Neoplasms, BreastPhase 1NCT00849329
A Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2 Positive Breast Cancer
A Phase 1 study testing lapatinib and lapatinib plus esomeprazole in people with Neoplasms, Breast, run by GlaxoSmithKline at 4 sites in 3 countries.
Trial 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 positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neoplasms, Breast
- What is being tested?
- lapatinib and lapatinib plus esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 10 Mar 2009to 24 Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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].
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- 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 locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
South Korea2 sites
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Songpa-gu, Seoul, 138-736
United States1 site
GSK Investigational Site
Greenville, South Carolina, 29605
About this study
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
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.
- Conditions
- Neoplasms, Breast
- Being tested
- lapatinib, lapatinib plus esomeprazole
- Keywords
- lapatinib (GW572016), subject, pharmacokinetic, esomeprazole, proton-pump inhibitor, drug interaction, Phase 1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinibDrug
1250mg lapatinib
lapatinib plus esomeprazoleDrug
1250mg lapatinib plus esomeprazole 40mg
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | 1250mg lapatinib once daily in the morning Receives: Drug: lapatinib |
| Period 2 | Experimental | 1250mg lapatinib once daily in the morning in combination with esomeprazole 40mg once daily at bedtime. Receives: Drug: lapatinib plus esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Continue until disease progression or withdrawal consent
Secondary outcomes (1)
Safety and tolerability assessments including evaluation of adverse events and changes in laboratory values, and vital signs.
Measured: Continue until disease progression or withdrawal consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study start10 Mar 2009
- Primary completion24 Nov 2009
- Study completion24 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, BreastStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849329
- Sponsor's protocol ID
- 109275
- Status last verified
- Nov 2017
- First submitted
- 12 Feb 2009
- Last updated
- 14 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00849329
- Acronym / sponsor ID
- 109275
- Conditions
- Neoplasms, Breast
- Keywords
- lapatinib (GW572016), subject, pharmacokinetic, esomeprazole, proton-pump inhibitor, drug interaction, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2009 (actual)
- Primary completion
- 24 Nov 2009 (actual)
- Study completion
- 24 Nov 2009 (actual)
- First posted
- 23 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: lapatinib1250mg lapatinib once daily in the morning |
| Period 2 | Experimental | Drug: lapatinib plus esomeprazole1250mg lapatinib once daily in the morning in combination with esomeprazole 40mg once daily at bedtime. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lapatinib1250mg lapatinib | Drug | Period 1 |
| lapatinib plus esomeprazole1250mg lapatinib plus esomeprazole 40mg | Drug | Period 2 |
Primary outcome
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
Time frame: Continue until disease progression or withdrawal consent
1 secondary outcome
Safety and tolerability assessments including evaluation of adverse events and changes in laboratory values, and vital signs.
Time frame: Continue until disease progression or withdrawal consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Results for study 109275 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lapatinib and lapatinib plus esomeprazole in people with Neoplasms, Breast, run by GlaxoSmithKline at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea, United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Continue until disease progression or withdrawal consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.