NCT04305548招募中2 期
Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Overall tumour Response Rate, according to RECIST v 1.
研究概览
简要总结
Prospective, uncontrolled, investigator-initiated, phase II clinical study to explore the activity of trabectedin in a population of patients aged ≥16 years with progressive, advanced (locally advanced or metastatic)
详细描述
Prospective, uncontrolled, multicenter, Italian, investigator-initiated, phase II clinical study to explore the activity of trabectedin in a population of patients aged ≥16 years with progressive, advanced (locally advanced or metastatic), HEY1-NCOA2 positive MCS) , pre-treated with anthracycline-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 16 years old
- •Histological centrally confirmed diagnosis of skeletal or extra-skeletal MCS with the documented presence of HEY1-NCOA2 fusion
- •Locally advanced disease and/or metastatic disease
- •Measurable or evaluable disease with RECIST v1.1
- •Evidence of progression by RECIST v1.1 during the 6 months before study entry
- •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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- •Adequate bone marrow function
- •Adequate organ function
- •Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy.
- •Cardiac ejection fraction ≥50% as measured by echocardiogram
- •No history of arterial and/or venous thromboembolic event within the previous 12 months
- •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.
- •Any other factors, that, at judgment of investigator, could affect the safety of the patients according to the available trabectedin safety data
排除标准
- •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
- •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
- •Previous radiotherapy to 25% of the bone marrow
- •Major surgery within 2 weeks prior to study entry
- •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.
- •Persistent toxicities (≥ grade 2) with the exception of alopecia, caused by previous anticancer therapies.
- •Pregnancy or breast feeding
- •Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
- •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
- •Known brain metastasis
- •Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis)
- •Known diagnosis oh human deficiency virus (HIV) infection
- •Active or chronic hepatitis B or C requiring treatment with antiviral therapy
- •Medical history of hemorrhage or a bleeding event ≥ Grade 3 within 4 weeks prior to the initiation of study treatment
- •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
- •Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
- •Expected non-compliance to medical regimens
研究组 & 干预措施
Trabectedin
Experimental
Trabectedin: 1.5 mg/m² - 1.3 mg/m² (at investigator's discretion, with a top-dose of 2.6 total mg per cycle), given in 24-hour continuous infusion
干预措施: Trabectedin (Drug)
结局指标
主要结局
Overall tumour Response Rate, according to RECIST v 1.
时间窗: At weeks 6
Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
次要结局
- Choi criteria response rate(At weeks 6, 12,18, 30, 42)
- Progression Free Survival (PFS)(At 3 and 5 years)
- Clinical Benefit Rate(Month 6)
- Adverse events related to the treatment(Week 3, week 6, week 9, week 12, week 18, week 24, week 36, week 48, week 60, week 72)
- Overall Survival(At 3 and 5 years)
- Duration of response(At weeks 6, 12,18, 30, 42)
研究者
研究点 (7)
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