Regulatory Tykerb PMS

This study is currently recruiting participants.
Verified November 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00975988
First received: September 11, 2009
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Tykerb® administered in Korean patients according to the prescribing information


Condition Intervention
Cancer
Drug: tykerb

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Tykerb® Administered in Korean Patients According to the Prescribing Information

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of adverse events after Tykerb® administration [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of unexpected or serious adverse event after Tykerb® administration and effectiveness of Tykerb® [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: January 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients administrated Tykerb
There is only one group. This group includes patients administrated Tykerb
Drug: tykerb
patients administrated Tykerb according to the prescribing information

Detailed Description:

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Tykerb® administered in Korean patients according to the prescribing information

Tykerb® will be administered with capecitabine for ErbB2 overexpressing cancer treatment as described the prescribing information of Tykerb® or by physician's decision. Moreover, the data from the patients with Tykerb® monotherapy or with other combination than capecitabine will be also included if physicians in charge decide to treat with Tykerb®.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients administrated Tykerb at the site

Criteria

All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:

  • Subjects with indication in the prescribing information
  • Subjects administrated Tykerb® by physician's decision
  • Subjects with no contraindication according to the prescribing information
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975988

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Korea, Republic of
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 110-744
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 134-701
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00975988     History of Changes
Other Study ID Numbers: 112477
Study First Received: September 11, 2009
Last Updated: November 21, 2013
Health Authority: Korea: Korea Food & Drug Administration

Keywords provided by GlaxoSmithKline:
Tykerb®
PMS (post-marketing surveillance)

Additional relevant MeSH terms:
Lapatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014