NCT01290354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

September 12, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2013

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

January 27, 2011

Last Update Submit

November 8, 2017

Conditions

Cancer

Keywords

Brain penetrationpositron emission tomographyLapatinib

Outcome Measures

Primary Outcomes (2)

  • Brain penetration of [11C]lapatinib

    8 days

  • Brain tumour penetration of [11C]lapatinib

    8 days

Secondary Outcomes (2)

  • Safety as assessed by number of subjects with adverse events

    16-19 days

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

    8 days

Study Arms (1)

lapatinib

EXPERIMENTAL

unlabelled, administered orally

Drug: LapatinibDrug: [11C] lapatinib

Interventions

LapatinibDRUG

Unlabelled, administered orally

Also known as: Tykerb, Tyverb
lapatinib
[11C] lapatinibDRUG

Radiolabelled, administered intravenously

lapatinib

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

London, EC1A 7BE, United Kingdom

Location

GSK Investigational Site

London, W12 0NN, United Kingdom

Location

GSK Investigational Site

London, W6 8RF, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25977884DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Lapatinib

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 7, 2011

Study Start

September 12, 2011

Primary Completion

March 18, 2013

Study Completion

March 18, 2013

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

GB(3)