A study to compare the pharmacokinetic (Pharmacokinetic is the effect the body has on the drugs) , pharmacodynamic (pharmacodynamic is the effect that drugs have on the body) and safety of Febuxostat between paediatric patients (=6<18 years of age) and adults.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Patients meeting ALL the following criteria will be eligible to enter the study:

1.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:
a.scheduled for first cytotoxic chemotherapy cycle, regardless of the line of treatment, because of hematologic malignancies, and
b.at intermediate or high risk for TLS, and
c.with serum uric acid (sUA) levels < 10 mg/dL at Visit 1 (Day 1), and
d.with no access to rasburicase;

2.Karnofsky performance status (KPS) of 100 to 30 for patients aged 16 years and older; Lansky Play performance status (LPS) of 100 to 30 for patients aged less than 16 years;

3.A female of childbearing potential may be enrolled providing she:
- has a negative pregnancy test during screening period and
- is routinely using a highly effective method of birth control resulting in a failure rate of less than 1% per year when used consistently and correctly (e.g. combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only containing hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or total sexual abstinence) until 6 months from the last study drug administration. ;

4.informed consent before any study-related procedures obtained by patient for adults or by patient’s parents (one or both according to local regulation) or legal guardian for children and adolescents;

5.life expectancy >1 month.

Are the trial subjects under 18? yes
Number of subjects for this age range: 96
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Patients will not be eligible to participate in the study if they meet ANY of the following exclusion criteria:

1.patients known to be hypersensitive to febuxostat or to any components of the formulation;
2.patients with hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactase malabsorption;
3.pregnant or breastfeeding women;
4.patients receiving febuxostat or any other urate-lowering therapy (e.g. allopurinol, rasburicase, probenecid) within 30 days prior to Visit 1 (Day 1);
5.patients receiving mercaptopurine and azathioprine within 14 days prior to Visit 1 (Day 1);
6.patients with severe renal insufficiency;
7.patients with severe hepatic insufficiency;
8.patients with diagnosis of Laboratory TLS (LTLS) or Clinical TLS (CTLS) at Visit 1 (Day 1).
9.Patients receiving any other investigational agent within 30 days prior to study Visit 1 (Day 1).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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