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Antifungal Agent

Olorofim (F901318) for Fungal Infection (FORMULA-OLS Trial)

Phase 2
Waitlist Available
Led By Sharon Chen
Research Sponsored by F2G Biotech GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 42 in the main phase of study treatment day 42 in the main phase of study treatment day 42 in the main phase of study treatment day 42 in the main phase of study treatment day 42 in the main phase of study treatment
Awards & highlights

Summary

This trial is testing a new drug called olorofim for patients with serious fungal infections who have no other treatment options. The drug works by attacking and eliminating the fungus causing the infection. Patients will be treated with olorofim for a few months.

Eligible Conditions
  • Fungal Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 42 in the main phase of study treatment day 42 in the main phase of study treatment day 42 in the main phase of study treatment day 42 in the main phase of study treatment day 42 in the main phase of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 42 in the main phase of study treatment day 42 in the main phase of study treatment day 42 in the main phase of study treatment day 42 in the main phase of study treatment day 42 in the main phase of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Data Review Committee (DRC) Adjudicated Overall Response at Day 42
Secondary study objectives
All Cause Mortality Rate at Day 42
All Cause Mortality Rate at Day 84
DRC Adjudicated Clinical Response at Day 42
+19 more

Side effects data

From 2023 Phase 2 trial • 203 Patients • NCT03583164
21%
Diarrhoea
20%
Nausea
20%
Vomiting
16%
Headache
14%
Pyrexia
11%
Liver function test increased
9%
Fatigue
9%
Hepatic enzyme increased
9%
Oedema peripheral
9%
Cough
9%
COVID-19
8%
Hypotension
8%
Hypokalaemia
8%
Urinary tract infection
7%
Acute kidney injury
7%
Constipation
7%
Back pain
7%
Decreased appetite
7%
Arthralgia
7%
Dyspnoea
6%
Depression
6%
Abdominal pain
6%
Pain in extremity
6%
Pneumonia
6%
Hyponatraemia
6%
Anaemia
5%
Hyperkalaemia
5%
Hypertension
5%
Rash
4%
Respiratory failure
2%
Aspergillus infection
2%
Septic shock
2%
Seizure
2%
Acute respiratory failure
2%
Meningitis coccidioides
1%
Acute myeloid leukaemia
1%
Hydrocephalus
1%
Pleural effusion
1%
Pneumonia viral
1%
Sepsis
1%
Cerebrovascular accident
1%
Urosepsis
1%
Atrial fibrillation
1%
Post transplant lymphoproliferative disorder
1%
Bacterial infection
1%
Deep vein thrombosis
1%
Device malfunction
1%
Fungal infection
1%
Haemoptysis
1%
Pulmonary sepsis
1%
Pulseless electrical activity
1%
Subarachnoid haemorrhage
1%
Neutropenia
1%
Cerebral haemorrhage
1%
Disseminated coccidioidomycosis
1%
Hypoxia
1%
Pulmonary embolism
1%
Coccidioidomycosis
1%
Postoperative wound infection
1%
Complications of transplanted lung
1%
Cytomegalovirus viraemia
1%
Device related sepsis
1%
Acute myeloid leukaemia refractory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olorofim (F901318)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Olorofim (F901318)Experimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Olorofim
2021
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

F2G Biotech GmbHLead Sponsor
20 Previous Clinical Trials
1,636 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
112 Previous Clinical Trials
173,430 Total Patients Enrolled
Sharon ChenPrincipal InvestigatorWestmead Hospital
~28 spots leftby Sep 2025
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