EUCTR2004-001177-25-HU进行中（未招募）不适用
Cardiac safety profile of Caelyx therapy in anthracyclin pretreated metastatic breast cancer patients.
Schering-Plough CE AG Hungarian Commercial Representative Office0 个研究点目标入组 50 人开始时间: 2004年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •- Women with histologically or cytologically confirmed metastatic breast cancer (no prior chemotherapy for metastatic disease).
- •- Prior treatment with an anthracyclin-containing regimen in the adjuvant setting (cumulative dose >240mg/m2 and <360mg/m2 doxorubicin or >430mg/m2 and <650mg/m2 epirubicin).
- •- >18 years of age.
- •- Documented measurable and/or evaluable metastatic breast cancer by appropriate radiological imaging (CT scan and/or MRI).
- •- Performance status of at least 60% (Karnofsky index) and a life expectancy of at least 12 weeks.
- •- Left ventricular ejection fraction > 50%.
- •- Normal organ function, except if abnormal due to tumor involvement.
- •Adequate bone marrow function as indicated:
- •Platelets > 100,000/mm3
- •Hemoglobin > 9 g/dL
- •Neutrophils > 1,500/mm3
- •Adequate renal function as indicated by:
- •Serum Creatinine <1.5 x the upper limit of normal
- •Adequate liver function, as indicated by:
- •Bilirubin and AST or ALT < 2 times upper limit of normal (< 4 times upper limit of normal when related to primary disease)
- •- Subjects must be capable to demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- •- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
- •- Subjects must understand and be able to adhere to the dosing and visit schedules.
- •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
- •- Patient is pregnant or is breast feeding.
- •- Patients with moderate or severe heart failure (NYHA class III/IV).
- •- Patient is hypersensitive to anthracycline therapy or has a history of severe hypersensitivity reactions to products containing Cremophor EL (e.g., cyclosporin for injection concentrate and teniposide for injection concentrate).
- •- Age < 18 years.
- •- Prior chemotherapy for metastatic disease.
- •- Clinically significant hepatic disease (except liver metastases of primary disease).
- •- Patient has uncontrolled bacterial, viral, or fungal infection.
- •- Radiotherapy in the last 4 weeks or prior radiation therapy to more than one-third of the hemopoietic sites.
- •- Any other currently known malignancy or pre-malignant lesions or any history of other malignancy within the past five years (except non-melanoma skin cancer and surgically cured cervical cancer).
- •- Patient has symptomatic metastasis to the brain.
- •- Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
- •- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
- •- Documented HIV infection.
- •- Any condition (medical, social, psychological) which would prevent adequate follow-up.
研究者
相似试验
终止
4 期
Safety Study of CAELYX in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines (Study P04057)(TERMINATED)Breast NeoplasmNCT00779285Merck Sharp & Dohme LLC1
招募中
3 期
The cardiovascular safety of efficacy cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants established cardiovascular diseasecardiovascular diseaseNL-OMON55925ovo Nordisk160
已完成
不适用
A cohort study of anthracycline-induced cardiotoxicityAll patients scheduled for anthracycline-containing therapy for various kinds of tumorsJPRN-UMIN000022984niversity of Tsukuba500
进行中（未招募）
不适用
Prevention of anthracycline-induced cardiotoxicity: a multicentre randomizedtrial comparing two therapeutic strategies.EUCTR2012-002248-26-ITISTITUTO EUROPEO DI ONCOLOGIA
进行中（未招募）
不适用
EFFICACY AND SAFETY OF ERAXIS™/ECALTA® (ANIDULAFUNGIN) COMPARED TO CANCIDAS® (CASPOFUNGIN) IN PATIENTS WITH CANDIDA DEEP TISSUE INFECTIOEUCTR2008-005278-11-PTPfizer Inc, 235 East 42nd Street, New York, NY 1001760