EUCTR2004-005106-79-ES进行中（未招募）不适用
Phase II study of gimatecan (ST 1481) as salvage treatment in patients with advanced breast cancer after anthracycline /taxanes-based chemotherapy regimen
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 43
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
- •1.Women with histologically/cytologically confirmed diagnosis of primary breast cancer
- •2.Presence of locally advanced to metastatic disease non-amenable to surgery or radiation therapy with curative intent
- •3.A maximum of 2 prior chemotherapies (which must have included previous treatment with anthracyclines and taxanes) for advanced disease (3 in case of a prior adjuvant chemotherapy).
- •4.At least one measurable (target) lesion according to RECIST criteria. Previously irradiated lesions will not be considered as target lesions.
- •5.Age > 18 years and < 75 years
- •6.ECOG performance status < 1.
- •7.Adequate hematological function: hemoglobin > 9 g/dl; neutrophils > 1.5 x 109/L; platelets > 150 x 109/L;
- •8.LVEF > 50% (or according to UNL of the Center) evaluated by means of ultrasound
- •9.Adequate liver and renal function
- •-alkaline phosphatase ? 1.5 x UNL, if bone metastases present, hepatic isoenzyme should be <1.5 UNL
- •-total serum bilirubin ? 1.5 times UNL regardless of liver involvement secondary to tumor
- •-ALT, AST ? 1.5 x UNL (? 2.5 x UNL in presence of liver metastases)
- •-albumin > 2.5 g/dl
- •-creatinine ? 1.5mg/dL or 133 ?mol/l
- •10.All previous therapies, including hormones, must have been discontinued > 4 weeks before study entry and all acute toxicities (excluding alopecia) of any prior therapy must have resolved to NCI-CTC (Version 2.0) Grade =1.
- •11.Life expectancy of at least 3 months.
- •12.Evidence of a signed and dated informed consent document indicating the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study
- •13.Willingness and ability to comply with the study protocol for the duration of the trial.
- •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
- •1.Prior radiation therapy to > 30% bone marrow
- •2.Active infection.
- •3.Any investigational agent received = 4 weeks prior to study entry and/or concurrent enrolment in another clinical trial .
- •4. Prior high dose chemotherapy treatment requiring hematopoietic stem cell rescue.
- •5.Previous major gastrointestinal surgery that could alter absorption or motility (i.e. active peptic ulcer, inflammatory bowel disease, known intolerance to lactose, malabsorption syndromes, intestinal sub-occlusion or previous major gastrointestinal surgery).
- •6.Inability to swallow
- •7.Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder.
- •8.Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
- •9.Previous concomitant malignancy at other site, other than basal or squamous cell carcinoma of the skin or in situ cervical carcinoma within 5 years.
- •10.Symptomatic brain metastases or leptomeningeal disease requiring therapy.
- •11.Pregnancy or lactation or unwillingness to use adequate method of birth control
研究者
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