NCT01279967Unknown2 期
A Randomized Stratified Multicentre Phase II Clinical Trial of Single Agent ADI-PEG 20TM (Pegylated Arginine Deiminase) in Patients With Malignant Pleural Mesothelioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- progression-free survival
研究概览
简要总结
To examine whether the arginine depleting drug, ADI-PEG 20, might be effective as a targeted therapy in patients with ASS-negative malignant pleural mesothelioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Males and Females aged 18 years and older. (There is no upper age limit)
- •Histopathological evidence of ASS-negative MPM. All biopsies will be reviewed for ASS expression using immunohistochemistry. Central lab confirmation is required before randomization
- •Performance status ECOG ≤
- •Life expectancy should be greater than 3 months
- •Chemo-naive patients OR, Patients who have been previously treated with platinum-based combination chemotherapy with progressive disease at entry. In the event of a baseline diagnostic ASS-positive test, a repeat biopsy confirming loss of ASS expression will be required post platinum-based combination chemotherapy, with at least a 4 week interval from the last treatment episode.
- •CT evaluable disease by modified RECIST criteria
- •Adequate bone marrow function, or supported through treatment:
- •Haemoglobin 10g/dl or greater.
- •White cell count 2 x 109/L or greater, neutrophil count 1.5 x 109/L or greater
- •Platelets 75 x 109 /L or greater.
- •Adequate hepatic function (AST and ALT < 3 x upper limit of normal; bilirubin < 1.5 x upper limit of normal)
- •Creatinine clearance >30ml/min
- •Able to give written informed consent to participate
排除标准
- •Participation in another clinical trial using an investigational agent
- •Patients with surgically resectable disease
- •Recurrent pleural effusion (not pleurodesed)
- •Receipt of extensive radiation (hemi-thorax) therapy within 6 weeks before enrollment. Radiation to chest port sites following thoracotomy is permitted
- •A history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years, or the tumour was a non-melanoma skin tumour or in-situ cervix carcinoma
- •Symptomatic or known brain or leptomeningeal metastases
- •Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment
- •New York Heart Association (NYHA) Class III or IV heart failure (Attachment 10, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
- •Serious medical (e.g. uncontrolled diabetes, hepatic disease, infection, uncontrolled gout) or psychiatric illness likely to interfere with participation in this clinical study
- •History of seizures
- •Patients of child-bearing age must not become pregnant. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. All patients enrolled on the study must agree to use acceptable birth control measures whilst on the study; using both barrier and hormonal methods. Patients that are surgically sterile are also eligible to participate in this study
- •Females must not be breastfeeding
- •Prior exposure to ADI-PEG 20
- •Preplanned surgery or procedures that would interfere with the study protocol
- •Allergy to pegylated products
- •Exposure to another investigational drug within 4 weeks prior to start of study treatment
研究组 & 干预措施
B
Experimental
Arm B is the treatment arm with best supportive care plus ADI-PEG20.
干预措施: ADI-PEG 20 (Drug)
结局指标
主要结局
progression-free survival
时间窗: 18 months
次要结局
- overall survival(18 months)
- time to progression(18 months)
- safety (adverse events)(18 months)
- response rate(18 months)
研究者
研究点 (7)
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