A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
- Conditions
- invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungiTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-001290-17-ES
- Lead Sponsor
- F2G Ltd.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
1. Male and female patients aged at least 18 years who have been fully informed and who have given voluntary written informed consent, or whose legally authorized representative(s) have been fully informed and have given voluntary written informed consent if applicable, OR: Patients unable to write and / or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed consent witnessed in writing by an independent person and in compliance with local regulations.
2. Ability and willingness to comply with the protocol.
3. Patients must be able to take oral medication
4. Female patients must be non-lactating and at no risk of pregnancy for one of the following criteria:
a. Postmenopausal for at least 1 year;
b. Post-hysterectomy and/or post-bilateral ovariectomy;
c. Of childbearing potential, with a negative urine or serum human chorionic gonadotropin pregnancy test at the Screening visit and must be using a highly effective method of birthcontrol (hormonal implants, oral or injected hormonal contraceptives, intrauterine devices, two barrier methods such as a condom and a cervical cap) throughout the course of the study period. Reliable sexual abstinence is acceptable as a highly effective method of birth control for the purposes of this study. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.
5. Male patients with female partners of childbearing potential must either abstain from sexual intercourse or use a reliable means of contraception throughout study participation and agree to continue its use for 30 days after stopping study drug.
6. Patients with one of these 4 forms of invasive fungal infection confirmed by culture or other diagnostic (as agreed with the MM):
a) Lomentospora (Scedosporium) prolificans (LoPro),
b) Scedosporium spp.,
c) Aspergillus spp.,
d) Other F901318-susceptible fungi (as described in the IB or based on information provided by the MM, and in either case requiring approval of the MM),
OR
e) Probable IA-LRTD based on EORTC/MSG criteria (Appendix 2) but not meeting the criteria for culture proven invasive fungal infection.
7. Patients will also have limited alternative treatment options based on meeting one or more of the following criteria:
a) Known or predicted resistance of the infecting isolate to all licensed agents. LoPro automatically meets this criterion – other fungi may qualify after discussion with the MM,
b) Failure of available therapy. Failure to improve based on clinical or radiologic grounds despite receiving =7 days of standard antifungal treatment AND alternative licensed agents are either predicted to be ineffective or are contraindicated,
c) Intolerance to available therapy. Current therapy cannot be continued due to therapy-related adverse reactions (e.g., increase in serum creatinine above upper limit of normal with an amphotericin, persistent visual disturbances with voriconazole, allergic reaction with any compound, or other recognized drug-related AE) AND alternative licensed agents are either predicted to be ineffective or are contraindicated, d) Inability to manage DDIs. Inability to continue current therapy due to DDIs that cannot be managed AND alternative licensed agents are either predicted to be ineffective or are contraindicated,
e) Inability to produce therapeutic drug levels. Inability to pr
1. Women who are pregnant or breastfeeding.
2. Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
3. Patients with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis.
4. Suspected zygomycosis. Evidence for the presence of F901318 non-susceptible filamentous fungi such as Mucorales should be urgently followed up and treatment should not be started or adapted. In particular, suspected IA with negative baseline GM should generally trigger increased vigilance.
5. Microbiological findings (e.g., virological) or other potential conditions that are temporally related and suggest a different etiology for the clinical features.
6. HIV infection but not currently receiving antiretroviral therapy.7. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy (e.g. neutropenia not expected to resolve, patients with endocarditis, patients with uncontrolled malignancy who are treatment refractory and receiving only palliative therapy).
8. Patients with a concomitant medical condition that, in the opinion of the Investigator, may be an unacceptable additional risk to the patient should he / she participate in the study.
9. Patients previously enrolled in a study with F901318.
10. Treatment with any investigational drug in any clinical trial within the 30 days prior to the first administration of study drug except for unblinded protocols (e.g. open-label oncological regimen variations or biologic studies). Prior to enrolling patients that are on other open label studies it is the site’s responsibility to ensure that the study criteria for that study allow for enrolment into this study.
11. Patients receiving treatment limited to supportive care due to predicted short survival time.
12. Patients with a baseline prolongation of QTcF =500 msec, or at high risk for QT/QTc prolongation, e.g.a) A family history of long QT syndrome
b) Other known pro-arrhythmic conditions
c) Risk factors for Torsade de Pointes (e.g. uncompensated heart failure, abnormal plasma potassium or magnesium levels that cannot be corrected, an unstable cardiac condition during the last 30 days).
d) Use of concomitant medications that prolong the QT/QTc interval.
13. Evidence of hepatic dysfunction with any of the following abnormal laboratory parameters at Screening:
a) Total bilirubin =2 x ULN
b) Alanine transaminase or aspartate transaminase =3 x ULN
c) Patients with known cirrhosis or chronic hepatic failure
14. Prohibited concomitant medications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method