Last updated: 11/07/2018 02:35:19
A Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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
Timeframe: Continue until disease progression or withdrawal consent
Secondary outcomes:
Safety and tolerability assessments including evaluation of adverse events and changes in laboratory values, and vital signs.
Timeframe: Continue until disease progression or withdrawal consent
Interventions:
Drug: lapatinib
Drug: lapatinib plus esomeprazole
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kevin M Koch, Young-Hyuck Im, Sung-Bae Kim, Ander Urruticoechea Ribae, Joseph Stephenson, Jeffrey Botbyl, Leanne Cartee, Jane Holshouser, Derry Ridgway. Effects of Esomeprazole on the Pharmacokinetics of Lapatinib in Breast Cancer Patients. Clin Pharmacol Drug Devel. 2013;DOI: 10.1002/cpdd.45
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
March 2009 to November 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Metastatic, histologically confirmed breast cancer that overexpresses ErbB2 (3+ by IHC, FISH, or CISH positive).
- 18 years to 65 years of age.
- Pregnant or lactating woman.
- Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the stomach or small bowel.
Inclusion and exclusion criteria
Inclusion criteria:
- 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 criteria:
- 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.
Trial location(s)
Location
GSK Investigational Site
Hospitalet de Llobregat (Barcelona), Spain, 08907
Status
Study Complete
Location
GSK Investigational Site
songpa-gu, Seoul, South Korea, 138-736
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29605
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-24-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 109275 can be found on the GSK Clinical Study Register.
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