NCT00821054已完成1 期
An Open Label Study to Examine the Effects of Low-Fat and High-Fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Protocol specified pharmacokinetic parameters
研究概览
简要总结
This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of lapatinib administered after a high or low-fat meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic, histologically confirmed breast cancer that over-expresses ErbB2 (3+ by IHC; FISH or CISH positive).
- •Is at least 18 years of age and not greater than 65 years of age.
- •Is male or female. A female is eligible to enter and participate in the study if she is of:
- •Non-childbearing potential (i.e. physiologically incapable of becoming pregnant), including any female who: has had a hysterectomy; has had a bilateral oophorectomy (ovariectomy); has had a bilateral tubal ligation, or is post-menopausal (a demonstration of total cessation of menses for ≥ 1 year) or in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory.
- •Childbearing potential, has a negative serum pregnancy test at Screening and agrees to one of the following: double-barrier contraception (condom with spermicidal jelly, foam, suppository, or film; diaphragm with spermicide; or male condom and diaphragm); complete abstinence from sexual intercourse from two weeks prior to administration of the study drug, throughout the active study treatment period; vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
- •Is able to swallow and retain oral medication.
- •ECOG performance status 0 to
- •Adequate bone marrow function.
- •Hemoglobin ≥ 9 gm/dL.
- •Absolute granulocyte count ≥1,500/mm3 (1.5 x 109/L).
- •Platelets ≥ 75,000/mm3 (75 x 109/L).
- •Calculated creatinine clearance (CrCl) ≥ 50 ml/min based on Cockcroft and Gault
- •Total bilirubin ≤ 1.5 X upper limit of normal of institutional values and INR ≤ 1.
- •Alanine transaminase (ALT) ≤ three times the upper limit of the institutional values or ≤ five times ULN with documented liver metastases.
- •Has a left ventricular ejection fraction (LVEF) within the normal institutional range based on ECHO or MUGA.
- •Life expectancy of ≥12 weeks
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
排除标准
- •Is pregnant or lactating.
- •Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the stomach or small bowel.
- •Has current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
- •Has evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease. Subjects with brain metastases treated by surgery and/or radiotherapy are eligible if neurologically stable and do not require steroids or anticonvulsants.
- •Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
- •Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product such as gefitinib [Iressa] and erlotinib [Tarceva].
- •Has received treatment with any investigational drug in the previous four weeks.
- •Has received chemotherapy, immunotherapy, biologic therapy or hormonal therapy for the treatment of cancer within the past 14 days, with the exception of mitomycin C which is restricted for the past six weeks.
- •Is receiving any prohibited medication within the timeframe indicated on the prohibited medication list for this study.
- •Has physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- •Has inadequate venous access for protocol-related blood draws.
- •Clinically significant electrocardiogram (ECG) abnormality.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Has consumed red wine, seville oranges, grapefruit or grapefruit juice and/or kumquats, pummelos, exotic citrus fruit (i.e. star fruit, bitter melon), grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
研究组 & 干预措施
Period 1
Experimental
Treatment A, B or C
干预措施: Lapatinib (Drug)
Period 2
Experimental
Treatment A, B or C
干预措施: Lapatinib (Drug)
Period 3
Experimental
Treatment A, B or C
干预措施: Lapatinib (Drug)
结局指标
主要结局
Protocol specified pharmacokinetic parameters
时间窗: 3 weeks
次要结局
- Safety and tolerability as assessed by evaluation of adverse events (AEs), changes in laboratory values, and vital signs(3 weeks)
研究者
研究点 (1)
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