Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.

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Key information

Conditions

Neoplasms, Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Ramat Gan, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical labs are within acceptable ranges.
A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
At least 18 years of age.
Females must meet certain criteria specified in protocol.
Ability to swallow and retain oral medication.
Ability to follow and understand directions.

Exclusion criteria

Female who is pregnant or lactating.
Medically unfit by the doctor as a result of the medical interview or physicals.
Received treatment of an investigational drug within 4 weeks of study start.
Currently receiving treatment with prohibited meds listed in protocol.
Had major surgery in previous 2 weeks.
Had prior radiation therapy to the chest to treat this incidence of breast cancer.
Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
Has a malabsorption syndrome.

Treatment and study plan

Lapatinib

Drug

GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route

Primary outcomes

Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples.

Time frame: subjects on study up to 15 days

biomarker analysis of tumor biopsies pre/post dose

Secondary outcomes

Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors.

Time frame: subjects on study up to 15 days

safety assessments of labs, hematology labs, Electrocardiogram, vital signs

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients With Treatment- Naive Breast Cancer

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Aug 1, 2006
Registry last updated: Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed