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 GSK Clinical Study Register is no longer maintained for this study.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
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
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
Observational study model:
Not applicable
Primary completion date:
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
GSK Investigational Site
London, United Kingdom, EC1A 7BE
Status
Terminated/Withdrawn
Location
GSK Investigational Site
London, London, United Kingdom, W12 0NN
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
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
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Additional information
Results for study 112867 can be found on the GSK Clinical Study Register.
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