EUCTR2005-004420-39-NL进行中（未招募）不适用
An Open Label Phase II Multicentre Clinical Trial of Single Agent VELCADE (Bortezomib) in Patients with Malignant Pleural Mesothelioma - Phase II Velcade Mesothelioma trial
All-Ireland Co-operative Oncology Research Group (ICORG)0 个研究点目标入组 111 人开始时间: 2006年8月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 111
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) Histopathological evidence of MPM
- •2) Performance status ECOG 0-2.
- •3) Adequate haematological status:
- •3a) Haemoglobin 10g/dl or greater.
- •3b) White cell count 1 x 10(9)/L or greater, neutrophil count 1.5 x 10(9)/L or greater.
- •4) Platelets 100 x 10(9) /L or greater.
- •5) Adequate hepatic function (AST and ALT < 3 x upper limit of normal).
- •6) Willing to give written informed consent to participate. Translational research will be dealt with by a separate informed consent form.
- •7) Where possible, pleural effusions should be drained before treatment. For uncontrollable pleural effusions (recurrent despite regular drainage), talc or tetracycline pleurodesis may be offered as per standard practice.
- •8) Male subject agrees to use an acceptable method of birth control for the duration of the study and contraception must be used by women of child bearing potential.
- •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) Any of the inclusion criteria are not met
- •2) Enrollment in another clinical trial.
- •3) The patient has 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.
- •4) Symptomatic or known Brain or leptomeningeal metastases.
- •5) 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.
- •6) Patients may not have received more than 1 prior line of anti-neoplastic treatment for MPM.
- •7) Prior exposure to VELCADE.
- •8) Pregnant or breastfeeding.
- •9) Neuropathy Grade 2.
- •10) Preplanned surgery or procedures that would interfere with the conduct of the study.
- •11) Receipt of extensive radiation therapy, systemic chemotherapy, or other anti-neoplastic therapy within 4 weeks before enrollment.
- •12) Serious medical (e.g. uncontrolled diabetes, hepatic disease, infection,) or psychiatric illness likely to interfere with participation in this clinical study.
- •13) Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. Concurrent participation in any treatment studies is not allowed.
研究者
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