EUCTR2005-001576-13-GB进行中（未招募）1 期
An exploratory Phase II, multicenter, open-label trial evaluating the activity and tolerability of of FK228 in androgen independent metastatic prostate cancer patients with a rising PSA. - Depsipeptide in prostate cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
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
入选标准
- •Males aged >/=18 years;
- •Histologically or cytologically confirmed metastatic prostate cancer with documented prpgression on hormonal therapy (objective progressive disease [PD], new bone lesions, or stable soft tissue or bone lesions with PSA increase);
- •Rising PSA, with a minimum study entry PSA of >/=5 ng/mL;
- •Karnofsky performance status of >/=80%;
- •Life expectancy of >/=12 weeks;
- •For patients treated with anti-androgens, elevation of PSA must be demonstrated after cessation of anti-androgen treatment;
- •Three lines of hormonal therapy are permitted prior to study entry (anti-androgen withdrawal is not considered as a second hormonal treatment); and
- •Serum testosterone level of <50 ng/mL in patients without surgical castration
- •Written informed consent to participate in the study.
- •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
排除标准
- •Concomitant use of any anti-cancer therapy, except for continued use of luteinizing hormone-releasing hormone (LHRH) agonists or antiandrogens, or bisphosphonates or steroids initiated at least 4 weeks prior to study entry;
- •Concomitant use of any investigational agent, including PC-SPES;
- •Use of any investigational agent within 4 weeks of study entry;
- •Major surgery within 2 weeks of study entry;
- •Prior treatment with chemotherapy;
- •Patients with known cardiac abnormalities such as:
- •Congenital long QT syndrome
- •Corrected QT (QTc) interval >480 milliseconds
- •Patients who have had a myocardial infarction within 12 months of study entry;
- •Patients who have a history of coronary artery disease (CAD) e.g., angina Canadian Class II-IV . In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present.
- •Patients with an ECG recorded at screening showing evidence of cardiac ischemia (ST depression of =2 mm). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present.
- •Patients with congestive heart failure that meets NYHA Class II to IV definitions and/or ejection fraction <40% by multiple-gated acquisition (MUGA) scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI)
- •Patients with a history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
- •Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above)
- •Patients with uncontrolled hypertension i.e., =160/95
- •Patients with any cardiac arrhythmia requiring anti-arrhythmic medication
- •Concomitant use of medications which may cause a prolongation of QT/QTc interval;
- •Concomitant use of medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4
- •Concomitant use of drugs which may cause a prolongation of the QTc
- •Clinically significant active infection;
- •Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
- •Previous extensive radiotherapy involving >30% of bone marrow (e.g., whole of pelvis, half of spine);
- •Clinical or radiological imaging evidence of brain metastasis (computed tomography [CT] or magnetic resonance imaging [MRI] scans are required only if brain metastasis is suspected clinically);
- •Inadequate bone marrow or other organ function
研究者
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