Last updated: 03/05/2020 20:30:08
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.

PGx474 Investigation of immune mechanisms relating to lapatinib associated hepatotoxicity

GSK study ID
117268
Clinicaltrials.gov ID
Not applicable
EudraCT ID
2013-000572-15
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: PGx474 Investigation of immune mechanisms relating to lapatinib associated hepatotoxicity
Trial description: Lapatinib-induced hepatotxicity is strongly associated with the carriage of specific Class II HLA alleles. The aim of this investigation is to characterise the cellular immune mechanisms of this hepatotoxicity. Blood samples will be collected from selected subjects who participated previously in EGF105485 (TEACH: Lapatinib vesus placebo in women with early-stage HER2 overexpressing breast cancer). Subjects have been identified as hepatic SAE cases, treatment controls and disease controls. Ex vivo cell assays (T cell proliferation, CD4/CD8 expression and cytokine release profiles) will be conducted to characterise the T cell response to in vitro lapatinib re-challenge.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The overall objective is to determine the immune cell types and characteristics involved in sensitisation and lapatinib-induced hepatotoxicity by comparisons in case and control subjects

Timeframe: N/A

Secondary outcomes:
Not applicable
Interventions:
  • Other: no drug administration, collection of a single blood sample
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Control
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Breast
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    November 2013 to April 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Selected subjects from EGF105485 which have been identified as lapatinib-treated hepatic cases, lapatinib-treated controls and placebo treated disease controls
    • All other subjects from EGF105485
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Selected subjects from EGF105485 which have been identified as lapatinib-treated hepatic cases, lapatinib-treated controls and placebo treated disease controls
    Exclusion criteria:
    • All other subjects from EGF105485

    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
    2014-16-04

    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
    Visit website