Open Label, Multi-centre, Parallel Group Study to Compare the Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of Febuxostat Between Pediatric Patients (≥6<18 Years of Age) and Adults
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 17
- 主要终点
- Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/F)
研究概览
简要总结
The purpose of this study is to compare the exposure of febuxostat in pediatric patients (≥6<18 years of age) and in adults suffering from hematological malignancies at intermediate to high risk of TLS and to compare the effect in terms of serum uric acid levels.
详细描述
In the FLORET study it is planned to enroll 3 groups of patients in order to receive oral administration (film-coated tablets) of two different dose levels of febuxostat: children (from 6 to less than 12 years of age) will receive two different dose levels respectively; adolescents (from 12 to less than 18 years of age) will receive 80 and 120 mg/day respectively and adults (equal or major than 18 years of age) will receive 120 mg/day. The two dose levels for children and adolescents groups were to be sequentially administered, whereas the groups that will receive the first dose levels will simultaneously start the treatment at the study beginning. The individual treatment duration will be of 7 to 9 days, according to chemotherapy duration, as per Investigator's judgement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female children of 6 to less than 12 years of age, adolescents of 12 to less than 18 years of age and adults from 18 years:
- •scheduled for first cytotoxic chemotherapy cycle because of hematologic malignancies
- •and at intermediate or high risk of TLS
- •and with no access to rasburicase
排除标准
- •patients with contraindications as per febuxostat summary of product characteristics
- •patients with severe renal insufficiency
- •patients with severe hepatic insufficiency
- •patients with diagnosis of Laboratory TLS (LTLS) or Clinical TLS (CTLS)
研究组 & 干预措施
Cohort 1
Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days
干预措施: Febuxostat (Drug)
Cohort 2
Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days
干预措施: Febuxostat (Drug)
Cohort 3
Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)
干预措施: Febuxostat (Drug)
Cohort 4
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
干预措施: Febuxostat (Drug)
Adults
Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg)
干预措施: Febuxostat (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/F)
时间窗: 7 days
Apparent clearance of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
PK Parameter: Absorption Rate Constant (Ka)
时间窗: 7 days
Absorption rate constant of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
PK Parameter: Area Under Curve (AUC)
时间窗: 7 days
AUC of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
PK Parameter: Maximum Plasma Concentration (Cmax)
时间窗: 7 days
Maximum plasma concentration of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
PK Parameter: Apparent Volume of Distribution (Vd/F)
时间窗: 7 days
Apparent volume of distribution of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
PK Parameter: Tmax
时间窗: 7 days
Time to Cmax from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
次要结局
- Assessment of Clinical Tumor Lysis Syndrome (CTLS)(7 days)
- Assessment of Treatment Emergent Signs and Symptoms (TESS)(Estimated maximum time frame: 27 days)
- Pharmacodynamic (PD) Parameter: Area Under the Curve of Serum Uric Acid (sUA)(8 days)
- Assessment of Laboratory Tumor Lysis Syndrome (LTLS)(7 days)
- Assessment of Participants Affected by Treatment Emergent Signs and Symptoms (TESS)(Estimated maximum time frame: 27 days)
- Performance Status (PS) Evaluation(Estimated maximum time frame: 27 days)