Regulatory TYKERB® Tablets PMS

Cancer Clinical Trial

Official title:

An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of TYKERB® Tablets Administered in Korean Patients According to the Prescribing Information

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975988
• Other study ID #: 112477
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: October 23, 2014
• Start date: January 2010
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: MFDS(Ministry of Food and Drug Safety)
• Study type: Observational

Clinical Trial 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.

Description:

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® tablets will be administered with capecitabine for HER2 overexpressing advanced or metastatic breast cancer treatment or with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 as described the prescribing information of TYKERB® tablets

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• TYKERB® tablets
Patients administrated TYKERB® tablets according to the prescribing information

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events after TYKERB® tablets administration		12 months	No
Secondary	Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration		12 months	No