Last updated: 11/03/2018 12:59:43
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Regulatory TYKERB® tablets PMS

GSK study ID
112477
See study documents
Clinicaltrials.gov ID
NCT00975988
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial 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® is a registered trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of adverse events after TYKERB® tablets administration

Timeframe: 12 months

Secondary outcomes:

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

Timeframe: 12 months

Interventions:
  • Drug: TYKERB® tablets
    • Enrollment:
    750
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Cancer
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    January 2010 to July 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    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
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 110-744
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-29-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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