Exploratory Lapatinib (Positron Emission Tomography) PET Study in Subjects With Breast Cancer
NCT ID: NCT01290354
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2011-09-12
2013-03-18
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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lapatinib
unlabelled, administered orally
Lapatinib
Unlabelled, administered orally
[11C] lapatinib
Radiolabelled, administered intravenously
Interventions
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Lapatinib
Unlabelled, administered orally
[11C] lapatinib
Radiolabelled, administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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112867
Identifier Type: -
Identifier Source: org_study_id