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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821054
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms, Breast Drug: Lapatinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : March 6, 2009
Actual Primary Completion Date : March 22, 2011
Actual Study Completion Date : March 22, 2011

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: TYKERB - US; TYVERB - UK




Primary Outcome Measures :
  1. Protocol specified pharmacokinetic parameters [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Safety and tolerability as assessed by evaluation of adverse events (AEs), changes in laboratory values, and vital signs [ Time Frame: 3 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821054


Locations
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United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14263
United States, South Carolina
GSK Investigational Site
Greenville, South Carolina, United States, 29605
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2W 1T8
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00821054    
Other Study ID Numbers: 111582
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Keywords provided by GlaxoSmithKline:
Phase I Food Effect
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lapatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action