Exploratory Lapatinib (Positron Emission Tomography) PET Study in Subjects With Breast Cancer
- Registration Number
- NCT01290354
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lapatinib Lapatinib unlabelled, administered orally lapatinib [11C] lapatinib unlabelled, administered orally
- Primary Outcome Measures
Name Time Method Brain penetration of [11C]lapatinib 8 days Brain tumour penetration of [11C]lapatinib 8 days
- Secondary Outcome Measures
Name Time Method Safety as assessed by number of subjects with adverse events 16-19 days [11C]lapatinib uptake in non-brain tumour sites 8 days
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom
GSK Investigational Site🇬🇧London, United Kingdom