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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 : September 8, 2021
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
F2G Biotech GmbH

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date September 8, 2021
Actual Study Start Date  ICMJE June 6, 2018
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • 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.
  • 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
  • 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).
  • 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).
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options
Official Title  ICMJE 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
Brief Summary A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Invasive Fungal Infections
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: F901318
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2021)
200
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
100
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female aged at least 18 years, or male and female aged 16 years or 17 years and who weigh at least 40 kg whom have given informed consent
  • Ability and willingness to comply with the protocol.
  • Able to take oral medication
  • Female must be non-lactating and at no risk of pregnancy
  • Male with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception
  • Patients with invasive fungal disease
  • Patients who have limited alternative treatment options

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.
  • Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
  • Patients with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis.
  • HIV infection but not currently receiving antiretroviral therapy.
  • Patients with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the patient
  • Previously enrolled patients or patients enrolled in any clinical trial within the last 30 days
  • Patients receiving treatment limited to supportive care due to predicted short survival time.
  • Prohibited concomitant medications.
  • Any exclusion criteria required by local regulatory authorities.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paul Newell 44 07766 130849 PNewell@f2g.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Egypt,   France,   Germany,   Israel,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Spain,   Thailand,   Turkey,   United Kingdom,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03583164
Other Study ID Numbers  ICMJE F901318/0032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party F2G Biotech GmbH
Study Sponsor  ICMJE F2G Biotech GmbH
Collaborators  ICMJE Iqvia Pty Ltd
Investigators  ICMJE
Principal Investigator: Sharon Chen Westmead Hospital
PRS Account F2G Biotech GmbH
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP