NCT00412880已完成2 期
An Open-label Phase II Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of 200 mg i.v. BI 2536 Administered Every 21 Days in Patients With Sensitive Relapse Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 10
- 主要终点
- Number of Participants With Objective Tumor Response
研究概览
简要总结
Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.
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 histologically or cytologically confirmed, -sensitive-relapse- SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.
- •Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater.
- •Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines.
排除标准
- •More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology.
- •Symptomatic brain metastases or leptomeningeal disease
- •Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer)
- •Absolute neutrophil count (ANC) <1,500/µl, platelet count <100,000/µl, or hemoglobin <9 mg/dl
- •Total bilirubin >1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine >2.0 mg/dl (>176 µmol/L, SI Unit equivalent)
- •Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug
- •Radiation therapy within the past 2 weeks prior to or during treatment with the trial drug
- •Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection
- •Known or suspected active drug or alcohol abuse
- •Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug
- •Patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (Coumadin ®)
- •Patients with neuropathy (sensory or motor) CTCAE 3
研究组 & 干预措施
BI 2536
Experimental
Total Patients
干预措施: BI 2536 (Drug)
结局指标
主要结局
Number of Participants With Objective Tumor Response
时间窗: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Objective tumor response by investigator was assessed for patients who completed at least two courses of BI 2536 treatment. Tumor images from CT (computed tomography) scan and MRI (magnetic resonance imaging) were evaluated using Response evaluation criteria in solid tumors (RECIST) criteria to determine best tumor response. Objective response (OR) was defined as either: complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).
次要结局
- Occurrence and Intensity of Adverse Events Graded According to CTCAE(From the start of treatment till the last infusion + 21 days, up to 36 weeks.)
- Overall Survival(From the start of treatment till death or discontinuation, up to 36 weeks.)
- Progression Free Survival (PFS)(Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.)
- Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures(From the start of treatment till the last treatment + 21 days, up to 36 weeks.)
- Duration of Overall Response(Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.)
- Number of Participants With Dose Limiting Toxicity(From the start of treatment till the last treatment + 21 days, up to 36 weeks.)
研究者
研究点 (10)
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