EUCTR2005-001537-15-DE进行中（未招募）不适用
Open-label trial of imatinib mesylate (Glivec, formerly known as STI571) in combination with vinorelbine (Navelbine) for patients with advanced breast carcinoma - ICO
ovartis Pharma GmbH0 个研究点目标入组 30 人开始时间: 2005年10月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •2.Patients >= 18 years of age.
- •3.Histologically documented diagnosis of invasive breast cancer, which is locally advanced or metastatic
- •4.Previous anthracycline containing chemotherapy
- •5.Immunohistochemical documentation of c-kit (CD117) and /or PDGF-receptor expression by tumor
- •6.Preferably tumor samples should be taken within 6 weeks of study entry, at last primary tumor tissue have to be available for expression analysis
- •7.At least one measurable site of disease (as defined by Southwestern Oncology Group Solid Tumor Response Criteria, see Appendix 2), or other response assessment criteria, as appropriate.
- •8.Performance status 0,1 or 2 (ECOG) (see Section 7.1)
- •9.Adequate end organ function, defined as the following:
- •total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL, creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L.
- •10.Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential.Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- •11.Written, voluntary informed consent.
- •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.Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
- •2.Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
- •3.Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
- •4.Female patients who are pregnant or breast-feeding.
- •5.Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
- •6.Patient has a known brain metastasis.
- •7.Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- •8.Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- •9.Patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
- •10.Patient previously received radiotherapy to ? 25 % of the bone marrow
- •11.Patient had a major surgery within 2 weeks prior to study entry.
- •12.Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- •13.Patient received either Vinorelbine or Imatinib in previous treatment regimens
- •14.Breast tumor does not show expression for c-kit or PDGF-receptor
研究者
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