Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treat… (NCT03583164) | Clinical Trial Compass
CompletedPhase 2
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
United States203 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 range16 Years
SexALL
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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.
What they're measuring
1
Data Review Committee (DRC) Adjudicated Overall Response at Day 42
Timeframe: Day 42 in the Main Phase of study treatment