EUCTR2019-003733-41-IT进行中（未招募）1 期
Phase II study on Trabectedin in advanced rearranged Mesenchymal chondrosarcoma (MCS) - ISG-MCS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- All
入选标准
- •1.Age = 16 years old
- •2.Histological centrally confirmed diagnosis of skeletal or extra-skeletal MCS with the documented presence of HEY1-NCOA2 fusion (a paraffin embedded tumour block is required for centralized review)
- •3.Locally advanced disease (i.e. surgical resection of local disease unfeasible radically or unaccepted by the patient or amenable to become less demolitive or feasible or easier after cytoreduction) and/or metastatic disease
- •4.Measurable or evaluable disease with RECIST v1.1
- •5.Evidence of progression by RECIST v1.1 during the 6 months before study entry
- •6.Patients must be pre-treated with at least one prior chemotherapy treatment containing anthracyclines for the advanced phase of disease and with a maximum of 3 lines
- •7.Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
- •8.Adequate bone marrow function
- •9.Adequate organ function
- •10.Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study
- •11.Cardiac ejection fraction >=50% as measured by echocardiogram
- •12.No history of arterial and/or venous thromboembolic event within the previous 12 months
- •13.The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses.
- •14.Any other factors, that, at judgment of investigator, could affect the safety of the patients according to the available trabectedin safety data
- •Are the trial subjects under 18? yes
- •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 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Other primary malignancy with <5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse
- •2.Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
- •3.Previous radiotherapy to 25% of the bone marrow
- •4.Major surgery within 2 weeks prior to study entry
- •5.Participation in another clinical study with an investigational product, which last dose was taken less than 4 weeks prior to the start of the treatment.
- •6.Persistent toxicities (= NCI CTCAE v5.0 grade 2) with the exception of alopecia, caused by previous anticancer therapies.
- •7.Pregnancy or breast feeding
- •8.Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e. congestive heart failure, myocardial infarction within 6 months of study)
- •9.Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
- •10.Known brain metastasis
- •11.Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis)
- •12.Known diagnosis of human deficiency virus (HIV) infection
- •13.Active or chronic hepatitis B or C requiring treatment with antiviral therapy
- •14.Medical history of hemorrhage or a bleeding event = Grade 3 (NCI-CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment
- •15.Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results
- •16.Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
- •17.Expected non-compliance to medical regimens
研究者
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