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

NCT03075995 | Unknown DMC

• 1 other identifier: SYSU002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

lapatinib; steady state plasma concentration; high-fat breakfast

Outcome Measures

Primary Outcomes (1)

• the Best Mode for Takeing Lapatinib

  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

  20 days

Study Arms (1)

lapatinib administered with hight-fat breakfast

EXPERIMENTAL

Other: hight-fat breakfast

Interventions

hight-fat breakfast OTHER

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.

lapatinib administered with hight-fat breakfast

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advance breast cancer with her2 positive
• The patients are ready to use or using lapatinib for tumor treatment, and plans to keep the treatment for at least a month
• The ECOG score is 0 to 2
• hemoglobin≥ 9 gm/dL
• serum albumin concentration is normal
• ALT / AST / bilirubin\<1.5UL
• creatinine clearance rate≥ 40 mL/min
• signed ICF

You may not qualify if:

• Pregnancy or Pregnancy
• Stomach absorption dysfunction
• Difficulty in taking fatty food
• Severe heart disease or medical condition

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fei Xu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Xu, MD

CONTACT

13711277870; xufei@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Senior Doctor

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 9, 2017
• Study Start: April 12, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2019
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)