NCT00982631Unknown1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MTD, pharmacokinetic parameters
研究概览
简要总结
A study to examine the combination of temsirolimus and Caelyx® (chemotherapeutic) in advanced or recurrent breast, endometrial and ovarian cancer.
详细描述
To assess the maximum tolerated dose (MTD) and recommended phase II dose of the combination of temsirolimus and Caelyx® in patients with advanced or therapy refractory breast cancer, endometrial cancer, or ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
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
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
研究组 & 干预措施
temsirolimus/PLD
Experimental
temsirolimus (Torisel) with pegylated liposomal doxorubicin (PLD,Doxil,Caelyx);a dose escalating study in a 3+3 design
干预措施: Temsirolimus/PLD (Drug)
结局指标
主要结局
MTD, pharmacokinetic parameters
时间窗: 2 years
次要结局
- Effectiveness: objective response rate, time to progression(2 years)
研究者
研究点 (1)
Loading locations...
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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 cancerEUCTR2009-010290-21-NLniversity Medical Centre Nijmegen St Radboud
招募中
不适用
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