EUCTR2012-003672-39-NL进行中（未招募）1 期
Phase II trial of cabazitaxel in metastatic or inoperable locally advanced dedifferentiated liposarcoma.
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 50 人开始时间: 2015年1月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Registration step 1:
- •- Local diagnosis of DD liposarcoma
- •-Mandatory availability for shipment of formalin-fixed, paraffin
- •embedded, tumor-containing tissue blocks from primary tumor and/or
- •metastatic site.
- •-If a block cannot be provided, the following should be submitted:
- •? For cases that will be reviewed in UK : 4 x 1 micron sections on coated
- •slides, one thin H&E stained section and 20 unstained sections of usual
- •thickness (2-4 micron) on coated slides.
- •? For cases that will be reviewed in France: 3 x 4 micron sections on
- •unstained (coated) slides for FISH and 15 unstained slides (4 micron)
- •for immunohistochemistry.
- •-Before patient registration step 1, written informed consent for central
- •collection of tissue block or slides and any other trial-specific procedures
- •must be obtained from the patient according to ICH/GCP, and
- •national/local regulations, allowing for collection, storage and analysis
- •of tissue and screening procedures.
- •Registration step 2:
- •-Central pathology confirmation of DD liposarcoma within 3 weeks after
- •registration step 1.
- •-Radiological or histological diagnosis of inoperable locally advanced or
- •metastatic disease, with evidence of disease progression within the past
- •6 months prior to registration step 2.
- •-Clinically and/or radiographically documented measurable disease
- •within 28 days prior to registration step 2.
- •-One previous chemotherapy regimen for locally advanced or metastatic
- •DD liposarcoma (this could include pre-operative chemotherapy for
- •primary disease).
- •-Not more than 1 prior molecularly targeted therapy (e.g. CDK4
- •inhibitor). Any such prior therapy must be completed at least 2-4 weeks
- •prior to registration step 2.
- •-Age 18-75 years old
- •-WHO performance status 0-1
- •-Adequate haematological, renal and hepatic function
- •-Estimated life expectancy > 3 months
- •-All related adverse events from previous therapies must have recovered
- •to = Grade 1
- •-Women of child bearing potential must have a negative serum
- •pregnancy test within 72 hours prior to the first dose of study treatment.
- •-Patients of childbearing / reproductive potential should use adequate
- •birth control measures, as defined by the investigator.
- •-It is recommended that patients do not attempt to become pregnant or
- •to breast feed after exposure to these chemotherapy agents, as there is
- •no available data on safety. If despite this advice patients wish to do so,
- •then it is recommended a minimum of 6 months should first be allowed
- •to elapse from the last received dose.
- •-Men should use reliable contraception throughout treatment and are
- •recommended to continue this for up to 6 months after the last dose of
- •cabazitaxel.
- •Are the trial subjects under 18? no
- 另有 5 项未显示
排除标准
- •Registration step 2
- •-inflammation of the urinary bladder (cystitis)
- •-symptomatic CNS metastases
- •-invasive malignancy within 5 years, with the exception of nonmelanoma
- •skin cancer, localized cervical cancer, localized and
- •presumably cured prostate cancer or adequately treated basal or
- •squamous cell skin carcinoma
- •-significant cardiac disease: i.e. active ischaemic heart disease or cardiac
- •-uncontrolled severe illness or medical condition (including acute
- •infection, uncontrolled diabetes), other than the DD liposarcoma
- •-concurrent or planned treatment with strong inhibitors or inducers of
- •cytochrome P450 3A4/5 (a one week wash-out period is necessary for
- •patients who are already on these treatments)
- •-known hypersensitivity to taxanes or their excipients (cabazitaxel, like
- •docetaxel, is solubilized in polysorbate 80 and ethanol)
- •-any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow-up
- •schedule; those conditions should be discussed with the patient before
- •registration in the trial.
研究者
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