A phase II, open-label, multicentre, pharmacokinetic, pharmacodynamic and safety study of anagrelide hydrochloride in young (18-50 years) and elderly (= 65 years) patients with essential thrombocythaemia.

Phase 1

• Conditions: Xagrid is an antineoplasic indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.

• Registration Number: EUCTR2004-004058-20-ES
• Lead Sponsor: Shire Pharmaceutical Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-18
• Study Completion: 2008-01-22
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•Young patients aged 18-50 years inclusive.
•Elderly patients aged 65 years and over.
•Patients must have a confirmed diagnosis of ET.
•Currently receiving anagrelide hydrochloride at a stable maintenance dose = 5 mg/day for at least 4 weeks.
•Body Mass Index (BMI) in the range 16-30 (calculated according to Quetlets method).
•Free of active infection.
•Adequate renal function (creatinine clearance in the range 97-137 ml/min (male) and 88-128 ml/min (female)).
•Adequate hepatic function (Aspartate amino transferase (AST) and bilirubin = 1.5 x upper limit of normal).
•Performance status 0 or 1 (World Health Organisation (WHO) criteria) with a life expectancy of > 4 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Diagnosis of any other myeloproliferative disorder.
•A resting ejection fraction below the limit of the laboratory normal.
•Current use of tobacco in any form (e.g. smoking or chewing).
•Standard blood donation (one pint or more) within 30 days prior to study initiation.
•Plasma donation within 7 days prior to study initiation.
•Abnormal diet or changes in eating habits (per investigator discretion) within 30 days prior to study initiation.
•Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study.
•Positive urine pregnancy test (for females of child bearing potential) at screening or baseline.
•Patients for whom use of another cytoreductive agent in addition to anagrelide is considered necessary for control of platelet count.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the pharmacokinetic (PK) profile of anagrelide and its active metabolite in young (18-50 years) versus elderly (= 65 years) essential thrombocythaemia (ET) patients.<br>;Secondary Objective: To evaluate the correlation, if any, between anagrelide daily dose, resultant anagrelide plasma concentrations and changes from baseline in platelet count in young (18-50 years) and elderly (=65 years) ET patients.<br><br>To evaluate the correlation, if any, between plasma concentration of anagrelide and its active metabolite and heart rate and blood pressure in young (18-50 years) and elderly (=65 years) ET patients.<br><br>To assess the safety and tolerability of anagrelide in young (18-50 years) and elderly (=65 years) ET patients.<br>;Primary end point(s): To compare the pharmacokinetic profile of anagrelide and its active metabolite in young (18-50 years) versus elderly (= 65 years) essential thrombocythaemia (ET) patients.