ong-term study evaluating the effect of Givinostat in cMPN.

• Conditions: Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; Chronic myeloproliferative neoplasms (cMPN).; MedDRA version: 14.1Level: HLTClassification code 10028578Term: Myeloproliferative disorders (excl leukaemias)System Organ Class: 100000004851

• Registration Number: EUCTR2012-003499-37-IT
• Lead Sponsor: ITALFARMACO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-19
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients must have completed Givinostat treatment on at least one core study in cMPN (i.e. Study DSC/07/2357/28, Study DSC/08/2357/38 and/or any further core protocols in cMPN), or Patients must be participating in a compassionate use program with Givinostat; 2. Patients must be able to provide informed consent and be willing to sign an informed consent form; 3. Adult patients (age = 18 years) of both genders with established diagnosis of JAK2 V617F positive cMPN according to the revised WHO criteria; 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status < 3; 5. Acceptable organ function within 7 days of initiating study drug; 6. Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential; 7. 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 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. Active bacterial or mycotic infection requiring antimicrobial treatment; 2. Pregnancy or nursing; 3. A clinically significant QTc prolongation at baseline (e.g. repeated demonstration of a QTc interval > 450 ms); 4. Use of concomitant medications known to prolong the QTc interval; 5. 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); (for a complete list refer to the protocol)

Study & Design

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