NCT00359190

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2004

Typical duration for phase_1

Geographic Reach
2 countries

10 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

Study Start

First participant enrolled

June 29, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2008

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

3.5 years

First QC Date

July 28, 2006

Last Update Submit

November 8, 2017

Conditions

Neoplasms, Breast

Keywords

lapatinibbreast cancertreatment-naive

Outcome Measures

Primary Outcomes (1)

  • 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.

    biomarker analysis of tumor biopsies pre/post dose

    subjects on study up to 15 days

Secondary Outcomes (1)

  • 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.

    subjects on study up to 15 days

Study Arms (1)

Lapatinib receivers

EXPERIMENTAL

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

Interventions

lapatinibDRUG

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

Lapatinib receivers

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

GSK Investigational Site

Miami, Florida, 33136-1002, United States

Location

GSK Investigational Site

Durham, North Carolina, 27710, United States

Location

GSK Investigational Site

Allentown, Pennsylvania, 18104, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Dallas, Texas, 75235, United States

Location

GSK Investigational Site

Roanoke, Virginia, 24018, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

GSK Investigational Site

Ramat Gan, 52621, Israel

Location

GSK Investigational Site

Zrifin, 70300, Israel

Location

Related Publications (1)

  • Spector NL, Robertson FC, Bacus S, Blackwell K, Smith DA, Glenn K, Cartee L, Harris J, Kimbrough CL, Gittelman M, Avisar E, Beitsch P, Koch KM. Lapatinib Plasma and Tumor Concentrations and Effects on HER Receptor Phosphorylation in Tumor. PLoS One. 2015 Nov 16;10(11):e0142845. doi: 10.1371/journal.pone.0142845. eCollection 2015.

    PMID: 26571496DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 1, 2006

Study Start

June 29, 2004

Primary Completion

January 9, 2008

Study Completion

January 9, 2008

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

US(8)IL(2)