EUCTR2011-001518-33-GB进行中（未招募）1 期
A signal seeking window trial of AZD8931 in patients with resectable non-small cell lung cancer - Window Trial of AZD8931 in resectable non-small cell lung cancer
niversity Hospital of South Manchester NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2012年7月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
入选标准
- •Age 18 years or older.
- •Histologically confirmed NSCLC
- •Operable disease as determined by local staging investigations, including CT scan of thorax and abdomen, FDG-PET scan and mediastinoscopy where indicated as a standard of care.
- •Availability of surplus diagnostic biopsy tissue
- •WHO performance status 0 or 1
- •Haematology (These measurements must be performed within two weeks prior to the patient going on study):
- •Haemoglobin (Hb) > 9 g/dl
- •Neutrophils > 1.5 x 10 9/L
- •Platelets > 100 x 109/L
- •Partial thromboplastin time (PTT) and Prothrombin time (PT) < 1.5 x ULN
- •Hepatic function
- •Serum bilirubin < 1.5 x upper limit of normal (ULN)
- •Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 2.5 X ULN
- •Adequate renal function (calculated clearance > 50 ml/min as per calculated Cockcroft formula
- •Ability to give written informed consent according to ICH/GCP, and national/local regulations.
- •Ability to co-operate with study treatment and follow up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Pregnancy. Only women of NONE child bearing potential may enter the study. Women must be permanently or surgically sterilized or postmenopausal* (see protocol for definitions).
- •Previous systemic treatment, radiotherapy or surgery for current lung cancer
- •Serious pre-existing medical co-morbidities, e.g. uncontrolled diabetes mellitus, uncontrolled respiratory or cardiac disease or ongoing or active infection (including HIV)
- •Psychiatric illness and/or social situation that would preclude study compliance
- •Prior (within the past 2 years) or concurrent malignancy (except adequately treated non-melanomatous skin cancer and resected cervical carcinoma in situ)
- •Baseline resting ECG with measurable QTc interval >480msec.
- •Echocardiogram confirming inadequate left ventricular function, LV ejection fraction<45%.
- •Known uncontrolled or symptomatic angina, arrhythmias or congestive heart failure, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic >180 mmHg or diastolic >100 mmHg), significant valvular disease or history of high risk dysrrhythmia (such as ventricular fibrillation or ventricular tachycardia [includes ventricular triplets])
- •Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- •Significantly impaired visual acuity
- •Medication that induces or inhibits CYP3A4 or reduces gastric acid production unless medically indicated
研究者
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