EUCTR2012-003499-37-IT进行中（未招募）不适用
ong-term study evaluating the effect of Givinostat in patients with JAK2V617F positive chronic myeloproliferative neoplasms.
ITALFARMACO0 个研究点开始时间: 2012年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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