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 : December 1, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Invasive Fungal Infections||Drug: F901318||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||September 2, 2022|
|Estimated Study Completion Date :||April 2023|
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.
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
- 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
- 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
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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
|Contact: Daniea Zinzi||43 664 firstname.lastname@example.org|
|Principal Investigator:||Sharon Chen||Westmead Hospital|
|Responsible Party:||F2G Biotech GmbH|
|Other Study ID Numbers:||
|First Posted:||July 11, 2018 Key Record Dates|
|Last Update Posted:||December 1, 2022|
|Last Verified:||November 2022|
|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|
Invasive Fungal Infections
Bacterial Infections and Mycoses