NL-OMON52686已完成2 期
An open-label single-arm 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. - FORMULA-OLS:F901318
F2G Biotech GmbH (FN 483749 x)0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •1. Male and female patients aged at least 18 years or male and female patients
- •aged 16 years or 17 years and who weigh at least 40 kg 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 and in compliance with local
- •regulations, OR: Patients unable to write and / or read but who fully
- •understand the oral information
- •given by the Investigator 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. 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 throughout
- •of the study period:
- •i) Established use of oral, injected, transdermal, intravaginal or
- •implanted hormonal methods of contraception associated with inhibition
- •of ovulation
- •ii) Placement of an intrauterine device or intrauterine hormone-releasing
- •iii) Male sterilisation (with the appropriate post-vasectomy
- •documentation of the absence of sperm in the ejaculate
- •iv) Bilateral tubal occlusion
- •v) Sexual abstinence (reliable sexual abstinence is acceptable but
- •periodic abstinence [e.g. calendar, ovulation, symptom-thermal, or post
- •ovulation methods] and withdrawal are not acceptable)., 4. Male patients with
- •female partners of childbearing potential must either totally abstain from
- •sexual intercourse or use a highly effective means of contraception throughout
- •study participation and agree to continue its use for 30 days after stopping
- •study drug., 5. 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 LRTD IA based on EORTC/MSG criteria
- •(Appendix 2) but not meeting the criteria for culture proven invasive fungal
- •*For further details on inclusion criterium 6, see the protocol footnote, 6.
- •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, p
排除标准
- •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 (mucormycosis) as the
- •IFD used to quality for the study. Evidence for the presence of F901318
- •non-susceptible filamentous fungi such as Mucorales should be urgently followed
- •up. Increased vigilance for the possibility of zygomycosis is required for
- •suspected IA with negative baseline GM., 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.In
- •cases where HIV infection is first diagnosed at the same time as the
- •invasive fungal infection, if antiretroviral therapy is commenced at the
- •time of enrollment, then such patients are eligible for enrollment., 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 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).,
- •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.
- •Concomitant administration of inhibitors of human DHODH (teriflunomide and
- •leflunomide) is prohibited. There are currently no other absolutely prohibited
- •concomitant medications but there are medications with potentially significant
- •DDIs and the management of potential interactions should be considered before
- •study enrollment (Section 5.9.1)., 15. Additional exclusion criteria required
- •by local regulatory or legal order.
- •- Prisoners or subjects who are legally institutionalized.
- •- Patients who are not suitable for participation, whatever the
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