Clinical Trials Logo
  1. Home
  2. Invasive Fungal Infections
  3. NCT03583164
  4. Details
NCT03583164 Clinical Trial

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

Invasive Fungal Infections Clinical Trial

— FORMULA-OLS  

Official title:
Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03583164
Other study ID # F901318/0032
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 6, 2018
Est. completion date April 2023

Study information
Verified date November 2022
Source F2G Biotech GmbH
Contact Daniea Zinzi
Phone 43 664 3582281
Email dzinzi@f2g.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

This is the first study in patients of F901318. Patients with a limited treatment options will be enrolled and treated with F901318 (olorofim) for up to 12 weeks.

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• F901318
30mg tablets with a maximum daily dose of 300mg with dose adjustments according to plasma levels of F901318 and concomitant treatment with CYP inducers or inhibitors
See more »

Sponsors (2)
Lead Sponsor Collaborator
F2G Biotech GmbH Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  Vietnam,  Australia,  Belgium,  Brazil,  Egypt,  France,  Germany,  Israel,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Spain,  Thailand,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary DRC adjudicated overall response at Day 42 using a combination of clinical, mycological and radiological response DRC adjudicated overall response at Day 42 using a combination of clinical, mycological using a combination of clinical, mycological and radiological results Day 42
Secondary DRC adjudicated response at other time points, investigator assessed overall response, all cause mortality. Assessment of overall response will be based on all available assessments (clinical, radiological and mycological). See response assessments listed below.
Treatment "success" is defined as complete or partial.
Treatment "failure" is defined as stable response or progression of IFD. The criteria for assessment of overall response are summarised below:
Success -complete, Success -partial, Failure -stable, Failure -progression.		 Days 7, 14, 28, End Of Treatment (anytime during the study between first administration and Day 84), 84 and 4-week FU
Secondary Clinical response The Investigator will identify and assess clinical signs and symptoms related to the IFD reported for each patient. Response assessment will be based on changes from baseline signs and symptoms 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
Secondary Where appropriate for the IFD, radiological response As relevant for the IFD under study, baseline radiological assessments of IFD will be performed at screening and during the course of the study in accordance with local practice and as clinically indicated.
A = 90% improvement.
A = 50 to < 90% improvement.
A = 25% to < 50% improvement.
No Change to < 25% improvement.
Worsening in aggregate (across all lesions if more than one lesion).
No signs on radiological images at screening.
Results not available (i.e. assessment not performed at scheduled time-point).		 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
Secondary Mycological response by pathogen Assessment of mycological response as follows:
Eradication of original causative organism cultured or identified by histology/cytology at baseline and no emergence of new causative organisms.
Presumed eradication - missing documentation of eradication of causative organism and no evidence of new causative organisms + resolution of all or some clinical symptoms and physical findings of IFD.
Persistence of the original causative organism cultured or identified by histology/cytology at baseline or emergence of a new causative organism.
Presumed persistence - missing documentation of persistence of causative organism and no documentation of emergence of new causative organisms + either (i) no resolution or (ii) worsening of any clinical symptoms and physical findings of IFD.
No mycological Follow-up results available (no diagnostic test done at the scheduled time-point).
No mycological evidence at baseline (negative diagnostic test(s) or not done).		 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
Secondary Investigator-assessed overall response (integration of clinical, radiological, and mycological response) see above. 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
Secondary All-cause mortality All-cause mortality will be assessed using survival status and, if applicable, death details will be recorded in the CRF Day 42, End Of Treatment (anytime during the study between first administration and Day 84), Day 84 and 4-week FU
See also
  Status Clinical Trial Phase
Completed NCT05749380 - Pharmacokinetics and Safety of AmBisome and DKF-5122 Phase 1
Not yet recruiting NCT02527928 - Cost-Effectiveness of Amphotericin B N/A
Completed NCT02851680 - Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia. N/A
Completed NCT03572049 - Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole Phase 2/Phase 3
Suspended NCT05534529 - Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age Phase 1
Completed NCT04024995 - Revision of Antifungal Strategies Definitions for Invasive Fungal Infections in Hematological Malignancies
Completed NCT00745992 - Voriconazole Blood Level and Liver Metabolizing Enzyme in Taiwanese Patients
Completed NCT06413056 - Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection Phase 4
Recruiting NCT05130723 - Pharmacokinetics of Fluconazole in Children (2-18 Years)
Recruiting NCT04157465 - Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients N/A
Completed NCT04122560 - Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration Phase 4
Completed NCT03262584 - Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients
Completed NCT02678598 - A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections N/A
Completed NCT05491733 - A Bioequivalence Study of APX001 High-load and Low-load Tablets Phase 1
Not yet recruiting NCT06220370 - PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.
Completed NCT04777058 - Pharmacokinetics of Isavuconazole in Patients in the Intensive Care Unit
Completed NCT03174457 - Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
Completed NCT00750737 - Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) Phase 3
Not yet recruiting NCT06346951 - Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS)
Recruiting NCT05750706 - Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative