NL-OMON56006尚未招募3 期
A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species - F901318/0041 OASIS Olorofim in Aspergillus Infection Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- F2G Ltd.
- 入组人数
- 10
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
- 18 至 99（—）
入选标准
- •1. Male and female patients ages >= 18 years and weighing >= 30 kg, [*] or
- •Patients unable to write and/or read but who fully understand the oral
- •information given by the Investigator.
- •2. Patients with proven IA at any site or probable LRTD IA per
- •EORTC/MSG 2019 criteria as adapted for this study (see Appendix 2) and where
- •the duration of specific therapy for this episode of IA has been <= 28 days. For
- •purposes of this inclusion, the duration of specific therapy includes any
- •mould-active therapy given for this episode of IA whether subsequently judged
- •potentially effective or not.
- •3. Patients requiring therapy with an antifungal agent other than a
- •mould-active azole and who have had <= 96 hours of potentially effective prior
- •therapy. Potentially effective prior therapy includes any agent to which the
- •infecting strain of Aspergillus is likely to be susceptible. There are no
- •exclusions or limitations on such agents (eg, AmBisome® is permitted) other
- •than their duration.
- •Patients must meet at least one of these criteria:
- •a) Proven or suspected azole resistance in patients who have had <= 96 hours of
- •potentially effective prior therapy [*]
- •b) Breakthrough infection on triazole prophylaxis: patients who have had any
- •duration of prophylaxis prior to the breakthrough but <= 96 hours of potentially
- •effective prior therapy.
- •c) Any other medical reason an azole is inappropriate for the patient at
- •screening. In all cases, patients must have had <= 96 hours of potentially
- •effective prior therapy
- •(potential for drug-drug interaction, previous history of azole intolerance)
- •d) Invasive aspergillosis refractory to triazole therapy in patients who have
- •had <= 28 days of prior therapy where refractory IA was defined per an
- •international expert meeting report
- •4. AmBisome® is an appropriate therapy for the patient.
- •a) For avoidance of doubt, prior therapy with an amphotericin B (eg, AmBisome®
- •or other) is not an exclusion provided that such prior therapy does not exceed
- •the rules for maximum duration of potentially effective prior therapy discussed
- •as part of Inclusion Criterion 3.
- •5. Ability and willingness to comply with the protocol.
- •6. Female patients must be non-lactating and at no risk of pregnancy [*]
- •7. Male patients with female partners of childbearing potential must either
- •totally abstain from sexual intercourse or use a highly effective means of
- •contraception.
- •For more details, please refer to the protocol.
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 (olorofim or AmBisome®).
- •3. Patients with only chronic aspergillosis, aspergilloma or allergic
- •bronchopulmonary aspergillosis.
- •4. Suspected mucormycosis (zygomycosis). Evidence for the presence of olorofim
- •non susceptible filamentous fungi such as Mucorales should be urgently followed
- •up. Increased vigilance for the possibility of mucormycosis (zygomycosis) is
- •required for suspected IA with negative baseline GM.
- •5. Patients with a known active second fungal infection of any type, other than
- •candidiasis being treated with fluconazole.
- •6. The requirement for ongoing use of echinocandin as Candida prophylaxis (for
- •avoidance of doubt, prior use of an echinocandin is permitted; if ongoing
- •prophylaxis for Candida is needed, then fluconazole must be an acceptable
- •choice [see Section 5.8.4.1, discussion of concomitant antifungal agents]).
- •7. Microbiological findings (eg, bacteriological, virological) or other
- •potential conditions that are temporally related and suggest a different
- •aetiology for the clinical features.
- •8. Patients with human immunodeficiency virus (HIV) infection who are currently
- •not receiving antiretroviral therapy. Patients with HIV infection receiving
- •antiretroviral therapy can participate in the study. 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 enrolment, then such
- •patients are eligible for enrolment.
- •9. Any known or suspected condition of the patient that may jeopardize
- •adherence to the protocol requirements or impede the accurate measurement of
- •efficacy (eg, neutropenia not expected to resolve, patients with uncontrolled
- •malignancy who are treatment refractory and receiving only palliative therapy).
- •10. 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.
- •11. Patients previously enrolled in a study with olorofim/F901318.
- •12. 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 (eg, open-label oncological regimen variations or biologic studies).
- •Prior to enrolling patients who 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.
- •13. Patients receiving treatment limited to supportive care due to predicted
- •short survival time.
- •14. Patients with a baseline prolongation of Fridericia's Correction Formula
- •(QTcF) >= 500 msec, or at high risk for QT/QTc prolongation.
- •15. Evidence of hepatic dysfunction with any of the following abnormal
- •laboratory parameters at screening (for avoidance of doubt, liver transplant
- •recipients may be enrolled if their laboratory parameters do not meet the
- •exclusions):
- •a) Total bilirubin >= 2 × upper limit of the normal range (ULN)
- •b) Alanine transaminase or aspartate transaminase (AST) >= 3 × ULN
- •c) Patients with known cirrhosis or chronic hepatic failure (regardless of
- •ALT/AST/total bilirub
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