NCT00085020已完成1 期
A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Trastuzumab [Herceptin†]
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
研究概览
简要总结
RATIONALE: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving GW572016 with trastuzumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given together with trastuzumab in treating patients with metastatic breast cancer that overexpresses HER2/neu.
详细描述
OBJECTIVES:
Primary
- Determine the optimally tolerated regimen of GW572016 when administered with trastuzumab (Herceptin^®) in patients with metastatic breast cancer that overexpresses HER2/neu.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the clinical response in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed breast cancer
- •Metastatic disease
- •Measurable or evaluable disease
- •HER2/neu overexpression (2+ or 3+) confirmed by immunohistochemistry and/or HER2 gene amplification by fluorescence in situ hybridization
- •Brain metastases treated by surgery and/or radiotherapy allowed provided the following criteria are met:
- •Neurologic status stable 2 weeks after discontinuing dexamethasone
- •No concurrent anticonvulsants that induce metabolism (e.g., phenytoin, carbamazepine, or phenobarbital)
- •18 and over
- •Male or female
- •Karnofsky 70-100%
- •Life expectancy, At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if patient has liver metastases)
- •Bilirubin < 1.5 mg/dL
- •Creatinine clearance > 30 mL/min
- •Cardiovascular
- •LVEF > 50%
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 weeks after study participation
- •Adequate venous access
- •Able to swallow and retain oral medication
- •Prior adjuvant/neoadjuvant chemotherapy allowed
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin.
- •More than 4 weeks since prior radiotherapy
- •More than 4 weeks since prior major surgery
- •Recovered from all prior therapy
- •More than 28 days since prior participation in another investigational study
- •More than 28 days since prior investigational drugs
排除标准
- •extensive tumor, pleural effusions, or parenchymal masses) resulting in dyspnea at rest
- •uncontrolled brain metastases or leptomeningeal disease
- •prior myocardial infarction
- •pre-existing cardiac dysfunction (e.g., congestive heart failure)
- •clinically significant cardiac disease
- •angina pectoris
- •symptomatic intrinsic pulmonary disease (e.g., asthma or chronic obstructive pulmonary disease) resulting in dyspnea at rest
- •pregnant or nursing
- •active infection
- •known hypersensitivity to Chinese Hamster Ovary cell proteins or any component of this product
- •known immediate or delayed hypersensitivity reaction or idiosyncrasy to products of similar chemical composition as study drug
- •known contraindications to trastuzumab (Herceptin^®)
- •malabsorption syndrome
- •disease significantly affecting gastrointestinal function
- •psychiatric disorder that would preclude study compliance
- •other serious illness or condition
- •concurrent biologic therapy
- •prior cumulative dose of doxorubicin > 400 mg/m^2 (including liposomal doxorubicin)
- •concurrent hormonal therapy*
- •concurrent glucocorticoids
- •concurrent radiotherapy
- •prior major resection of the stomach or small bowel that could affect absorption of GW572016
- •concurrent cytotoxic therapy
- •other concurrent anticancer therapy
- •other concurrent investigational drugs during and for 28 days after study treatment
- •concurrent administration of any of the following medications or substances:
- •Antibiotics
- •Clarithromycin
- •Erythromycin
- •Troleandomycin
- •Ciprofloxacin
- •Norfloxacin
- •Rifabutin
- •HIV antivirals
- •Delaviridine
- •Indinavir
- •Nelfinavir
- •Ritonavir
- •Saquinavir
- •Efavirenz
- •Nevirapine
- •Amprenavir
- •Lopinavir
- •Anticonvulsants
- •Phenytoin
- •Carbamazepine
- •Phenobarbital
- •Antidepressants
- •Fluoxetine
- •Nefazodone
- 另有 18 项未显示
研究者
研究点 (2)
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