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Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00359190•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (10)

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Durham, North Carolina, United States

GSK Investigational Site

Allentown, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Roanoke, Virginia, United States

GSK Investigational Site

Milwaukee, Wisconsin, United States

GSK Investigational Site

Ramat Gan, Israel

GSK Investigational Site

Zrifin, Israel

Key Dates

Start Date

June 29, 2004

Primary Completion Date

January 9, 2008

Completion Date

January 9, 2008

Last Updated

November 13, 2017

Enrollment

ACTUAL participants

Conditions

Neoplasms, Breast

Interventions

lapatinib

DRUG

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

NCT04915755

Neoplasms, Breast

View study

COMPLETEDPHASE3

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

NCT00490139

Neoplasms, Breast

View study

TERMINATEDPHASE3

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients