NCT00849329已完成1 期
An Open-Label, Two-Part, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2
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
- 12
- 试验地点
- 1
- 主要终点
- The area under the concentration versus time curve, minimum observed concentration, maximum observed concentration, time at which it occurs, and lag time in the appearance of measurable plasma concentrations of lapatinb
研究概览
简要总结
This study will characterize the effect of elevated gastric pH mediated by the proton-pump inhibitor, esomeprazole, on the relative bioavailability of lapatinib in subjects with metastatic ErbB2 positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 overexpresses ErbB2 (3+ by IHC, FISH, or CISH positive).
- •18 years to 65 years of age.
- •Is male or female (of non childbearing potential or willing to use contraception as specified in the protocol).
- •Is able to swallow and retain oral medication.
- •ECOG performance status 0 to
- •Provided written informed consent.
- •Adequate bone marrow function (as specified in the protocol).
- •Calculated creatinine clearance (CrCl) greater than or equal to 50 ml/min based on Cockcroft and Gault.
- •Total bilirubin less than or equal to 1.5 X upper limit of normal of institutional values.
- •Alanine transaminase (ALT) less than or equal to 3 times the upper limit of the institutional values or less than or equal to 5 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 greater than or equal to 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
- •Pregnant or lactating woman.
- •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.
- •Has a known immediate or delayed benzimidazole 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. (with the exception of lapatinib).
- •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, and lapatinib. Subjects receiving lapatinib prior to study entry are eligible to participate in the study.
- •Is receiving any prohibited medication within the timeframe indicated on the prohibited medication list in the protocol.
- •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 abnormality.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Consumption of 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 seven days prior to the first dose of study medication.
研究组 & 干预措施
Period 1
Experimental
1250mg lapatinib once daily in the morning
干预措施: lapatinib (Drug)
Period 2
Experimental
1250mg lapatinib once daily in the morning in combination with esomeprazole 40mg once daily at bedtime.
干预措施: lapatinib plus esomeprazole (Drug)
结局指标
主要结局
The area under the concentration versus time curve, minimum observed concentration, maximum observed concentration, time at which it occurs, and lag time in the appearance of measurable plasma concentrations of lapatinb
时间窗: Continue until disease progression or withdrawal consent
次要结局
- Safety and tolerability assessments including evaluation of adverse events and changes in laboratory values, and vital signs.(Continue until disease progression or withdrawal consent)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Drug-drug Interaction Study of Oral 1250 mg of Vatalinib Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor in Healthy Sterile or Postmenopausal Female VolunteersHealthyNCT00426452Novartis24
已完成
1 期
A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult ParticipantsHealthy ParticipantsNCT06366243Cerevel Therapeutics, LLC20
已完成
1 期
PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult SubjectsGastroesophageal Reflux DiseaseNCT03069963Sanofi24
已完成
1 期
A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy ParticipantsHealthy ParticipantsNCT04941755Bristol-Myers Squibb22
招募中
1 期
A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy ParticipantsHealthy VolunteersNCT05866627Bristol-Myers Squibb76