Last updated: 11/03/2018 16:44:55
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.

Lapatinib Post Marketing Surveillance StudyLapatinib PMS

GSK study ID
114498
Clinicaltrials.gov ID
Not applicable
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: A post-marketing surveillance study of lapatinib ditosylate in the treatment of Filipino patients with Advanced or Metastatic Breast Cancer (MBC)
Trial description: The study is a regulatory mandated post marketing surveillance study for lapatinib ditosylate.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

adverse event reactions from patients receiving lapatinib

Timeframe: 12 months

Secondary outcomes:

none

Timeframe: none

Interventions:
  • Drug: Tykerb
    • Enrollment:
    3000
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Cancer, Neoplasms
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    February 2011 to September 2015
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    18 - 85 Year
    Accepts healthy volunteers
    none
    • 1. Adult patients (including elderly) with clinically diagnosed Advanced or Metastatic Breast Cancer (MBC),
    • 2. Patients must give written informed consent to take part in the study.
    • 1. Patients with known hypersensitivity to lapatinib ditosylate or any component of the preparation.
    • 2. Patients with Hepatic Impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than the three times the upper limit of normal range (ULN)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 1. Adult patients (including elderly) with clinically diagnosed Advanced or Metastatic Breast Cancer (MBC), 2. Patients must give written informed consent to take part in the study. 3. As per recommendation of lapatinib ditosylate prescribing information.
    Exclusion criteria:
    • 1. Patients with known hypersensitivity to lapatinib ditosylate or any component of the preparation. 2. Patients with Hepatic Impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than the three times the upper limit of normal range (ULN) 3. Patients with Cardiac dysfunction (left ventricular ejection fraction (LVEF) below the lower limits of the institutional range as measured by ECHO)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    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
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