Status:
COMPLETED
A Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2 Positive Breast Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 posit...
Eligibility Criteria
Inclusion
- 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 2.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00849329
Start Date
March 10 2009
End Date
November 24 2009
Last Update
November 14 2017
Active Locations (4)
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1
GSK Investigational Site
Greenville, South Carolina, United States, 29605
2
GSK Investigational Site
Seoul, South Korea, 135-710
3
GSK Investigational Site
Songpa-gu, Seoul, South Korea, 138-736
4
GSK Investigational Site
Hospitalet de Llobregat (Barcelona), Spain, 08907