Neoplasms, BreastPhase 1NCT00359190
Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer
A Phase 1 study testing lapatinib in people with Neoplasms, Breast, run by GlaxoSmithKline at 10 sites in 2 countries.
Trial summary
This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Breast
- What is being tested?
- lapatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 29 Jun 2004to 9 Jan 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical labs are within acceptable ranges.
- A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
- At least 18 years of age.
- Females must meet certain criteria specified in protocol.
- Ability to swallow and retain oral medication.
- Ability to follow and understand directions.
Who cannot join
- Female who is pregnant or lactating.
- Medically unfit by the doctor as a result of the medical interview or physicals.
- Received treatment of an investigational drug within 4 weeks of study start.
- Currently receiving treatment with prohibited meds listed in protocol.
- Had major surgery in previous 2 weeks.
- Had prior radiation therapy to the chest to treat this incidence of breast cancer.
- Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
- Has a malabsorption syndrome.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
GSK Investigational Site
Allentown, Pennsylvania, 18104
GSK Investigational Site
Dallas, Texas, 75235
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Miami, Florida, 33136-1002
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Roanoke, Virginia, 24018
Israel2 sites
GSK Investigational Site
Ramat Gan, 52621
GSK Investigational Site
Zrifin, 70300
About this study
Official title: A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients With Treatment- Naive Breast Cancer
This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.
- Conditions
- Neoplasms, Breast
- Being tested
- lapatinib
- Keywords
- lapatinib, breast cancer, treatment-naive
- 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
GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route
| Study group | Role | What they receive |
|---|---|---|
| Lapatinib receivers | Experimental | Subjects with treatment-naïve breast tumors will be administered lapatinib 1500 mg once daily, 1000 mg once daily, or 500 mg twice daily for a minimum of 9 days and maximum of 15 days prior to surgical resection.. Receives: Drug: lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples.
biomarker analysis of tumor biopsies pre/post dose
Measured: subjects on study up to 15 days
Secondary outcomes (1)
Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors.
safety assessments of labs, hematology labs, Electrocardiogram, vital signs
Measured: subjects on study up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study start29 Jun 2004
- Primary completion9 Jan 2008
- Study completion9 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT00359190
- Sponsor's protocol ID
- EGF10027
- Status last verified
- Nov 2017
- First submitted
- 28 Jul 2006
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Spector NL, Robertson FC, Bacus S, Blackwell K, Smith DA, Glenn K, Cartee L, Harris J, Kimbrough CL, Gittelman M, Avisar E, Beitsch P, Koch KM. Lapatinib Plasma and Tumor Concentrations and Effects on HER Receptor Phosphorylation in Tumor. PLoS One. 2015 Nov 16;10(11):e0142845. doi: 10.1371/journal.pone.0142845. eCollection 2015.
PubMed 26571496
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients With Treatment- Naive Breast Cancer
- ClinicalTrials.gov ID
- NCT00359190
- Acronym / sponsor ID
- EGF10027
- Conditions
- Neoplasms, Breast
- Keywords
- lapatinib, breast cancer, treatment-naive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2004 (actual)
- Primary completion
- 9 Jan 2008 (actual)
- Study completion
- 9 Jan 2008 (actual)
- First posted
- 1 Aug 2006 (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 examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lapatinib receivers | Experimental | Drug: lapatinibSubjects with treatment-naïve breast tumors will be administered lapatinib 1500 mg once daily, 1000 mg once daily, or 500 mg twice daily for a minimum of 9 days and maximum of 15 days prior to surgical resection.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical labs are within acceptable ranges.
- A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
- At least 18 years of age.
- Females must meet certain criteria specified in protocol.
- Ability to swallow and retain oral medication.
Key exclusion criteria (8 listed)
- Female who is pregnant or lactating.
- Medically unfit by the doctor as a result of the medical interview or physicals.
- Received treatment of an investigational drug within 4 weeks of study start.
- Currently receiving treatment with prohibited meds listed in protocol.
- Had major surgery in previous 2 weeks.
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 |
|---|---|---|
| lapatinibGW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route | Drug | Lapatinib receivers |
Primary outcome
Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples.
Time frame: subjects on study up to 15 days
biomarker analysis of tumor biopsies pre/post dose
1 secondary outcome
Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors.
Time frame: subjects on study up to 15 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 13 Nov 2017.
- Derived from this study: PubMed 26571496Spector NL, Robertson FC, Bacus S, Blackwell K, Smith DA, Glenn K, Cartee L, Harris J, Kimbrough CL, Gittelman M, Avisar E, Beitsch P, Koch KM. Lapatinib Plasma and Tumor Concentrations and Effects on HER Receptor Phosphorylation in Tumor. PLoS One. 2015 Nov 16;10(11):e0142845. doi: 10.1371/journal.pone.0142845. eCollection 2015.
- Results for study EGF10027 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
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lapatinib in people with Neoplasms, Breast, run by GlaxoSmithKline at 10 sites in 2 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 6 inclusion and 8 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 13 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 10 sites in United States, Israel. 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?
Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples. (time frame: subjects on study up to 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00359190, which also lists 1 linked publication.
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 13 Nov 2017.