Clinical Trials /

To Discuss the Best Mode for Taking Lapatinib Under the Influence of the Diet

NCT03075995

Description:

Food can make a big difference on the bioavailability of lapatinib in breast cancer patients,and fatty food can increase the lapatinib bioavailability.By examine the steady blood drug concentration in the same individual at different treatment mode for lapatinib,emptiness or taken with fatty food,discuss the best mode of taking lapatinib with fatty food.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: To Discuss the Best Mode for Taking Lapatinib Under the Influence of the Diet
  • Official Title: To Discuss the Best Mode for Taking Lapatinib Under the Influence of the Diet

Clinical Trial IDs

  • ORG STUDY ID: SYSU002
  • NCT ID: NCT03075995

Conditions

  • Breast Cancer

Purpose

Food can make a big difference on the bioavailability of lapatinib in breast cancer patients,and fatty food can increase the lapatinib bioavailability.By examine the steady blood drug concentration in the same individual at different treatment mode for lapatinib,emptiness or taken with fatty food,discuss the best mode of taking lapatinib with fatty food.

Detailed Description

      Metastatic breast cancer is the leading cause of cancer-related death among women worldwide
      ,those overexpress the HER2 are associated with a higher risk. Lapatinib is approved for use
      to treat advanced metastatic breast cancer. The pharmacokinetic parameters of lapatinib have
      been characterized previously.It can reach steady state concentration after 6 or 7 days oral
      dosing, but the bioavailability is very different between different patients. The effect of
      food on lapatinib pharmacokinetics in humans was first examined in 19 healthy participants
      who were given single 100-mg doses with a high-fat breakfast. Food caused a 60% increase in
      the relative bioavailability of lapatinib.Another test showed that the bioavailability of
      lapatinib was 3 times more in low-fat diet than in emptiness.

      Some investigators think that it can change the mode for taking lapatinib with food or
      without food to enhance the absorption.It may decrease the oral dose but the lapatinib can
      reach the same steady state concentration,so it can achieve maximum economic benefits.

      By continuous change for lapatinib and fat diet, The change of lapatinib pharmacokinetic is
      lack of discussion. If the adverse reactions increase since the absorption of lapatinib
      increase, the existing research data are still lacking.

      The trial By examine the steady blood drug concentration in the same individual at different
      treatment mode for lapatinib, emptiness or taken with fatty food, discuss the best mode of
      taking lapatinib with fatty food.
    

Trial Arms

NameTypeDescriptionInterventions
lapatinib administered with hight-fat breakfastExperimental

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Advance breast cancer with her2 positive
    
              2. The patients are ready to use or using lapatinib for tumor treatment, and plans to
                 keep the treatment for at least a month
    
              3. The ECOG score is 0 to 2
    
              4. hemoglobin≥ 9 gm/dL
    
              5. serum albumin concentration is normal
    
              6. ALT / AST / bilirubin<1.5UL
    
              7. creatinine clearance rate≥ 40 mL/min
    
              8. signed ICF
    
            Exclusion Criteria:
    
              1. Pregnancy or Pregnancy
    
              2. Stomach absorption dysfunction
    
              3. Difficulty in taking fatty food
    
              4. Severe heart disease or medical condition
          
    Maximum Eligible Age:65 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:the Best Mode for Takeing Lapatinib
    Time Frame:20 days
    Safety Issue:
    Description:by examined the steady state plasa concentration of Lapatinib ,determine which is the best way to take lapatinib,with high-fat breakfast or on an empty stomach

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Sun Yat-sen University

    Trial Keywords

    • lapatinib
    • steady state plasma concentration
    • high-fat breakfast

    Last Updated