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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

Tracking Information
First Submitted Date  ICMJE December 18, 2008
First Posted Date  ICMJE January 12, 2009
Last Update Posted Date November 13, 2017
Actual Study Start Date  ICMJE March 6, 2009
Actual Primary Completion Date March 22, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
Protocol specified pharmacokinetic parameters [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
Safety and tolerability as assessed by evaluation of adverse events (AEs), changes in laboratory values, and vital signs [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Neoplasms, Breast
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Period 1
    Treatment A, B or C
    Intervention: Drug: Lapatinib
  • Experimental: Period 2
    Treatment A, B or C
    Intervention: Drug: Lapatinib
  • Experimental: Period 3
    Treatment A, B or C
    Intervention: Drug: Lapatinib
Publications * Devriese LA, Koch KM, Mergui-Roelvink M, Matthys GM, Ma WW, Robidoux A, Stephenson JJ, Chu QS, Orford KW, Cartee L, Botbyl J, Arya N, Schellens JH. Effects of low-fat and high-fat meals on steady-state pharmacokinetics of lapatinib in patients with advanced solid tumours. Invest New Drugs. 2014 Jun;32(3):481-8. doi: 10.1007/s10637-013-0055-4. Epub 2013 Dec 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2017)
24
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2009)
18
Actual Study Completion Date  ICMJE March 22, 2011
Actual Primary Completion Date March 22, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Netherlands,   United States
Removed Location Countries Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT00821054
Other Study ID Numbers  ICMJE 111582
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP