EUCTR2008-002309-38-GB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 locally 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
- •6. Central 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
- •Serum bilirubin = 1.5 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). Any female presenting with a positive or borderline pregnancy test may undergo a gynecological exam and ultrasound to rule out pregnancy and if found to be negative
- •may be included in the trial.
- •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 concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer.
- •3. Radiotherapy = 2 weeks prior to randomization. Patients must have recovered from all acute radiotherapy-related toxicities.
- •4. Major surgery must be completed 4 weeks prior to starting study treatment. Major surgery is defined at the investigator’s discretion. Insertion of a vascular access device is not considered major or minor surgery. Patients must have recovered from all acute major surgery-related complications.
- •5. Treatment with all prior anticancer therapies= 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 in the locally advanced or metastatic first-line setting
- •8. Prior treatment with VDAs or tumor - VDAs
- •9. Any medical condition resulting in = 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 QTcF of > 450 msec for women using the Fridericia [QTcF formula] measurement determined per central ECG evaluation report
- •Congestive heart failure (NY Heart Association class III or IV)
- •Patients with a myocardial infarction within 12 months of starting study treatment or with implanted cardiac pacemaker
- •Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
- •History of poorly-controlled labile hypertension or poor compliance with antihypertensive regimen
- •History of a sustained ventricular tachycardia
- •Presence of atrial tachyarrhythmia (e.g. atrial fibrillation, atrial flutter, multifocal atrial tachycarida, supraventricular tachycardia) in not effectively rate-controlled
- •Any history of ventricular fibrillation or Torsades de Pointes (TdP)
- •Right bundle branch block (RBBB) and either left anterior hemiblock or left posterior hemiblock (bifasicular block)
- •Bradycardia defined as heart rate < 50 beats per minute
- •13. Patients who are currently receiving treatment with any medications that have the potential to prolong QT interval or are known to have Concomitant use of drugs with a risk of causing Torsades de Pointes (See Section 6.8.5.1Table 6-4 and Appendix 2) which cannot be either safely discontinued or switched to a different medication prior to starting study drug administration must be discussed with and approved by the Novartis Global Clinical team prior to randomization
- •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.
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