EUCTR2005-003098-26-BE进行中（未招募）1 期
Phase 2 Study of HKI-272 in Subjects with Advanced Breast Cancer
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 122 人开始时间: 2006年2月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
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.Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV breast cancer not curable with available therapy.
- •2.Progression following at least six weeks of standard doses of Herceptin (trastuzumab) or a Herceptin containing regimen in a metastatic or locally advanced setting; or progression on or following Herceptin containing adjuvant therapy (Arm A only). Up to 20 subjects with HER2+ breast cancer with prior lapatinib exposure may be enrolled in ARM A only.
- •3.Tumor tissue available and adequate for HER2 gene amplification.
- •4.HER2 gene amplified tumor by FISH (fluorescence in situ hybridization).
- •5.At least 1 measurable lesion as defined by modified RECIST criteria.
- •6.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (not declining within past 2 weeks).
- •7.Women aged >= 18 years.
- •8.Life expectancy of at least 12 weeks.
- •9. Recovery from all clinically significant acute adverse effects of prior therapies (excluding alopecia).
- •10.Screening laboratory values within the following parameters:
- •ANC>= 1.5 x 10^9/L (1,500/mm^3)
- •Platelet count>= 75 x 10^9/L (75,000/mm^3)
- •Hemoglobin >= 8.0 g/dL (80g/L)
- •Serum creatinine <= 1.5 x upper limit of normal (ULN)
- •Total bilirubin<= 1.5 x ULN
- •AST and ALT<= 2.5 x ULN (<= 5 x ULN if liver metastases are present)
- •11.For women of child bearing potential, a negative serum pregnancy test result before study entry. A woman of child bearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or are using contraceptives.
- •12.Willingness of female subjects, who are not surgically sterile or postmenopausal, to use medically acceptable methods of birth control for the duration of the study and for 28 days after the last dose of test article.
- •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 treatment with Herceptin or any HER2-targeted treatment (Arm B only)
- •2.More than 4 prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease.
- •3.Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1.
- •4.Extensive visceral disease including bilateral diffuse lymphangitic involvement of the lung with more than 50% lung involvement, extensive hepatic involvement defined as involvement of more than one third of the liver confirmed by CT or MRI scan.
- •5.Subjects with bone or skin as the only site of measurable disease
- •6.Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (subjects with a history of CNS metastases or cord compression are allowable if they have been definitively treated and are clinically stable for at least 4 weeks before first dose of test article). 7.History of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association [NYHA] functional classification of >=3), angina, myocardial infarction, or ventricular arrhythmia.
- •8.Left ventricular ejection fraction less than 50% measured by multigated blood pool imaging of the heart (MUGA) scanning or echocardiogram (ECHO)
- •9.QTc interval > 0.47 second
- •10.Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent > 400 mg/m^2
- •11.Pregnant or breast feeding women
- •12.Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom (e.g, Crohn’s disease, malabsorption, or Grade >=2 diarrhea of any etiology at baseline)
- •13.Inability or unwillingness to swallow the HKI-272 capsules
- •14.Evidence of significant medical illness or abnormal laboratory finding that would, in the investigator’s judgment, make the subject inappropriate for this study. Examples include, but are not limited to, serious active infection (i.e. requiring intravenous antibiotic or antiviral agent), uncontrolled major seizure disorder, any other active malignancy (except for breast cancer).
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