EUCTR2005-003097-19-HU进行中（未招募）不适用
A Phase 2 Study of HKI-272 in Subjects with Advanced Non-Small Cell Lung Cancer
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 188 人开始时间: 2007年3月21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
- 188
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.Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. For Arm C, diagnosis of adenocarcinoma with =10 pack-years smoking history and current non-smoker for =1 year
- •2.Tumor sample available and adequate for EGFR kinase domain sequence analysis. Sequencing must be performed prior to enrollment.
- •3.Progression following at least twelve weeks of treatment with Tarceva or Iressa (Arms A and B only)
- •4.At least 1 measurable target lesion as defined by modified RECIST criteria
- •5.Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (not declining within the past 2 weeks)
- •6.Age =18 years
- •7.Life expectancy of at least 12 weeks
- •8.Recovery from all clinically significant acute adverse effects of prior therapies (excluding alopecia)
- •9.Screening laboratory values within the following parameters: · ANC >=1.5 x 10 9/L (1,500/mm3)· Platelet count >= 75 x 10 9/L (75,000/mm3)· 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)
- •10.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 using contraceptives.
- •11.Willingness of male and 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.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).
- •2.Use of Tarceva or Iressa within 14 days of treatment Day 1 (Arms A and B) or any prior therapy with EGFR/HER2 targeting treatment (Arm C).
- •3.More than 3 prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease
- •4.Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 3 weeks of treatment day 1 (except for Tarceva or Iressa as above)
- •5.Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent >400 mg/m2
- •6.History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of >= 3.
- •7.Left ventricular ejection fraction less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram (ECHO)
- •8.QTc interval > 0.47 second
- •9.Pregnant or breast feeding women
- •10.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)
- •11.Inability or unwillingness to swallow the HKI-272 capsules
- •12.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 NSCLC)
研究者
相似试验
进行中（未招募）
1 期
Phase 2 Study of HKI-272 in Subjects with Advanced Breast CancerEUCTR2005-003098-26-FRWyeth Research Division of Wyeth Pharmaceuticals Inc.122
已完成
2 期
A clinical trial to study the effect of HKI-272 in subjects with Advanced breast cancerCTRI/2009/091/000817Wyeth Research Wyeth Pharmaceuticals India Private Limited A Subsidiary of Pfizer Inc137
进行中（未招募）
1 期
Phase 2 Study of HKI-272 in Subjects with Advanced Breast CancerEUCTR2005-003098-26-BEWyeth Research Division of Wyeth Pharmaceuticals Inc.122
进行中（未招募）
1 期
A Phase 1 / 2 Study of HKI-272 in combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer - study 203Metastatic breast cancer remains incurable and represents an area of unmet medical need globally. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) activation occurs in breast cancer. This activation contributes to the development and metastatic potential of breast cancer. Dual EGFR/HER2 inhibitors may have activity in the treatment of prior trastuzumab treated HER2 positive metastatic breast cancer.MedDRA version: 9.1Level: LLTClassification code 10055113Term: Breast cancer metastaticEUCTR2006-006412-29-BEWyeth Research Division of Wyeth Pharmaceuticals Inc.110
进行中（未招募）
1 期
A Phase I/II Study of HKI-272 in Combination With Vinorelbine in Subjects With Solid Tumors and Metastatic Breast Cancer.EUCTR2007-007885-39-BEWyeth Research Division of Wyeth Pharmaceuticals Inc.95