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Antifungal Agent
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options (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
No Placebo-Only Group
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 weeks3 visits
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
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
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 moreSide effects data
From 2023 Phase 2 trial • 203 Patients • NCT0358316421%
Diarrhoea
20%
Vomiting
20%
Nausea
16%
Headache
14%
Pyrexia
11%
Liver function test increased
9%
Oedema peripheral
9%
Fatigue
9%
Cough
9%
COVID-19
9%
Hepatic enzyme increased
8%
Urinary tract infection
8%
Hypokalaemia
8%
Hypotension
7%
Constipation
7%
Decreased appetite
7%
Dyspnoea
7%
Acute kidney injury
7%
Arthralgia
7%
Back pain
6%
Pain in extremity
6%
Depression
6%
Hyponatraemia
6%
Pneumonia
6%
Anaemia
6%
Abdominal pain
5%
Rash
5%
Hyperkalaemia
5%
Hypertension
4%
Respiratory failure
2%
Seizure
2%
Acute respiratory failure
2%
Aspergillus infection
2%
Meningitis coccidioides
2%
Septic shock
1%
Fungal infection
1%
Pulseless electrical activity
1%
Acute myeloid leukaemia
1%
Acute myeloid leukaemia refractory
1%
Atrial fibrillation
1%
Cerebral haemorrhage
1%
Deep vein thrombosis
1%
Haemoptysis
1%
Hydrocephalus
1%
Pneumonia viral
1%
Post transplant lymphoproliferative disorder
1%
Postoperative wound infection
1%
Pulmonary embolism
1%
Pulmonary sepsis
1%
Urosepsis
1%
Neutropenia
1%
Device malfunction
1%
Device related sepsis
1%
Disseminated coccidioidomycosis
1%
Bacterial infection
1%
Cerebrovascular accident
1%
Coccidioidomycosis
1%
Complications of transplanted lung
1%
Cytomegalovirus viraemia
1%
Hypoxia
1%
Pleural effusion
1%
Sepsis
1%
Subarachnoid haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olorofim (F901318)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
118 Previous Clinical Trials
176,627 Total Patients Enrolled
Sharon ChenPrincipal InvestigatorWestmead Hospital