Neoplasms, BreastPhase 1NCT00650910
Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive Breast Cancer
A Phase 1 study testing lapatinib and Digoxin in people with Neoplasms, Breast, run by GlaxoSmithKline at 4 sites in 3 countries.
Trial summary
This is a two part study looking at the effect of lapatinib on concentrations of digoxin in the blood when both drugs are dosed together in Part 1; and looking at the safety and antitumor effect of lapatinib when used together with possible additional anticancer therapy as chosen at the doctor's discretion. 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 Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 23 Apr 2008to 10 Jul 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).
- 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
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- 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
- 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, and through the Week 10 Visit.
- 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 2.
- Provided written informed consent.
- Adequate bone marrow function.
- Clinical lab results with ranges as stated per protocol.
- Potassium and magnesium within the normal range of institutional values. [Serum potassium or magnesium values that fall outside the normal range may be repeated once at the discretion of the investigator, provided they are considered to be clinically insignificant.]
- Has a left ventricular ejection fraction (LVEF) within the normal institutional range based on ECHO or MUGA.
- Life expectancy of at least 12 weeks
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Is pregnant or lactating.
- Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the stomach or small bowel.
- 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 CTCAE Grade 2 or greater hypercalcemia as per protocol.
- Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to digoxin or 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.
- 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 currently receiving amiodarone or has received amiodarone in the six months prior to screening.
- Is receiving any prohibited medication within the timeframe indicated on the prohibited medication list as per protocol.
- Has physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Subjects with certain disorders involving heart failure associated with preserved left ventricular ejection fraction such as restrictive cardiomyopathy, constrictive pericarditis, amyloid heart disease, acute cor pulmonale, idiopathic hypertrophic subaortic stenosis, or any other cardiac condition that would preclude the administration of digoxin.
- Has a clinically significant electrocardiogram (ECG) abnormality, including but not limited to sinus node disease, pre-existing incomplete AV block, and Wolff Parkinson-White Syndrome.
- Has inadequate venous access for protocol-related blood draws.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
South Korea2 sites
GSK Investigational Site
Seodaemun-gu, Seoul, 120-752
GSK Investigational Site
Seoul, 110-744
United States1 site
GSK Investigational Site
Albuquerque, New Mexico, 87131
About this study
Official title: An Open-Label, Two-Part, Single Sequence Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally Administered Digoxin in Subjects With Metastatic ErbB2 Positive Breast Cancer
This is a two part study looking at the effect of lapatinib on concentrations of digoxin in the blood when both drugs are dosed together in Part 1; and looking at the safety and antitumor effect of lapatinib when used together with possible additional anticancer therapy as chosen at the doctor's discretion.
- Conditions
- Neoplasms, Breast
- Being tested
- lapatinib, Digoxin
- Keywords
- lapatinib, Metastatic ErbB2 positive breast cancer, digoxin
- 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
1500 mg oral lapatinib starting Day 2 continuing through Day 9. Part 2 subjects received 1500mg daily through week 10.
DigoxinDrug
Also called lapatinib
0.5mg on Days 1 and 9
| Study group | Role | What they receive |
|---|---|---|
| lapatinib + digoxin | Experimental | All subjects received 0.5mg digoxin on Days 1 and 9 with daily dosing of 1500mg oral lapatinib starting on Day 2 and continuing through Day 9. Subjects could continue past Day 9 on daily oral lapatinib until Week 10 when they could transfer into a rollover study (EGF19060 or EGF111767). Receives: Drug: lapatinib; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the effect of repeat oral dose lapatinib treatment on the pharmacokinetics of a single oral dose of digoxin in adult subjects with metastatic ErbB2 positive breast cancer.
Measured: 10 days
Secondary outcomes (1)
Safety and tolerability assessments including evaluation of adverse events (AEs) and changes in laboratory values, and vital signs.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study start23 Apr 2008
- Primary completion10 Jul 2009
- Study completion10 Jul 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT00650910
- Sponsor's protocol ID
- EGF110557
- Status last verified
- Nov 2017
- First submitted
- 28 Mar 2008
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 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 Lapatinib on the Pharmacokinetics of Orally Administered Digoxin in Subjects With Metastatic ErbB2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00650910
- Acronym / sponsor ID
- EGF110557
- Conditions
- Neoplasms, Breast
- Keywords
- lapatinib, Metastatic ErbB2 positive breast cancer, digoxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2008 (actual)
- Primary completion
- 10 Jul 2009 (actual)
- Study completion
- 10 Jul 2009 (actual)
- First posted
- 2 Apr 2008 (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 is a two part study looking at the effect of lapatinib on concentrations of digoxin in the blood when both drugs are dosed together in Part 1; and looking at the safety and antitumor effect of lapatinib when used together with possible additional anticancer therapy as chosen at the doctor's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lapatinib + digoxin | Experimental | Drug: lapatinib, Drug: DigoxinAll subjects received 0.5mg digoxin on Days 1 and 9 with daily dosing of 1500mg oral lapatinib starting on Day 2 and continuing through Day 9. Subjects could continue past Day 9 on daily oral lapatinib until Week 10 when they could transfer into a rollover study (EGF19060 or EGF111767). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Metastatic, histologically confirmed breast cancer that overexpresses 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:
- Has had a hysterectomy
Key exclusion criteria (14 listed)
- Is pregnant or lactating.
- Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the stomach or small bowel.
- 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 CTCAE Grade 2 or greater hypercalcemia as per protocol.
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 |
|---|---|---|
| lapatinib1500 mg oral lapatinib starting Day 2 continuing through Day 9. Part 2 subjects received 1500mg daily through week 10. | Drug | lapatinib + digoxin |
| DigoxinAlso: lapatinib0.5mg on Days 1 and 9 | Drug | lapatinib + digoxin |
Primary outcome
To characterize the effect of repeat oral dose lapatinib treatment on the pharmacokinetics of a single oral dose of digoxin in adult subjects with metastatic ErbB2 positive breast cancer.
Time frame: 10 days
1 secondary outcome
Safety and tolerability assessments including evaluation of adverse events (AEs) and changes in laboratory values, and vital signs.
Time frame: 10 days
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 17 Nov 2017.
- Results for study EGF110557 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 Digoxin 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 22 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 17 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, Canada. 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?
To characterize the effect of repeat oral dose lapatinib treatment on the pharmacokinetics of a single oral dose of digoxin in adult subjects with metastatic ErbB2 positive breast cancer. (time frame: 10 days). 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 17 Nov 2017.