Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options

Completed · Phase 2

Conditions studied: Invasive Fungal Infections

In brief

A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.

Key facts

Study ID

NCT03583164

Run by

F2G Biotech GmbH

People needed

203

Starts

2018-06-06

Expected to finish

2023-02-10

Last updated by the study team

2024-07-10

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Any exclusion criteria required by local regulatory authorities.

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Weill Cornell Medical College — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Duke University Health System — Durham, North Carolina, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Westmead Hospital — Westmead, New South Wales, Australia
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
• Peter MacCallum Centre-East Melbourne — Melbourne, Victoria, Australia
• Royal Melbourne Hospital — Melbourne, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• UZ Leuven — Leuven, Waals-Brabant, Belgium
• Institut Jules Bordet — Brussels, Belgium
• Hôpital Erasme — Brussels, Belgium
• Hospital Felício Rocho — Belo Horizonte, Minas Gerais, Brazil
• Santa Casa de Misericórdia de Belo Horizonte — Belo Horizonte, Minas Gerais, Brazil
• Valley Fever Institute at Kern Medical Center — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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