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 GSK Clinical Study Register is no longer maintained for this study.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
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
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
Observational study model:
Case-Control
Primary completion date:
Not applicable
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)
No location data available.
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