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 1 人开始时间: 待定最近更新: 2024年4月9日

试验速览

阶段: 2 期
状态: 已完成
发起方: ORPHELIA Pharma
入组人数: 1

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

入排标准

年龄范围: 0 至 17（—）

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
•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
•Patients having records of coverage by a health insurance
•Life expectancy >= 3 months
•Adequate haematological function:
•o haemoglobin >= 80 g/L (transfusion support authorized)
•o neutrophil count >= 1.0 x 109 cells/L
•o platelet count >= 100 x 109 cells/L (without transfusion support)
•o in case of bone marrow involvement: neutrophils >= 0.5 x 109 cells/L and
•platelets >=75 x 109 cells/L
•Adequate renal function:
•o Creatine clearance >= 60 mL/min.1.73m² according to the Schwartz formula [1]
•or its modified form
•Adequate hepatic function:
•o bilirubin <=1.5 x ULN
•o AST and ALT <= 2.5 x ULN (AST, ALT 5xULN in case of liver metastases)
•Lansky Score >= 70%

排除标准

•Patient treated with sodium valproate within two weeks prior to receiving
•Kimozo or patients who are coadministrated 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
•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
•Patients infected by a SARS-CoV-2 variant.

研究者

发起方

ORPHELIA Pharma

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