ACTRN12610000924055已完成1 期
A Phase Ib/II clinical evaluation of the safety and efficacy of combining panobinostat with 5-azacytidine in patients with high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukaemia (AML) that are unsuitable for standard induction chemotherapy.
The Alfred Hospital0 个研究点目标入组 40 人开始时间: 2010年10月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 55 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Age greater than 55 years and/or unsuitable for standard AML-type induction therapy
- •2. Provision of written informed consent
- •3. Patients with de novo (except Acute Promyelocytic Leukaemia) or secondary AML (including therapy-related) as defined by the World Health Organisation Classification (WHO) or poor risk myelodysplasia (International Prognostic Scoring System for MDS score Int-2 or High)
- •4. No previous chemotherapy other than hydroxyurea or thioguanaine which was ceased greater than 48 hours preceding commencement of study medication
- •5. Life expectancy of greater than 3 months in relation to diseases other then AML/MDS
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2
- •7. Electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (WNL) or easily correctable with supplements
- •8. Adequate hepatic function as defined by bilirubin = 2 times the upper limit of normal and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 times the upper limit of normal
- •9. Adequate renal function, with serum creatinine = 1.5 times the upper limit of normal
- •10. Patients with no uncontrolled active infection
- •11. Female patients who are amenorrhoeic for one year or have a negative pregnancy test within one day before commencing the trial. All patients of reproductive potential, and their partners, must agree to use at least two effective contraceptive methods throughout the study and for 30 days following the date of the last dose.
排除标准
- •1. Any serious medical or psychiatric conditions which the investigator feels may interfere with the patient’s ability to give informed consent or participate in the procedures or evaluations of the study
- •2. History of major non-compliance to medication
- •3. Evidence of central nervous system (CNS) leukemia
- •4. Impaired cardiac function or clinically significant cardiac disease as follows:
- •*Left ventricular ejection fraction (LVEF) <45% as determined by Multi Gated Acquisition scan (MUGA) scan or echocardiogram
- •*Complete left bundle branch block or right bundle branch block and left anterior hemiblock (bifascicular block)
- •* Obligate use of a cardiac pacemaker
- •* Congenital long QT syndrome or QTc > 480 msec on the screening ECG
- •* Clinically significant resting bradycardia (< 50 bpm)
- •* Angina pectoris or acute myocardial infarction 3 months prior to starting study drug
- •* Unstable angina, congestive cardiac failure (CCF) or acute myocardial infarction (AMI) within the last 6 months
- •5. Uncontrolled viral infection with known Human Immunodeficiency virus (HIV) or Hepatitis type B or C
- •6. Currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication
- •7. Any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardise compliance with the protocol
- •8. Female patients who are pregnant or breastfeeding and the lack of adequate contraception in females of childbearing potential, or their partners
- •9. Patients taking any concurrent medications which have a known risk of prolonging the QTc interval or inducing Torsades de Pointes tachycardia
研究者
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