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

NCT ID: NCT00359190

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-29

Study Completion Date

2008-01-09

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms, Breast

Keywords

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lapatinib breast cancer treatment-naive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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..

Group Type EXPERIMENTAL

lapatinib

Intervention Type DRUG

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

Interventions

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lapatinib

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Durham, North Carolina, United States

Site Status

GSK Investigational Site

Allentown, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Roanoke, Virginia, United States

Site Status

GSK Investigational Site

Milwaukee, Wisconsin, United States

Site Status

GSK Investigational Site

Ramat Gan, , Israel

Site Status

GSK Investigational Site

Zrifin, , Israel

Site Status

Countries

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United States Israel

References

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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.

Reference Type DERIVED
PMID: 26571496 (View on PubMed)

Other Identifiers

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EGF10027

Identifier Type: -

Identifier Source: org_study_id