EUCTR2007-000035-25-IT进行中（未招募）不适用
A multicenter Phase II clinical trial of neoadjuvant trabectedin (Yondelis) in patients with localized myxoid / round cell liposarcoma. - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PHARMA MAR
- 入组人数
- 22
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
- •PatientŽs written informed consent before any study-specific procedure Adult patients (more than or equal to 18 years)
- •Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
- •Clinical evidence of localized, non-metastatic tumor, including locally recurring disease after initial surgery
- •Measurable disease (by RECIST)
- •No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
- •Hematologic variables:
- •oHemoglobin more than or equal to 9 g/dL
- •oAbsolute neutrophil count (ANC)more than or equal to 1,500/µL, and oPlatelet count more than or equal to 100,000/µL
- •Serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance more than or equal to 30 mL/min
- •Creatinine phosphokinase (CPK) less than or equal to 2.5 ULN
- •Hepatic function variables:
- •oTotal bilirubin less than or equal to ULN
- •oTotal alkaline phosphatase less than or equal to 2.5 ULN, or if > 2.5 ULN consider alkaline phosphatase liver fraction or GGT or 5? nucleotidase must be less than or equal to ULN
- •o AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be less than or equal to 2.5 x ULN
- •Albumin more than or equal to 25 g/L
- •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
- •Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone
- •Pregnant or lactating women or any patient of childbearing potential who are not employing adequate contraception
- •History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer
- •Known distant metastases
- •Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias
- •Psychiatric disorder that prevents compliance with protocol
- •Active viral hepatitis or chronic liver disease
- •Active infection
- •Any other unstable medical condition
研究者
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