Last updated: 02/04/2020 15:40:09

PGx6557: Targeted Genotyping in lapatinib DILI positive re-challenge cases from EGF106708 and EGF106903

GSK study ID
117393
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: PGx6557: Targeted Genotyping in lapatinib DILI positive re-challenge cases from EGF106708 and EGF106903
Trial description: HLA markers (HLA-DRB1*07:01, HLA-DQA1*02:01, HLA-DQB1*02:01) have been confirmed to be associated with alanine aminotransferase (ALT) elevation in lapatinib-treated subjects. This PGx experiment aims to assess carriage of these pre-specified risk markers in lapatinib drug-induced liver injurty (DILI) positive re-challenge cases.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Assess carriage of these pre-specified risk markers in lapatinib drug-induced liver injurty (DILI) positive re-challenge cases.

Timeframe: N/A

Secondary outcomes:
Not applicable
Interventions:
  • Drug: lapatinib
    • Enrollment:
    0
    Primary completion date:
    2014-17-06
    Observational study model:
    Case-Only
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Breast
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    October 2012 to June 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Patients who provided written informed consent for PGx research when they enrolled in the clinical studies EGF106708 and EGF106903
    • Patients defined as a positive rechallenge DILI case by the GSK Hepatotoxicity panel
    • Patients that did not provide written informed consent for PGx research when they enrolled in the clinical studies EGF106708 and EGF106903
    • Patients that are not defined as a positive rechallenge DILI case by the GSK Hepatoxicity panel
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients who provided written informed consent for PGx research when they enrolled in the clinical studies EGF106708 and EGF106903
    • Patients defined as a positive rechallenge DILI case by the GSK Hepatotoxicity panel
    • Patients that had a PGx sample and genetic data available.
    Exclusion criteria:
    • Patients that did not provide written informed consent for PGx research when they enrolled in the clinical studies EGF106708 and EGF106903
    • Patients that are not defined as a positive rechallenge DILI case by the GSK Hepatoxicity panel
    • Patients that had an ALT elevation upon treatment with lapatinib but were not defined as a positive rechallenge DILI case by the GSK Hepatotoxicity panel
    • Patients that did not have a PGx sample or genetic data available.

    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
    Study complete
    Actual primary completion date
    2014-17-06
    Actual study completion date
    2014-17-06

    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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