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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

Phase 1
18 Years
65 Years
Not Enrolling
Metastatic ErbB2, Neoplasms, Breast, Breast Cancer

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Trial Information

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

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:

- 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, and through the Week 10

- 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.

- Provided written informed consent.

- Adequate bone marrow function.

- Clinical lab results with ranges as stated per protocol.

- Potassium and magnesium within the normal range of institutional values. [Serum
potassium or magnesium values that fall outside the normal range may be repeated once
at the discretion of the investigator, provided they are considered to be clinically

- Has a left ventricular ejection fraction (LVEF) within the normal institutional range
based on ECHO or MUGA.

- Life expectancy of at least 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 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 CTCAE Grade 2 or greater hypercalcemia as per protocol.

- Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to digoxin
or 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 currently receiving amiodarone or has received amiodarone in the six months prior
to screening.

- Is receiving any prohibited medication within the timeframe indicated on the
prohibited medication list as per protocol.

- Has physiological, familial, sociological, or geographical conditions that do not
permit compliance with the protocol.

- Subjects with certain disorders involving heart failure associated with preserved
left ventricular ejection fraction such as restrictive cardiomyopathy, constrictive
pericarditis, amyloid heart disease, acute cor pulmonale, idiopathic hypertrophic
subaortic stenosis, or any other cardiac condition that would preclude the
administration of digoxin.

- Has a clinically significant electrocardiogram (ECG) abnormality, including but not
limited to sinus node disease, pre-existing incomplete AV block, and Wolff
Parkinson-White Syndrome.

- Has inadequate venous access for protocol-related blood draws.

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To characterize the effect of repeat oral dose lapatinib treatment on the pharmacokinetics of a single oral dose of digoxin in adult subjects with metastatic ErbB2 positive breast cancer.

Outcome Time Frame:

10 days

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

December 2009

Related Keywords:

  • Metastatic ErbB2
  • Neoplasms, Breast
  • Breast Cancer
  • lapatinib
  • Metastatic ErbB2 positive breast cancer
  • digoxin
  • Breast Neoplasms
  • Neoplasms



GSK Investigational SiteAlbuquerque, New Mexico  87109