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

Conditions

• Invasive Fungal Infections

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olorofim — DRUG
  30mg oral tablets

Study Details

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

Key Dates

Start date

Jun 6, 2018

Status verified

Jul 2024

Primary completion

Feb 10, 2023

Completion

Feb 10, 2023

Study Design

Enrollment

203 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Olorofim (F901318)
  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.

Primary Outcome Measure

Data Review Committee (DRC) Adjudicated Overall Response at Day 42 [ Time Frame: Day 42 in the Main Phase of study treatment ]

Locations (14)

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