- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01290354
Exploratory Lapatinib (Positron Emission Tomography) PET Study in Subjects With Breast Cancer
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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, W12 0NN
- GSK Investigational Site
-
London, United Kingdom, EC1A 7BE
- GSK Investigational Site
-
London, United Kingdom, W6 8RF
- GSK Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: lapatinib
unlabelled, administered orally
|
Unlabelled, administered orally
Other Names:
Radiolabelled, administered intravenously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brain penetration of [11C]lapatinib
Time Frame: 8 days
|
8 days
|
Brain tumour penetration of [11C]lapatinib
Time Frame: 8 days
|
8 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety as assessed by number of subjects with adverse events
Time Frame: 16-19 days
|
16-19 days
|
[11C]lapatinib uptake in non-brain tumour sites
Time Frame: 8 days
|
8 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112867
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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