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COMPLETEDPHASE1

Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive Breast Cancer

An Open-Label, Two-Part, Single Sequence Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally Administered Digoxin in Subjects With Metastatic ErbB2 Positive Breast Cancer

NCT00650910•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a two part study looking at the effect of lapatinib on concentrations of digoxin in the blood when both drugs are dosed together in Part 1; and looking at the safety and antitumor effect of lapatinib when used together with possible additional anticancer therapy as chosen at the doctor's discretion.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Metastatic, histologically confirmed breast cancer that overexpresses ErbB2 (3+ by IHC, FISH, or CISH positive).
•Is at least 18 years of age and not greater than 65 years of age.
•Is male or female.
•A female is eligible to enter and participate in the study if she is of:
•\- Non-childbearing potential (i.e. physiologically incapable of becoming pregnant), including any female who:
•Has had a hysterectomy
•Has had a bilateral oophorectomy (ovariectomy)
•Has had a bilateral tubal ligation, or
•Is post-menopausal (a demonstration of total cessation of menses for ≥ 1 year) or
•\- Childbearing potential, has a negative serum pregnancy test at Screening and agrees to one of the following:
+23 more criteria

Exclusion Criteria

•Is pregnant or lactating.
•Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the stomach or small bowel.

Locations (4)

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Seodaemun-gu, Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

Key Dates

Start Date

April 23, 2008

Primary Completion Date

July 10, 2009

Completion Date

July 10, 2009

Last Updated

November 17, 2017

Enrollment

ACTUAL participants

Conditions

Neoplasms, Breast

Interventions

lapatinib

DRUG

Digoxin

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

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COMPLETEDPHASE3

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

NCT00490139

Neoplasms, Breast

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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 17, 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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Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive 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