To Discuss the Best Mode for Taking Lapatinib Under the I... | NCT03075995

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

NCT03075995

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Apr 14, 2017Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

hight-fat breakfast

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2017Actual

Primary Completion Date

Apr 1, 2018Estimated

Completion Date

Apr 1, 2019Estimated

First Submitted Date

Mar 2, 2017

First Submission Date that Met QC Criteria

Mar 5, 2017

First Posted Date

Mar 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2017

Last Update Posted Date

Apr 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xu fei, Associate Senior Doctor, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lapatinib administered with hight-fat breakfast	Experimental		Other: hight-fat breakfast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fei Xu, MD	Contact	13711277870		xufei@sysucc.org.cn

Overall Officials

Name	Affiliation	Role
Fei Xu, MD	Sun Yat-Sen University Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University Cancer Center	Recruiting	Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.