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Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options (FORMULA-OLS)

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ClinicalTrials.gov Identifier: NCT03583164
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
IQVIA
Information provided by (Responsible Party):
F2G Ltd.

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

Condition or disease Intervention/treatment Phase
Invasive Fungal Infections Drug: F901318 Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: F901318
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.
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




Primary Outcome Measures :
  1. DRC adjudicated overall response at Day 42 using a combination of clinical, mycological and radiological response [ Time Frame: Day 42 ]
    DRC adjudicated overall response at Day 42 using a combination of clinical, mycological using a combination of clinical, mycological and radiological results


Secondary Outcome Measures :
  1. DRC adjudicated response at other time points, investigator assessed overall response, all cause mortality. [ Time Frame: Days 7, 14, 28, End Of Treatment (anytime during the study between first administration and Day 84), 84 and 4-week FU ]

    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.


  2. Clinical response [ Time Frame: 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 ]
    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

  3. Where appropriate for the IFD, radiological response [ Time Frame: 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 ]

    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).


  4. Mycological response by pathogen [ Time Frame: 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 ]

    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).


  5. Investigator-assessed overall response [ Time Frame: 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 ]
    (integration of clinical, radiological, and mycological response) see above.

  6. All-cause mortality [ Time Frame: Day 42, End Of Treatment (anytime during the study between first administration and Day 84), Day 84 and 4-week FU ]
    All-cause mortality will be assessed using survival status and, if applicable, death details will be recorded in the CRF



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female aged 18 or older whom have given informed consent
  • Ability to comply with the protocol
  • Females must be non lactating and not at risk of pregnancy
  • Patients with invasive fungal disease
  • Patients who have limited alternative treatment options

Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • Known history of allergy hypersensitivity to any study drug components
  • Patients with chronic aspergillosis
  • HIV patients who are not receiving antiretroviral therapy
  • Previously enrolled patients or patients enrolled in any clinical trial within the last 30 days
  • Patients with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the patient
  • Patients with predicted short survival time
  • Prohibited concomitant medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583164


Contacts
Contact: Paul Newell 44 07766 130849 PNewell@f2g.com

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Francisco Marty         
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Principal Investigator: Chen Sharon         
Australia, Victoria
Peter MacCallum Centre-East Melbourne Recruiting
Melbourne, Victoria, Australia, 3000
Principal Investigator: Monica Slavin         
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3000
Principal Investigator: Monica Slavin         
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Orla Morrissey         
Belgium
UZ Leuven Recruiting
Leuven, Waals-Brabant, Belgium, 3000
Principal Investigator: Johan Maertens         
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Principal Investigator: Mickael Aoun         
Netherlands
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, 3015 CE
Principal Investigator: Bart Jan An Rijnders         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Principal Investigator: Isabel Ruiz Camps         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Principal Investigator: Jesus Fortun Abete         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Principal Investigator: Jose Maria Aguado Garcia         
Hospital Universitari i Politecnic La Fe Recruiting
Valencia, Spain, 46021
Principal Investigator: Amparo Sole Jover         
Sponsors and Collaborators
F2G Ltd.
IQVIA
Investigators
Principal Investigator: Sharon Chen Westmead Hospital

Responsible Party: F2G Ltd.
ClinicalTrials.gov Identifier: NCT03583164     History of Changes
Other Study ID Numbers: F901318/0032
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by F2G Ltd.:
Anti fungal
Invasive aspergillosis
Rare moulds

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Invasive Fungal Infections