NCT00106418已完成2 期
An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Androgen Independent Metastatic Prostate Cancer Patients With Rising PSA
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 35
- 主要终点
- Rate of objective disease control
研究概览
简要总结
The purpose of this study is to evaluate the activity of romidepsin (depsipeptide,FK228) in patients with metastatic prostate cancer who have developed a rising prostate specific antigen (PSA) while undergoing hormonal therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males ≥18 years;
- •Written informed consent/authorization;
- •Histological or cytological confirmation of metastatic prostate cancer with documented progression on hormonal therapy (objective progressive disease [PD], new bone lesions, or stable soft tissue or bone lesions with PSA increase);
- •Patients must have either measurable disease or bone metastasis. Patients with measurable disease are preferred;
- •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);
- •Serum testosterone level of <50 ng/mL in patients without surgical castration;
- •Patients must have serum potassium levels >4.0 mEq/L and serum magnesium levels >2.0 mg/dL.
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;
- •Concomitant use of warfarin (due to a potential drug-to-drug interaction with depsipeptide);
- •Major surgery within 2 weeks of study entry;
- •Prior treatment with chemotherapy;
- •Patients with known cardiac abnormalities such as:
- •Congenital long QT syndrome;
- •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 (see Appendix K). 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 (see Appendix J) definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI);
- •Patients with a history of sustained VT, 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 (see Appendix D) interval;
- •Concomitant use of medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4 (see Appendix E);
- •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 MRI scans are required only if brain metastasis is suspected clinically);
- •Inadequate bone marrow or other organ function, as evidenced by:
- •hemoglobin <9.0 g/dL (transfusions and/or erythropoietin are permitted);
- •absolute neutrophil count (ANC) ≤1.5 x 109 cells/L;
- •platelet count <100 x 109 cells/L;
- •total bilirubin >1.25 x upper limit of normal (ULN) for institution or >2.0 x ULN in the presence of demonstrable liver metastases;
- •aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN or >5.0 x ULN in the presence of demonstrable liver metastases;
- •serum creatinine >2 mg/dL;
- •Serum potassium levels < 4.0 mEq/L and serum magnesium levels <2.0 mg/dL;
- •Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively); or
- •Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
研究组 & 干预措施
Romidepsin
Experimental
13 mg/m^2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
干预措施: Romidepsin (Drug)
结局指标
主要结局
Rate of objective disease control
时间窗: Up to 6 months
Rate of objective disease control was defined as the proportion of patients with confirmed CR, PR, or SD for at least 6 months, as determined by the Response Evaluation Criteria for Solid Tumors (RECIST).
次要结局
未报告次要终点
研究者
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