TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide - TEMOkids study

ORPHELIA Pharma0 个研究点目标入组 40 人开始时间: 2021年12月7日最近更新: 2023年7月18日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ORPHELIA Pharma
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

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

•Paediatric patients already receiving commercially available temozolomide-based treatment or naïve paediatric patients requiring temozolomide-based treatment as per investigator’s decision (all indications with 5-day treatment per 21- or 28-day cycle). Indications include those described in the Temodal SmPC (i.e. malignant glioma such as glioblastoma and anaplastic astrocytoma). For patients having no therapeutic alternatives, the IMP may be used in off-label indications in accordance with current treatment protocols recommended by European and International Medical Associations (e.g. SIOPEN, EPSSG, COG, European ITCC, SIOP,…). Such indications include but are not limited to primarily neuroblastoma, medulloblastoma and also rhabdomyosarcoma, or Ewing sarcoma
•Male and female patients aged 1 to less than 18 years
•Patients who have signed the informed consent or for which one, both parents or legal guardian (depending on local legislation) have signed the informed consent.
•Patients having records of coverage by a health insurance
•Life expectancy = 3 months
•Adequate haematological function:
•ohaemoglobin = 80 g/L (transfusion support authorized)
•oneutrophil count = 1.0 x 109 cells/L
•oplatelet count = 100 x 109 cells/L (without transfusion support)
•oin case of bone marrow involvement: neutrophils = 0.5 x 109 cells/L and platelets =75 x 109 cells/L
•Adequate renal function:
•oCreatine clearance = 60 mL/min.1.73m² according to the Schwartz formula [1] or its modified form [2]
•Adequate hepatic function:
•obilirubin =1.5 x ULN
•oAST and ALT = 2.5 x ULN (AST, ALT 5xULN in case of liver metastases)
•Lansky Score = 70%
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Patient treated with sodium valproate within two weeks prior to receiving Kimozo or patients who are co-administrated on day one of Kimozo administration with sodium valproate as it decreases the clearance of temozolomide.
•Patients with (naso)gastric tube administration of Kimozo .
•Patients already enrolled in studies investigating temozolomide or other investigational new drugs.
•A post-menarche female with a positive blood/urine pregnancy test at inclusion.
•Known contraindication or hypersensitivity to temozolomide or any chemically close substance.
•Persons who are living in a facility by order of a court or an administrative order.
•Patients infected by a SARS-CoV-2 variant.

研究者

发起方

ORPHELIA Pharma

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TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide

NL-OMON50808ORPHELIA Pharma1