Nantes CIC Hematologie
Nantes, Loire Atlantique, France
Hospital Claude Huriez
Lille, Nord, France
Hôpital Necker - Enfants Malades
Paris, Paris, France
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany
Charite Universitatsmedizin Berlin
Berlin, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
UKE Universitaetsklinikum-Hamburg Eppendorf
Hamburg-Eppendorf, , Germany
Soroka University Medical Center
Beersheba, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center Pt
Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Napoli, Campania, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Di Monza E Della Brianza, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Ospedale San Raffaele
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
AOU Policlinico di Modena
Modena, , Italy
Clinica Malattie Infettive Dipartimento di Medicina e Chirurgia dell'Università
Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Pisa, , Italy
Inmi Lazzaro Spallanzani Irccs
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Chiba University Hospital
Chiba, Chiba, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan
The Jikei University Hospital
Minato-Ku, Tokyo, Japan
Toranomon Hospital
Minatoku, Tokyo to, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyō City, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Okayama University Hospital
Okayama, , Japan
Saitama Medical Center Jichi Medical University
Saitama, , Japan
Jichi Medical University Hospital
Shimotsuke, , Japan
Radboud Nijmegen
Nijmegen, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Wellington Regional Hospital
Newtown, Wellington Region, New Zealand
Auckland City Hospital
Auckland, , New Zealand
National University Hospital
Singapore, , Singapore
Singapore General Hospital- Parent
Singapore, , Singapore
The Catholic University of Korea
Bucheon-si, Seoul, South Korea
Samsung Medical Center
Irwon-dong, Seoul, South Korea
Hospital General Universitario Gregorio Marañón
Retiro, Madrid, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Dicle University, Medical Faculty
Diyarbakır, , Turkey (Türkiye)
Acibadem Atakent Hospital
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.
Samsun, , Turkey (Türkiye)
University Hospital of Wales
Cardiff, Wales, United Kingdom
Kings College Hospital
London, , United Kingdom
Imperial College London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
F901318/0041
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.