EUCTR2008-002309-38-HU进行中（未招募）不适用
A phase III, randomized, double-blind, placebo-controlled multi-center study of ASA404 in combination with docetaxel in second-line treatment of patients with advanced or metastatic (stage IIIb/IV) non-small cell lung cancer (NSCLC). - ATTRACT-2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
- •1. Histologically confirmed non-small cell carcinoma of the lung of all histologies.
- •2. Patients who have progressed while on or following a first-line chemotherapy regimen for Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease. Patients who have received bevacizumab and/or EGFR inhibitors in first-line will be eligible
- •3. Age = 18 years old
- •4. WHO Performance Status of 0-2
- •5. Measurable or non-measurable disease per RECIST criteria
- •6. Laboratory values within the range, as defined below, within 2 weeks of randomization:
- •Absolute neutrophils count (ANC) = 2.0 x 109/L
- •Platelets = 100 x109/L
- •Hemoglobin = 10 g/dL
- •Serum creatinine = 1.5 x ULN (= 120 micro mol/L)
- •Serum bilirubin = 1.5 x ULN (= 25 micro mol/L)
- •Alkaline phosphatase = 2.5 x ULN
- •Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 x ULN (= 5 x ULN if liver metastases)
- •International Normalized Ratio (INR) or Prothrombin Time (PT) = 1.5 x ULN
- •Electrolyte values (sodium, potassium, calcium, magnesium) within =1 x LLN and = 1 x ULN. Patients with corrected electrolyte values are eligible
- •Females of child-bearing potential must have negative serum pregnancy test (confirmation of negative urine pregnancy test within 72 hours prior to initial dosing)
- •7. Life expectancy = 12 weeks
- •8. Written informed consent obtained according to local guidelines
- •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
- •1. Patients having CNS metastases
- •2. Patients with a history of another primary malignancy = 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ.
- •3. Radiotherapy = 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
- •4. Major surgery = 4 weeks prior to randomization (major surgery is defined by the use of general anesthesia). Endoscopic examinations with diagnostic intent are not considered major surgery. Minor surgery = 2 weeks prior to randomization. Insertion
- •of a vascular access device is allowed. Insertion of a vascular access device is not considered major or minor surgery. Patients must have recovered from all surgery-related complications.
- •5. Treatment with first-line chemotherapy regimen = 3 weeks prior to randomization (= 6 weeks for bevacizumab, mitomycin and nitrosoureas)
- •6. Concurrent use of other investigational agents and patients who have received investigational agents = 4 weeks prior to randomization
- •7. Prior treatment with docetaxel for NSCLC in the first-line setting
- •8. Prior treatment with VDAs or tumor - VDAs for NSCLC in the firstline setting
- •9. Pleural effusion that causes = CTC grade 2 dyspnea
- •10. Patients with systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg while on medication for hypertension
- •11. Patients with recent hemoptysis associated with NSCLC (> 1 teaspoon in a single episode within 4 weeks)
- •12. Patients with any one of the following:
- •Patients with long QT syndrome
- •Patients with a Baseline 12-lead ECG QTc of > 450 msec per central evaluation
- •Congestive heart failure (NY Heart Association class III or IV)
- •Patients with a myocardial infarction within 12 months of study entry or with implanted cardiac pacemaker
- •Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
- •History of labile hypertension or poor compliance with antihypertensive regimen
- •History of a sustained ventricular tachycardia
- •Any history of ventricular fibrillation or Torsades de Pointes
- •Right bundle branch block and left anterior hemiblock (bifasicular block)
- •Bradycardia defined as heart rate < 50 beats per minute
- •13. Concomitant use of drugs with a risk of causing Torsades de Pointes
- •14. Known allergy or hypersensitivity to docetaxel or drugs formulated with polysorbate 80
- •15. Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
- •16. Pregnant or breast feeding females
- •17. Women of child bearing potential or sexually active males,
- •unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment.
- •18. Concurrent severe and/or uncontrolled medical disease
- •19. Significant neurologic or psychiatric disorder which could compromise participation in the study
- •20. Patient unwilling or unable to comply with the protocol
研究者
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