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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


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Trial Information

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


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®.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Occurrence of adverse events after Tykerb® administration

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Korea: Korea Food & Drug Administration

Study ID:

112477

NCT ID:

NCT00975988

Start Date:

January 2010

Completion Date:

October 2013

Related Keywords:

  • Cancer
  • Tykerb®
  • PMS (post-marketing surveillance)

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