EUCTR2006-002080-93-SE进行中（未招募）1 期
An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects with ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer - Expanded Access study of Lapatinib and Capecitabine in ErbB2 Positive Breast Cancer
Glaxo SmithKline Research and Development Limited0 个研究点目标入组 4,000 人开始时间: 2007年1月8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
- 4,000
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
- •1. Signed informed consent;
- •2. Subjects must not be eligible for another ongoing lapatinib clinical study;
- •3. Subjects are allowed to have received prior lapatinib therapy in another clinical study; previous capecitabine therapy is permitted;
- •4. Prior treatment with hormonal therapy is allowed;
- •5. Subjects must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy which must include ALL of the following: prior treatment with an anthracycline, a taxane and trastuzumab alone or in combination with other therapy. Trastuzumab administered in the adjuvant, locally advanced or metastatic settings is allowed;
- •6. Subjects must have tumours that overexpress ErbB2 defined as 3+ by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry;
- •7. Subjects (male or female) must be = 18 years of age;
- •8. Subjects must have an ECOG Performance Status of 0 to 2;
- •9. Life expectancy > 8 weeks;
- •10. Subjects must have recovered or stabilized sufficiently from side effects associated with prior treatments before beginning treatment with lapatinib and capecitabine;
- •11. Subjects with central nervous system (CNS) metastases are eligible, providing treatment with prohibited medications are not required;
- •12. Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram (ECHO). Measurements with MUGA scans are allowed if echocardiograms cannot be performed. Subjects with symptomatic angina, arrhythmias, or congestive heart failure are not eligible;
- •13. Subjects must not be taking any medication listed in the 'Prohibited Medications' listing of the protocol;
- •14. Able to swallow and retain oral medications;
- •15. Subjects must complete all screening assessments as outlined in the protocol;
- •16. Subjects must have adequate hematologic, hepatic and renal function as defined in the protocol.
- •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. Pregnant or lactating females at anytime during the study;
- •2. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. In addition, subjects with ulcerative colitis are also excluded;
- •3. Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety;
- •4. Unresolved or unstable serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
- •5. Uncontrolled infection;
- •6. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
- •7. Active cardiac disease, defined as one or more of the following:
- •- History of uncontrolled or symptomatic angina
- •- History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
- •- Myocardial infarction < 6 months from study entry
- •- Uncontrolled or symptomatic congestive heart failure
- •- Ejection fraction below the institutional normal limit
- •- Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- •8. Subjects receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy (including ErbB1 and/or ErbB2 inhibitor), or hormonal therapy for treatment of their cancer. Hormone therapy for ovarian supression is allowed. Concurrent treatment with bisphosphonates is allowed;
- •9. History of allergic reactions attributed to compounds of similar chemical composition (quinazolines) to lapatinib or to any excipients;
- •10. History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or to any excipients;
- •11. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •12. Subjects meeting any of the following criteria must not be enrolled in the study: Have current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
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