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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

Phase 1
18 Years
65 Years
Not Enrolling
Neoplasms, Breast, Advanced or Metastatic ErbB2-overexpressing Breast Cancer

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Trial Information

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

Protocol specified pharmacokinetic parameters

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Canada: Health Canada

Study ID:




Start Date:

March 2009

Completion Date:

March 2011

Related Keywords:

  • Neoplasms, Breast
  • Advanced or Metastatic ErbB2-overexpressing Breast Cancer
  • Phase I Food Effect
  • Breast Neoplasms
  • Neoplasms



GSK Investigational Site Columbia, South Carolina  29210
GSK Investigational Site New York, New York  10021