Clinical trial NCT03075995: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: lapatinib
steady state plasma concentration
high-fat breakfast
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: It's divided into two stages.For the first stage,the subjects take lapatinib on an empty stomach,the steady state plasa concentration is examined on the 9th and 10th days after lapatinib is administered.The second stage,the subject take lapatinib with hight-fat breakfast,the steady state plasa concentration is examined as the first stage.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: the Best Mode for Takeing Lapatinib
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Fei Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: