Last updated: 11/03/2018 14:12:52
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 GSK Clinical Study Register is no longer maintained for this study.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.

Tykerb ALL

GSK study ID
113092
See study documents
Clinicaltrials.gov ID
NCT01332396
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: Drug Use Investigation for TYKERB tablet (All case investigation)
Trial description: Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Lapatinib
    • Enrollment:
    3000
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Cancer, Neoplasms
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    June 2009 to April 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Patients with HER2 overexpressing inoperable or recurrent breast cancer
    • Patients with hypersensitivity to lapatinib or any components
    • Pregnant women and women suspected of being pregnant
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with HER2 overexpressing inoperable or recurrent breast cancer
    Exclusion criteria:
    • Patients with hypersensitivity to lapatinib or any components
    • Pregnant women and women suspected of being pregnant

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    Not applicable

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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