EUCTR2004-005276-16-ES进行中（未招募）1 期
An open-label multicenter randomized Phase 3 study comparing the combination of DOXIL®/CAELYX® and YONDELIS™ with DOXIL®/CAELYX® alone in subjects with advanced relapsed ovarian cancer.
Pharma Mar S.A. Sociedad Unipersonal0 个研究点目标入组 650 人开始时间: 2005年9月2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
- 650
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
- Female
入选标准
- •Subjects must satisfy all of the following criteria to be enrolled in the study:
- •· Female, age 18 or older
- •· Histologically proven epithelial ovarian cancer
- •· Prior treatment with only 1 chemotherapy regimen (including adjuvant therapy)
- •· No previous exposure to anthracyclines or YONDELIS
- •· Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •· Recurrence or progression more than six months after the beginning (first dose) of the initial line of platinum-based chemotherapy for ovarian cancer
- •· Measurable or non-measurable disease that can be evaluated by response evaluation criteria in solid tumors (RECIST) criteria for response and/or progression and documented by radiographic methods such as magnetic resonance imaging (MRI) or computed tomography (CT) scan
- •· For subjects with non-measurable but evaluable disease, CA-125 level 2 x upper limit of normal (ULN) on at least 2 measurements at least 1 week apart, the second assessment prior to inclusion in this study
- •· Adequate organ function as evidenced by the following peripheral blood counts or serum chemistry values within 7 days prior to randomization:
- •- hemoglobin =9 g/dL
- •- absolute neutrophil count (ANC) =1,500/µL, and
- •- platelet count =100,000/µL
- •- serum creatinine = 1.5 mg/dL (<132.6 µmol/L) or creatinine clearance =60 mL/min
- •· Hepatic function variables
- •- Total bilirubin = 1.5
- •- Total alkaline phosphatase = 1.5 ULN, or if >1.5 ULN, then alkaline phosphatase liver fraction must be = ULN
- •AST and ALT must be = 2.5 x ULN
- •· If cardiac history, left ventricular ejection fraction (LVEF) within normal limits for the institution
- •· Adequately recovered from the acute toxicity of any prior treatment
- •· Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •· At investigative sites that are participating in the CellSearch™ or genomic testing portion of this protocol, the subject (or their legally acceptable representative) must sign the informed consent forms for genetic testing and CellSearch™, indicating whether or not subjects wish to participate in these parts of the study. Participation in the pharmacogenomics and CellSearch aspects of this study is not mandatory.
- •Are the trial subjects under 18?
- •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
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •· Subjects treated with more than 1 prior chemotherapy regimen (including adjuvant therapy)
- •· Refractory disease, defined as disease progression within six months of the beginning (first dose) of the initial line of platinum-based chemotherapy for ovarian cancer
- •· Isolated rise in CA-125 without documented radiological evidence of disease progression
- •· Prior exposure to anthracyclines or YONDELIS
- •· Subjects unwilling or unable to have a central venous catheter
- •· Subjects of child-bearing potential not employing adequate contraception
- •· Less than 4 weeks from radiation therapy or last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy.
- •· History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or more
- •· Known leptomeningeal metastasis
- •· Active viral hepatitis or history of liver disease
- •· Myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure (Attachment 1), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
- •· Any other unstable medical conditions, such as:
- •- Uncontrolled diabetes
- •- Psychiatric disorder that prevents compliance with protocol including dementia
- •- Uncontrolled seizures
- •- Acute deep vein thrombosis requiring intravenous or subcutaneous anticoagulant therapy
- •- Active infection
研究者
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