Phase II study of the histone-deacetylase inhibitor GIVINOSTAT (ITF2357) in combination with hydroxyurea in patients with JAK2V617F positive Polycythemia Vera non-responder to hydroxyurea monotherapy - GIVINOSTAT + Hydroxyurea in Polycythemia Vera

Active, not recruiting

• Conditions: Polycythemia Vera; MedDRA version: 14.1Level: HLTClassification code 10018847Term: Haematological disordersSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-010982-22-IT
• Lead Sponsor: ITALFARMACO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-13
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Written Informed Consent. Age ≥18 years. Confirmed diagnosis of Polycythemia Vera according to the revised WHO criteria. JAK2V617F positivity. Non-response to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months. ECOG performance status <3. Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential. Willingness and capability to comply with the requirements of the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Active bacterial or mycotic infection requiring antimicrobial treatment. Pregnancy or lactation. A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval > 450 ms, according to Bazett s correction formula). Use of concomitant medications that prolong the QT/QTc interval. Clinically significant cardiovascular disease including: - Uncontrolled hypertension, myocardial infarction, unstable angina within 6 months from study start; - New York Heart Association (NYHA) Grade II or greater congestive heart failure; - History of any cardiac arrhythmia requiring medication (irrespective of its severity); - A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). Positive blood test for HIV. Active HBV and/or HCV infection. Platelets count <100x109/L within 14 days before enrolment. Absolute neutrophil count <1.2x109/L within 14 days before enrolment. Serum creatinine >2xULN. Total serum bilirubin >1.5xULN. Serum AST/ALT > 3xULN. History of other diseases, metabolic dysfunctions, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications. Interferon alpha within 14 days before enrolment. Anagrelide within 7 days before enrolment. Any other investigational drug within 28 days before enrolment.

Study & Design

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