NCT00633165Unknown2 期
A Phase II, Multicenter Study to Explore the Efficacy and Safety of Brostallicin in Patients With Myxoid Liposarcoma With (12:16) Translocation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To determine the overall response rate and response rate, as measured by RECIST criteria of myxoid liposarcoma with (12;16) translocation, to Brostallicin.
研究概览
简要总结
This is a Phase II, multicenter, open-label clinical trial designed to determine the efficacy and safety of Brostallicin when administered once every 3 weeks in patients with myxoid liposarcoma with (12;16) translocation. The primary objective of this study is to determine the response rate following Brostallicin administration.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has provided informed consent.
- •Histologically confirmed myxoid liposarcoma.
- •Patients with metastatic and/or unresectable myxoid liposarcoma that is progressive and standard curative measures do not exist or are no longer effective.
- •Patient has measurable tumor on CT, spiral CT, or MRI scan that meet RECIST criteria.
- •Age ≥18 years
- •Karnofsky performance status (KPS) ≥ 70% (see Appendix III).
- •Life expectancy of at least 3 months.
- •Acceptable liver function:
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 2.5 times ULN (if liver metastases are present, then ≤ 5 × ULN is allowed).
- •Acceptable renal function: For all patients serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal.
- •Acceptable hematologic status:
- •Absolute neutrophil count (ANC) ≥ 1500 cells/mm(3) (1.5 ×10(9)/L)
- •Platelet count ≥ 100,000 platelet/mm(3) (100 ×10(9)/L)
- •Hemoglobin ≥ 9 g/dL.
排除标准
- •Patient received any of the following within the specified time period prior to initiation of treatment in this study:
- •Chemotherapy, major surgery, significant traumatic injury, or irradiation, whether conventional or investigational within 28 days
- •Mitomycin-C or nitrosurea within 42 days.
- •ET-743 at any time (Stage 1 only).
- •Patients heavily pretreated with chemotherapy and radiation, defined as follows:
- •≥ 12 cycles of an alkylating agent-containing regimen, or
- •> 2 cycles carboplatin, or
- •> 2 cycles mitomycin C, or
- •irradiation to 25% of bone marrow-containing areas, or
- •high-dose chemotherapy requiring hematopoietic stem-cell reinfusion.
- •Known hypersensitivity to any study drug component.
- •Uncontrolled brain metastases in the judgement of the Investigator.
- •Abnormal cardiac or cardiovascular function, or serious cardiac illness or medical condition in the previous 6 months including, but not confined to:
- •New York Heart Association (NYHA) grade 2 or higher congestive heart failure (CHF) or who has had angioplasty or placement of coronary stents within the previous 6 months
- •Myocardial infarction within the past 6 months
- •High-risk uncontrolled arrhythmias
- •Angina pectoris that requires antianginal medication
- •Has clinically significant valvular heart disease
- •Evidence of transmural infarction on ECG
- •Poorly controlled hypertension (e.g., blood pressure: systolic >180 mm Hg or diastolic >100 mm Hg).
- •Pregnant or lactating females. All patients (males and females) who are fertile must agree to use an effective barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.
- •Not recovered from acute toxicity of all previous therapy prior to enrollment.
- •History of prior malignancies within 3 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast.
- •Any evidence of serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or obtaining informed consent.
- •Any active uncontrolled infection including AIDS, hepatitis B or C.
- •Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow up schedule.
结局指标
主要结局
To determine the overall response rate and response rate, as measured by RECIST criteria of myxoid liposarcoma with (12;16) translocation, to Brostallicin.
时间窗: Tumor measurements after every 2 cycles and there is no limit to the number of cycles.
次要结局
- To describe the safety profile of Brostallicin when administered every 3 weeks in this patient population.(Tumor measurements after every 2 cycles and there is no limit to the number of cycles.)
- Duration of response(Tumor measurements after every 2 cycles and there is no limit to the number of cycles.)
- To determine progression free survival.(Tumor measurements after every 2 cycles and there is no limit to the number of cycles.)
研究者
研究点 (2)
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