NCT04610736已完成1 期
TEMOkids Study: A Population Pharmacokinetic, Acceptability and Safety Study for KIMOZO, a Paediatric Oral Suspension of Temozolomide
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 11
- 主要终点
- Population Phamacokinetic parameter: AUC24
研究概览
简要总结
Non-randomized, international, multi-centre, open-label, single arm study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.
详细描述
The TEMOkids study is an international open-label, non-randomized, prospective, single-arm phase 1 study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.
Patients will be subject to at least one 21 or 28-day treatment cycle involving administration of an oral suspension of temozolomide (KIMOZO) for five consecutive days followed by 16 or 23-days resting period, with determination of the PK parameters on the first treatment day.
Five (5) additional cycles will be allowed under compassionate use regimen. The compassionate use period could be extended at the discretion of the investigator and in agreement with the sponsor. Safety and activity data will be collected during the compassionate follow-up period.
The study will be held in multiple sites spread across Europe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients in need of temozolomide (all indications with 5-day treatment per 21- or 28-day cycle).
- •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:
- •haemoglobin ≥ 80 g/L (transfusion support authorized)
- •neutrophil count ≥ 1.0 x 10e9 cells/L
- •platelet count ≥ 100 x 10e9 cells/L (without transfusion support)
- •in case of bone marrow involvement: neutrophils ≥ 0.5 x 10e9 cells/L and platelets ≥75 x 10e9 cells/L
- •Adequate renal function:
- •Creatine clearance ≥ 60 mL/min.1.73m² according to the Schwartz formula [1] or its modified form [2]
- •Adequate hepatic function:
- •bilirubin ≤1.5 x ULN
- •AST and ALT ≤ 2.5 x ULN (AST, ALT 5xULN in case of liver metastases)
- •Lansky Score ≥ 70%
排除标准
- •Patients who are co-administrated at day one with sodium valproate as it decreases the clearance of temozolomide
- •Patients with (naso)gastric tube administration of temozolomide during first cycle of treatment.
- •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
研究组 & 干预措施
Single arm
Experimental
Temozolomide 40 mg/ml, Oral suspension
干预措施: Temozolomide Oral Suspension (Drug)
结局指标
主要结局
Population Phamacokinetic parameter: AUC24
时间窗: At Day 1 of treatment cycle 1 (each cycle is 21 or 28 days) with post-dose samples collected at about 0.15, 0.5, 1, 2.5, and 7 hours post dose
Estimated by a population analysis performed with NONMEM (7.4)
Population Phamacokinetic parameter: Cmax
时间窗: At Day 1 of treatment cycle 1 (each cycle is 21 or 28 days) with post-dose samples collected at about 0.15, 0.5, 1, 2.5, and 7 hours post dose
Estimated by a population analysis performed with NONMEM (7.4)
Population Phamacokinetic parameter: T1/2
时间窗: At Day 1 of treatment cycle 1 (each cycle is 21 or 28 days) with post-dose samples collected at about 0.15, 0.5, 1, 2.5, and 7 hours post dose
Estimated by a population analysis performed with NONMEM (7.4)
次要结局
- Acceptability of the oral suspension of temozolomide: score(At Day 1 and Day 5 of treatment cycle 1 (each cycle is 21 or 28 days))
- Incidence of treatment-emergent adverse events(Through study completion, an average of 6 months including compassionate use period)
- Activity of the oral suspension of temozolomide(At the end of each 21- or 28-day treatment cycle of the compassionate use period)
研究者
研究点 (11)
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