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

November 8, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • GSK Investigational Site
      • Zrifin, Israel, 70300
        • GSK Investigational Site
  • United States
    • Florida
      • Miami, Florida, United States, 33136-1002
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • GSK Investigational Site
    • Virginia
      • Roanoke, Virginia, United States, 24018
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lapatinib receivers
Subjects with treatment-naïve breast tumors will be administered lapatinib 1500 mg once daily, 1000 mg once daily, or 500 mg twice daily for a minimum of 9 days and maximum of 15 days prior to surgical resection..
Drug: lapatinib
GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
subjects on study up to 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
subjects on study up to 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2004

Primary Completion (Actual)

January 9, 2008

Study Completion (Actual)

January 9, 2008

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 28, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGF10027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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