Last updated: 11/03/2018 13:46:44
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Exploratory lapatinib (positron emission tomography) PET study in subjects with breast cancer

GSK study ID
112867
See study documents
Clinicaltrials.gov ID
NCT01290354
EudraCT ID
2009-009884-76
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Brain penetration of [11C]lapatinib

Timeframe: 8 days

Brain tumour penetration of [11C]lapatinib

Timeframe: 8 days

Secondary outcomes:

Safety as assessed by number of subjects with adverse events

Timeframe: 16-19 days

[11C]lapatinib uptake in non-brain tumour sites

Timeframe: 8 days

Interventions:
  • Drug: Lapatinib
  • Drug: [11C] lapatinib
    • Enrollment:
    10
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Cancer
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    September 2011 to March 2013
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Female, aged >/= 18 years old
    • Advanced or metastatic breast cancer with overexpression of HER2
    • Subjects with brain metastases who have undergone prior CNS surgery
    • Significant brain abnormalities, neurological disorder, psychiatric disorder or previous brain damage
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, W6 8RF
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, EC1A 7BE
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    London, London, United Kingdom, W12 0NN
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-18-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 112867 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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