CancerPhase 1NCT01290354
Exploratory Lapatinib (Positron Emission Tomography) PET Study in Subjects With Breast Cancer
A Phase 1 study testing Lapatinib and [11C] lapatinib in people with Cancer, run by GlaxoSmithKline at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to find out how much lapatinib can enter both normal brains and brains in which tumours secondary to breast cancer have developed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Lapatinib and [11C] lapatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 12 Sep 2011to 18 Mar 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged >/= 18 years old
- Advanced or metastatic breast cancer with overexpression of HER2
- Be able to provide written informed consent and comply with protocol requirements
- If of child-bearing potential, using adequate and medically acceptable contraception method
- Have an ECOG performance status of 0-2 and be in stable condition
- Able to lie still on the PET scanner for approx. 1.5-2 h
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- Adequate hepatic and renal function
- Patent ulnar artery or collateral arterial blood vessels
- If have CNS metastases, disease must be stable
- Subjects with CNS metastases should have at least a single 1 cm diameter lesion as shown on contrast MRI
Who cannot join
- Subjects with brain metastases who have undergone prior CNS surgery
- Significant brain abnormalities, neurological disorder, psychiatric disorder or previous brain damage
- Diabetes type I
- History of HIV, hepatitis B or hepatitis C infection
- Current alcohol and/or drug abuse
- Positive pregnancy test or lactation
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- Malabsorption syndrome or disease affecting gastrointestinal function that may affect intestinal absorption
- Requirement for additional concurrent anti-cancer therapy
- History of uncontrolled or symptomatic angina
- Concurrent treatment with an investigational agent or anti-cytotoxic therapy or use within 30 days or 5 half-lives
- Known hypersensitivity reaction of idiosyncrasy to drugs chemically related to lapatinib or its excipients
- Concurrent treatment with CYP3A4 inducers and inhibitors
- Unwillingness to refrain from consuming red wine, Seville oranges, grapefruit, pomelo, grapefruit hybrids and their juices from 7 days before Day 1 until collection of the final pharmacokinetic sample
- Known history of claustrophobia
- Known contraindications or likely risk of toxicity to gadlinium-based MRI contrast media
- Presence of cardiac pacemaker, other electronic device or ferromagnetic metal foreign bodies
- Any abnormality found on the MRI scan which, in the opinion of the investigator, may influence the outcome of the PET scans or affect the safety of the volunteer
- Acute or active hepatic or biliary disease
- Any medical condition or circumstance making the volunteer unsuitable for participation in the study.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
GSK Investigational Site
London, EC1A 7BE
GSK Investigational Site
London, W12 0NN
GSK Investigational Site
London, W6 8RF
About this study
Official title: An Open-label Positron Emission Tomography Study to Investigate and Quantify Brain and Tumour Penetration of [11C]Lapatinib in Subjects With HER2-overexpressing Breast Cancer
The purpose of this study is to find out how much lapatinib can enter both normal brains and brains in which tumours secondary to breast cancer have developed.
Read the detailed description
Lapatinib is an anti-cancer drug taken by mouth which inhibits the HER2 protein, overexpressed in some breast tumours. It is not known whether lapatinib passes through the blood-brain barrier, and, therefore, whether it can target secondary tumours in the brain. This study will investigate whether lapatinib does indeed enter the brain.
Subjects with HER2-overexpressing breast cancer, with and without brain metastases, will receive lapatinib tablets daily for 8 days. The subjects will also receive lapatinib with a small amount of radioactivity attached on the first and last days of dosing to investigate whether it is taken up by the brain, using positron emission tomography (PET) scans.
- Conditions
- Cancer
- Being tested
- Lapatinib, [11C] lapatinib
- Keywords
- Brain penetration, positron emission tomography, Lapatinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapatinibDrug
Also called Tykerb, Tyverb
Unlabelled, administered orally
[11C] lapatinibDrug
Radiolabelled, administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| lapatinib | Experimental | unlabelled, administered orally Receives: Drug: Lapatinib; Drug: [11C] lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain penetration of [11C]lapatinib
Measured: 8 days
Brain tumour penetration of [11C]lapatinib
Measured: 8 days
Secondary outcomes (2)
Safety as assessed by number of subjects with adverse events
Measured: 16-19 days
[11C]lapatinib uptake in non-brain tumour sites
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study start12 Sep 2011
- Primary completion18 Mar 2013
- Study completion18 Mar 2013
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 CancerStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT01290354
- Sponsor's protocol ID
- 112867
- Status last verified
- Nov 2017
- First submitted
- 27 Jan 2011
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Saleem A, Searle GE, Kenny LM, Huiban M, Kozlowski K, Waldman AD, Woodley L, Palmieri C, Lowdell C, Kaneko T, Murphy PS, Lau MR, Aboagye EO, Coombes RC. Lapatinib access into normal brain and brain metastases in patients with Her-2 overexpressing breast cancer. EJNMMI Res. 2015 Apr 30;5:30. doi: 10.1186/s13550-015-0103-5. eCollection 2015.
PubMed 25977884
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
- An Open-label Positron Emission Tomography Study to Investigate and Quantify Brain and Tumour Penetration of [11C]Lapatinib in Subjects With HER2-overexpressing Breast Cancer
- ClinicalTrials.gov ID
- NCT01290354
- Acronym / sponsor ID
- 112867
- Conditions
- Cancer
- Keywords
- Brain penetration, positron emission tomography, Lapatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2011 (actual)
- Primary completion
- 18 Mar 2013 (actual)
- Study completion
- 18 Mar 2013 (actual)
- First posted
- 7 Feb 2011 (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.
The purpose of this study is to find out how much lapatinib can enter both normal brains and brains in which tumours secondary to breast cancer have developed.
Detailed description
Lapatinib is an anti-cancer drug taken by mouth which inhibits the HER2 protein, overexpressed in some breast tumours. It is not known whether lapatinib passes through the blood-brain barrier, and, therefore, whether it can target secondary tumours in the brain. This study will investigate whether lapatinib does indeed enter the brain.
Subjects with HER2-overexpressing breast cancer, with and without brain metastases, will receive lapatinib tablets daily for 8 days. The subjects will also receive lapatinib with a small amount of radioactivity attached on the first and last days of dosing to investigate whether it is taken up by the brain, using positron emission tomography (PET) scans.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lapatinib | Experimental | Drug: Lapatinib, Drug: [11C] lapatinibunlabelled, administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female, aged >/= 18 years old
- Advanced or metastatic breast cancer with overexpression of HER2
- Be able to provide written informed consent and comply with protocol requirements
- If of child-bearing potential, using adequate and medically acceptable contraception method
- Have an ECOG performance status of 0-2 and be in stable condition
Key exclusion criteria (19 listed)
- Subjects with brain metastases who have undergone prior CNS surgery
- Significant brain abnormalities, neurological disorder, psychiatric disorder or previous brain damage
- Diabetes type I
- History of HIV, hepatitis B or hepatitis C infection
- Current alcohol and/or drug abuse
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 |
|---|---|---|
| LapatinibAlso: Tykerb, TyverbUnlabelled, administered orally | Drug | lapatinib |
| [11C] lapatinibRadiolabelled, administered intravenously | Drug | lapatinib |
Primary outcome
Brain penetration of [11C]lapatinib
Time frame: 8 days
Brain tumour penetration of [11C]lapatinib
Time frame: 8 days
2 secondary outcomes
Safety as assessed by number of subjects with adverse events
Time frame: 16-19 days
[11C]lapatinib uptake in non-brain tumour sites
Time frame: 8 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 25977884Saleem A, Searle GE, Kenny LM, Huiban M, Kozlowski K, Waldman AD, Woodley L, Palmieri C, Lowdell C, Kaneko T, Murphy PS, Lau MR, Aboagye EO, Coombes RC. Lapatinib access into normal brain and brain metastases in patients with Her-2 overexpressing breast cancer. EJNMMI Res. 2015 Apr 30;5:30. doi: 10.1186/s13550-015-0103-5. eCollection 2015.
- Results for study 112867 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lapatinib and [11C] lapatinib in people with Cancer, run by GlaxoSmithKline at 3 sites in United Kingdom.
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 10 inclusion and 19 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 3 sites in United Kingdom. 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?
Brain penetration of [11C]lapatinib (time frame: 8 days). The study lists 2 primary outcomes in all. 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 NCT01290354, 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.