EUCTR2016-002271-97-DE进行中（未招募）1 期
An open label phase IIa clinical study to evaluate the safety and pharmacokinetics of oral F901318 (combined with fluconazole and posaconazole) for antifungal prophylaxis in patients undergoing chemotherapy for acute myeloid leukaemia (SAFEGUARD FP) - SAFEGUARD FP
F2G Limited0 个研究点目标入组 18 人开始时间: 2017年1月23日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients diagnosed with AML and entering treatment of chemotherapy.
- •2.Patients are expected to be neutropenic (< 500 ANC/µl) for > 10 days.
- •3.Provision of written informed consent prior to any study specific procedures.
- •4.Ability and willingness to comply with the protocol.
- •5.Patients aged over 18 years.
- •6.Patients with body weight =60 kg
- •7.Group F only: patient receives according to local clinical standard either
- •no fungal prophylaxis or
- •only topical fungal prophylaxis (e.g. Ampho moronal®) or
- •fluconazole as routine fungal prophylaxis
- •8.Group P only: patient receives posaconazole as fungal prophylaxis according to local clinical standard
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1.Documented lung infiltrate at screening.
- •2.Evidence for active fungal infection, such as documented serum GMI =0.5 at screening (within 5 days before study start)
- •3.Current IFD or prior history of IFD or patients who received systemic antifungal therapy for proven or probable IFD in the last 12 months.
- •4.Patients who received any systemic antifungal therapy for more than 72 hours immediately prior to first administration of study medication (except for patients in group P receiving posaconazole as fungal prophylaxis; see also inclusion criterion 8). Echinocandins and topical polyenes or nystatin are acceptable.
- •5.Concomitant exposure to phenobarbital and long acting barbiturates, triazolam, carbamazepine, phenytoin, pimozide, cisaprid, efavirenz, ritonavir, rifabutin, rifampicin, ergot alkaloids (ergotamine, dihydroergotamin), ibrutinib, idelalisib, vinca alkaloids, digoxin, dofetilide, quinidine, St. John´s wort, everolimus, sirolimus, astemizole, terfenadine, methadone, alfentanil, fentanyl and other structurally related opiates, warfarin (see also section 8.8 for details).
- •6.Documented prolongation of the QTc interval (>450 ms).
- •7.Concomitant medication that prolongs QT interval (except for cytostatic drugs used during chemotherapy, such as mitoxantrone).
- •8.Any other 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.History of convulsion.
- •10.Female patients only: Positive result of pregnancy test or breastfeeding.
- •11.Female patients of childbearing potential who do not practice sexual abstinence as their common way of life and confirm to stay sexually abstinent also during their participation in the study or who do not use or do not agree to use appropriate contraceptive methods (prior to and during the study, including 14 days after the last dose of study therapy) as defined in ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals (EMA/CPMP/ICH/286/1995). Hormonal contraception alone is not considered appropriate.
- •12.Known hypersensitivity to any component of the study medication.
- •13.A history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, cardiomyopathy, sinus bradycardia, symptomatic arrhythmias, family history of long QT Syndrome).
- •14.Patient has had acute hepatitis in the prior 6 months, chronic hepatitis, cirrhosis (any Child-Pugh class), acute hepatic failure, or acute decompensation of chronic hepatic failure
- •15.Presence of hepatic disease as indicated by aspartate aminotransferase (AST) or alanine transaminase (ALT)>3 × upper limit of normal (ULN) at Screening. Patients with AST and/or ALT >3 × ULN and <5 × ULN are eligible if these elevations are acute, not accompanied by a total bilirubin =2xULN and documented by the investigator as being directly related to an infectious process being treated. During the clinical study, the investigator is responsible for, without delay, determining whether the patient meets potential Hy’s law criteria (according to FDA [28]).
- •16.Patient has a total bilirubin >3 × ULN, unless isolated hyperbilirubinemia is directly related to an acute infection or due to known Gilbert’s disease.
- •17.Calculated creatinine clearance (CrCl) < 50 mL/minute.
- •18.Medical history of oliguria (< 20 mL/h) unresponsive to fluid challenge.
- •19.Suspected ot
研究者
相似试验
进行中（未招募）
1 期
An open-label clinical study to evaluate the safety and distribution in the body of a new drug (F901318), to be given as infusion, to prevent fungal infection in patients undergoing chemotherapy of leukemia.Infasive fungal disease in patients with acute myeloid leukemia under chemotherapyMedDRA version: 19.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-000919-33-DEF2G Limited10
已完成
2 期
To evaluate the safety and efficacy of Arnophyte Cream in subjects with HerpesCTRI/2018/01/011171Piramal Enterprises Limited40
已完成
2 期
To assess the safety and effectiveness of DPOR/JR2007 Tablets in Osteoarthritis of the Knee.CTRI/2017/07/009054Deltas Pharma45
进行中（未招募）
不适用
A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple MyelomaMedDRA version: 9.1Level: PTClassification code 10028228Term: Multiple myelomaMultiple MyelomaEUCTR2008-005112-41-DKSirtris Pharmaceuticals Inc.30
进行中（未招募）
不适用
A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple MyelomaMultiple MyelomaEUCTR2008-005112-41-GBSirtris Pharmaceuticals Inc.30