A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients

November 8, 2017 updated by: GlaxoSmithKline

An Open Label Study to Examine the Effects of Low-Fat and High-Fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients

This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of lapatinib administered after a high or low-fat meal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
        • GSK Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • GSK Investigational Site
  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • GSK Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • 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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Metastatic, histologically confirmed breast cancer that over-expresses 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:

    1. 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 in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory.
    2. Childbearing potential, has a negative serum pregnancy test at Screening and agrees to one of the following: double-barrier contraception (condom with spermicidal jelly, foam, suppository, or film; diaphragm with spermicide; or male condom and diaphragm); complete abstinence from sexual intercourse from two weeks prior to administration of the study drug, throughout the active study treatment period; vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
  • Is able to swallow and retain oral medication.
  • ECOG performance status 0 to 2.
  • Adequate bone marrow function.
  • Hemoglobin ≥ 9 gm/dL.
  • Absolute granulocyte count ≥1,500/mm3 (1.5 x 109/L).
  • Platelets ≥ 75,000/mm3 (75 x 109/L).
  • Calculated creatinine clearance (CrCl) ≥ 50 ml/min based on Cockcroft and Gault
  • Total bilirubin ≤ 1.5 X upper limit of normal of institutional values and INR ≤ 1.5.
  • Alanine transaminase (ALT) ≤ three times the upper limit of the institutional values or ≤ five times ULN with documented liver metastases.
  • Has a left ventricular ejection fraction (LVEF) within the normal institutional range based on ECHO or MUGA.
  • Life expectancy of ≥12 weeks
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • Is pregnant or lactating.
  • Has malabsorption syndrome, a disease affecting gastrointestinal function, or resection of the stomach or small bowel.
  • Has current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
  • Has evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease. Subjects with brain metastases treated by surgery and/or radiotherapy are eligible if neurologically stable and do not require steroids or anticonvulsants.
  • Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
  • Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product such as gefitinib [Iressa] and erlotinib [Tarceva].
  • Has received treatment with any investigational drug in the previous four weeks.
  • Has received chemotherapy, immunotherapy, biologic therapy or hormonal therapy for the treatment of cancer within the past 14 days, with the exception of mitomycin C which is restricted for the past six weeks.
  • Is receiving any prohibited medication within the timeframe indicated on the prohibited medication list for this study.
  • Has physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Has inadequate venous access for protocol-related blood draws.
  • Clinically significant electrocardiogram (ECG) abnormality.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Has consumed red wine, seville oranges, grapefruit or grapefruit juice and/or kumquats, pummelos, exotic citrus fruit (i.e. star fruit, bitter melon), grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Period 1
Treatment A, B or C
Drug: Lapatinib
Treatment A: one dose of 1250mg lapatinib 1 hour before starting a low-fat breakfast; Treatment B: one dose of 1250mg lapatinib 1 hour after finishing a low fat breakfast; or Treatment C: one dose of 1250mg lapatinib 1 hour after finishing a high-fat breakfast.
Other Names:
  • TYKERB - US; TYVERB - UK
EXPERIMENTAL: Period 2
Treatment A, B or C
Drug: Lapatinib
Treatment A: one dose of 1250mg lapatinib 1 hour before starting a low-fat breakfast; Treatment B: one dose of 1250mg lapatinib 1 hour after finishing a low fat breakfast; or Treatment C: one dose of 1250mg lapatinib 1 hour after finishing a high-fat breakfast.
Other Names:
  • TYKERB - US; TYVERB - UK
EXPERIMENTAL: Period 3
Treatment A, B or C
Drug: Lapatinib
Treatment A: one dose of 1250mg lapatinib 1 hour before starting a low-fat breakfast; Treatment B: one dose of 1250mg lapatinib 1 hour after finishing a low fat breakfast; or Treatment C: one dose of 1250mg lapatinib 1 hour after finishing a high-fat breakfast.
Other Names:
  • TYKERB - US; TYVERB - UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Protocol specified pharmacokinetic parameters
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability as assessed by evaluation of adverse events (AEs), changes in laboratory values, and vital signs
Time Frame: 3 weeks
3 weeks

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)

March 6, 2009

Primary Completion (ACTUAL)

March 22, 2011

Study Completion (ACTUAL)

March 22, 2011

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

January 8, 2009

First Posted (ESTIMATE)

January 12, 2009

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

  • 111582

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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