CompletedPhase 2

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

United States, Australia, Belgium203 participantsStarted 2018-06-06

Plain-language summary

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

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Data Review Committee (DRC) Adjudicated Overall Response at Day 42

Timeframe: Day 42 in the Main Phase of study treatment

Trial details

NCT IDNCT03583164

SponsorF2G Biotech GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-10

Results submitted2024-06-13

View on ClinicalTrials.gov More Invasive Fungal Infections trials

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.