← Back to Search

Antifungal Agent

F901318 for Fungal Infection (FORMULA-OLS Trial)

Phase 2

Recruiting

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 7, day 14, day 28, day 42, end of treatment (anytime during the study between first administration and day 84), day 84 and 4-week fu

Awards & highlights

FORMULA-OLS Trial Summary

This trial is testing a new drug to see if it is effective in treating patients with a serious fungal infection when there are no other suitable treatment options.

Eligible Conditions

Fungal Infection

FORMULA-OLS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7, day 14, day 28, day 42, end of treatment (anytime during the study between first administration and day 84), day 84 and 4-week fu

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7, day 14, day 28, day 42, end of treatment (anytime during the study between first administration and day 84), day 84 and 4-week fu

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, day 14, day 28, day 42, end of treatment (anytime during the study between first administration and day 84), day 84 and 4-week fu for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DRC adjudicated overall response at Day 42 using a combination of clinical, mycological and radiological response

Secondary outcome measures

All-cause mortality

Clinical response

DRC adjudicated response at other time points, investigator assessed overall response, all cause mortality.

+3 more

Side effects data

From 2014 Phase 1 trial • 40 Patients • NCT02142153

17%

Paraesthesia

100%

80%

60%

40%

20%

Study treatment Arm

F901318 0.75 mg/kg

F901318 1.5 mg/kg

0.25 mg/kg Placebo

F901318 0.25 mg/kg

Placebo 0.75 mg/kg

Placebo 3 mg/kg

F901318 3 mg/kg

Placebo 1.5 mg/kg

Placebo 4 mg/kg

F901318 4 mg/kg

FORMULA-OLS Trial Design

1Treatment groups

Experimental Treatment

Group I: F901318Experimental Treatment1 Intervention

open-label single-arm of F901318 as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi which are susceptible to F901318 in patients with limited treatment options.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

F901318

2014

Completed Phase 1

~180

Do I qualify?Apply below to find out

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

107 Previous Clinical Trials

169,868 Total Patients Enrolled

Sharon ChenPrincipal InvestigatorWestmead Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous sites in North America conducting this research study?

"This medical study is currently in operation at 14 sites, including Sacramento, Bakersfield and Stony Brook. It may be of benefit to choose the nearest location possible if you are considering taking part in this trial in order to minimize travel demands."

Answered by AI

What is the maximal capacity of participants in this experiment?

"To conduct this medical trial, 200 qualified individuals are needed. These participants can be recruited from the UC Davis Medical Center in Sacramento, California and Valley Fever Institute at Kern Medical Center in Bakersfield, New york."

Answered by AI

To what extent do people run the risk of harm when exposed to F901318?

"The safety of F901318 has been evaluated with a score of 2 based on the Phase 2 nature of this trial. While there is preliminary evidence for its security, efficacy data is yet to be collected."

Answered by AI

Are there any unfilled positions remaining in this research endeavor?

"Per clinicaltrials.gov, this research study is presently seeking potential participants. First published on June 6th 2018 and recently edited on November 30th 2022, the trial has an ongoing recruitment process."

Answered by AI

Has F901318 been previously investigated for its therapeutic potential?

"F901318 was researched in 2018 by the National Cancer Institute and has seen 12 trials through to completion. At present, Sacramento, California is hosting two recruiting studies for this medication."

Answered by AI

Has this trial been previously conducted or is it a novel undertaking?

"At the moment, two ongoing proceedings concerning F901318 are taking place in 35 cities around 17 nations. This drug was initially tested back in 2018 by F2G Biotech GmbH with a cohort of 200 individuals during its Phase 2 medicinal approval stage; since then 12 trials have been concluded."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options

2018. "Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03583164.

All > Rsv