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

F2G Biotech

Status and phase: Completed; Phase 2

Conditions: Invasive Fungal Infections

Treatments: Drug: Olorofim

Study type: Interventional

Funder types: Industry

Identifiers

NCT03583164

F901318/0032

Details and patient eligibility

About

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

Full description

An open label, single arm Phase IIb study of olorofim (F901318) in participants with invasive fungal infections with limited treatment options. Participants received study treatment for up to 12 weeks in the main phase of the study. At the Investigator's request and after discussion with the medical monitor, open-label treatment with F901318 could be continued in patients judged by the Investigator to need therapy beyond 84 days and considered likely to continue to benefit from extended treatment.

Enrollment: 203 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 1 patient group

Olorofim (F901318)

Experimental group

Description:

Olorofim (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.

Treatment:

Drug: Olorofim