Regulatory TYKERB® Tablets PMS

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00975988
• Collaborator: (none)
• Enrollment: 750
• Locations: 2
• Duration (Months): 53.9
• Patients Per Site: 375
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: TYKERB® tablets

Detailed 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

Study Design

• Study Type: Observational
• Actual Enrollment: 750 participants
• Time Perspective: Prospective
• 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
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
TYKERB® tablets There is only one group. This group includes patients administrated TYKERB® tablets	Drug: TYKERB® tablets; Patients administrated TYKERB® tablets according to the prescribing information

Outcome Measures

Primary Outcome Measures

1. Occurrence of adverse events after TYKERB® tablets administration [12 months]

Secondary Outcome Measures

1. Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Seoul		Korea, Republic of	110-744
2	GSK Investigational Site	Seoul		Korea, Republic of	134-701

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00975988
• Other Study ID Numbers: 112477
• First Posted: Sep 14, 2009
• Last Update Posted: Oct 27, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by GlaxoSmithKline: PMS (post-marketing surveillance); TYKERB® tablets
• Additional relevant MeSH terms: Lapatinib

Study Results

No Results Posted as of Oct 27, 2014