EUCTR2006-004566-13-IT进行中（未招募）不适用
An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MERCK KGaA
- 入组人数
- 110
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
- •? Signed written informed consent
- •? ≥18 years of age
- •? Histologically documented SCLC
- •? Radiologically demonstrated extensive-stage
- •disease by thoracic and abdominal CT or MRI
- •scan prior to induction chemotherapy
- •? Received 4 cycles of platinum-based, first-line
- •chemotherapy (12-14 weeks) without thoracic
- •irradiation
- •? Experienced a response to platinum-based,
- •first-line chemotherapy (CR or PR according to
- •RECIST shown after second and fourth course
- •of induction chemotherapy compared to
- •findings prior to induction therapy)
- •? Confirmatory CT or MRI scan
- •? Negative CT scan of the head
- •? Be enrolled and begin treatment 3-5 weeks after
- •last infusion of platinum-based, first-line
- •chemotherapy
- •? Life expectancy ≥4 months
- •? ECOG performance status ≤2 at study entry
- •? No clinical history of significantly impaired
- •renal function or chronic kidney disease. Must
- •have an estimated glomerular filtration rate ≥50
- •mL/min determined by the Cockgraft-Gault
- •formula No significant haematologic abnormalities,
- •including white blood cell count ≥2.5 × 103/μl
- •(or total granulocytes ≥1 × 103/μl), absolute
- •lymphocyte count ≥0.5 × 103/μl, platelet count
- •≥100 000/μl, and haemoglobin level >5.5
- •? No significant hepatic abnormalities, including
- •alanine aminotransaminase and aspartate
- •aminotransaminase ≤2.5 × the upper limit of
- •normal (ULN), or ≤5 × ULN in case of liver
- •metastasis, and total bilirubin <1.5 × ULN
- •? No significant electrolyte abnormalities,
- •including serum sodium, potassium, and
- •phosphorus within normal limits
- •? Serologic testing within 4 weeks prior to
- •starting study treatment with negative results
- •for hepatitis C virus (HCV), human
- •immunodeficiency virus (HIV), and hepatitis B
- •virus (HBV) demonstrated by negative hepatitis
- •B core antibody (HBcAb) and hepatitis surface
- •antigen (HbsAg)
- •? Negative urine β-HCG pregnancy test and
- •willingness to use effective contraception for
- •both male and female subjects for the study
- •duration and 1 month thereafter if of
- •procreative potential; non-lactating females
- 另有 6 项未显示
排除标准
- •? Thoracic radiotherapy, surgery (excluding prior
- •diagnostic biopsy) or any investigational drug
- •in the 30 days before the start of treatment in
- •? ECG with evidence of active clinically
- •significant cardiac disease within 4 weeks prior
- •to starting study treatment and/or a cardiac
- •stress test with abnormal results in subjects who
- •have a history of signficant coronary heart
- •disease (MI, angina pectoris, or high risk of
- •uncontrolled arrhythmia)
- •? Uncontrolled CHF New York Heart
- •Association Grade 2-4 or echocardiogram with a left ventricular ejection fraction <45%, or
- •other signs of active clinically significant
- •cardiovascular disease
- •? History of repeated and clinically relevant
- •episodes of syncope or other paroxysmal,
- •ventricular, or other clinically significant
- •arrhythmias unless controlled by an automatic
- •internal cardiac defibrillator
- •? Uncontrolled hypertension (systolic blood
- •pressure ≥180 mmHg or diastolic blood
- •pressure ≥100 mmHg) or hypotension (systolic
- •blood pressure ≤80 mmHg requiring therapy
- •beyond 24 hours)
- •? Evidence of active brain metastases
- •? No past history of neoplasm other than lung
- •carcinoma, except for curatively treated nonmelanoma
- •skin cancer, in situ carcinoma of the
- •cervix or other cancer curatively treated and
- •with no evidence of disease for at least 5 years.
- •? Presence of medically significant third space
- •fluids such as pleural or pericardial effusions or
- •ascites requiring repetitive paracentesis, or
- •oedema ≥Grade 2 according to the National
- •Cancer Institute Common Terminology Criteria
- •for Adverse Events (NCI CTCAE) Version 3.0
- •? Previous diagnosis of autoimmune disease
- •involving major organ system or requirement
- •for immunosuppressive therapy
- •? History of inflammatory bowel disease or
- •history of acute or chronic bowel ischemia
- •? Significant active infection
- •? Legal incapacity or limited legal capacity that
- •would interfer with informed consent or impair
- •participation in the study
- •? Known hypersensitivity to Tween-80TM, human
- •immunoglobulin, CTX, or any of the
- •components of study treatments
研究者
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