NCT00975988

Brief Summary

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is a registered trademark of the GlaxoSmithKline group of companies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

4.5 years

First QC Date

September 11, 2009

Last Update Submit

October 23, 2014

Conditions

Cancer

Keywords

PMS (post-marketing surveillance)TYKERB® tablets

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events after TYKERB® tablets administration

    12 months

Secondary Outcomes (1)

  • Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration

    12 months

Study Arms (1)

TYKERB® tablets

There is only one group. This group includes patients administrated TYKERB® tablets

Drug: TYKERB® tablets

Interventions

TYKERB® tabletsDRUG

Patients administrated TYKERB® tablets according to the prescribing information

TYKERB® tablets

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients administrated TYKERB® tablets at the site

All subjects must satisfy the following criteria at PMS entry according to MFDS PMS regulation: * Subjects with indication in the locally approved prescribing information * Subjects with no contraindication according to the prescribing information

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 134-701, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Lapatinib

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

January 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

KR(2)