EUCTR2009-010290-21-NL进行中（未招募）不适用
A phase Ib study of combination of temsirolimus (Torisel®) and pegylated liposomal doxorubicin (PLD, Doxil®/ Caelyx®) in advanced or recurrent breast, endometrial and ovarian cancer
niversity Medical Centre Nijmegen St Radboud0 个研究点开始时间: 2009年2月17日最近更新:
相关药物
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
- •Patients with proven advanced breast cancer, endometrial cancer or ovarian cancer, who are refractory to standard therapies or for whom no standard therapy exists.
- •Age = 18 years
- •Patients who have an ECOG status of 0 or 1
- •Patients who have a life expectancy of at least 12 weeks
- •Negative pregnancy test for female patients of childbearing potential
- •Signed informed consent
- •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
- •Adequate bone marrow: neutrophils = 1.5 x 109/L, platelets = 100 x 109/L and haemoglobin = 5.0 mmol/l
- •Adequate renal function: GFR = 60 ml/min
- •Adequate liver function: ALT and AST < 2.5 x ULN, total bilirubin = 1x ULN
- •Fasting level of total cholesterol of no more than 350 mg/dL (9.1 mmol/L) and triglyceride level of no more than 400 mg/L (4.5 mmol/L)
- •Left ventricular ejection fraction (LVEF) < 50%
- •History of serious cardiac disease
- •Active clinically serious bacterial, viral or fungal infections (> grade 2).
- •Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- •Clinically symptomatic brain or meningeal metastasis. Patients with seizure disorders requiring medication (such as steroids or antiepileptics). Concomitant treatment with strong CYP3A4 inductors (such as rifampicin, St. John´s Wort) or CYP3A4 inhibitors (such as ketoconazole, voriconazole, itraconazole, diltiazem, verapamil, erythromycin) within 2 weeks prior to start.
- •Moderate or weak CYP3A4 modifiers should be used concomitantly only after careful assessment of risk-benefit ratio. Concomitant use of carbamazepine, phenobarbital, phenytoin or chronic use of dexamethasone is not allowed. (Table 1)
- •Other concomitant anti-cancer therapy (except steroids)
- •Concomitant use of streptozocin, mercaptopurine.
- •Previous treatment with one of the study drugs.
- •Previous treatment with other mTOR inhibitors
- •Prior investigational therapy/agents within 4 weeks of start, in case of bevacizumab at least 60 days between bevacizumab discontinuation and first dosing of temsirolimus.
- •Surgical treatment or radiation therapy in the past 4 weeks. Palliative radiotherapy at focal sites on the extremities is allowed, also within 4 weeks before start
- •Unresolved toxicity CTC = grade 2 from previous anti-cancer therapy except alopecia.
- •Known or suspected allergy to any investigational agent or any agent given in association with this trial.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results
- •Any condition that is unstable or which could jeopardize the safety of patient and his compliance in the study.
- •Antracyclines: > 450 mg/m2 doxorubicin or and > 600 mg/m2 epirubicin
- •Medications known to have dysrhythmic potential is not permitted (ie, terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide)
- •Usage of coumarin-derivate anticoagulants. Low molecular weight heparin is permitted and advised.
研究者
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