Exploratory Lapatinib (Positron Emission Tomography) PET Study in Subjects With Breast Cancer

• Status: Completed
• Trial end date: 2013-03-18
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lapatinib

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.