Investigation of immune mechanisms relating to lapatinibassociated hepatotoxicity: ex vivo T cell biology investigationrelating to lapatinib induced liver adverse events using PBMCsfrom patients selected from EGF105485 (TEACH). - PGx474 Investigation of immune mechanisms relating

GlaxoSmithKline Research & Development Ltd0 sites75 target enrollmentJune 18, 2013

DrugsTyverb

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 75
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 18, 2013

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

GlaxoSmithKline Research & Development Ltd

Eligibility Criteria

Inclusion Criteria

•Note that treatment and disease controls will only be collected if their respective, matched case is able to consent and provide a blood sample.
•The four groups of subjects will be selected as follows: i) lapatinib\-treated subjects who had a previously reported and documented hepatic serious adverse event (cases), ii) selected lapatinibtreated subjects who did not experience liver adverse events, with normal liver chemistries at baseline and throughout treatment (treatment controls) and iii) placebo treated subjects who had normal liver chemistries at baseline and throughout treatment (disease controls). Subjects for the two control groups will be matched with the casesbased on their HLA\-DQA1\*02:01/DRB1\*07:01 allele carriage, ethnicity, study site (where possible) and country.
•In addition, HLA\-DRB1\*07:01 and –DQA1\*02:01 alleles are inherited together in 99\.8% of the study population and genetic investigation has not determined which of the two alleles is causative for hepatotoxicity. However, three EGF105485 (TEACH) subjects have been identified with a rare mismatch of inheriting only one of these highly correlated alleles: HLA\-DRB1\*07:01 (1 subject, lapatinib treatment) or HLADQA1\* 02:01 (2 subjects, lapatinib or placebo treatment). These three subjects were characterised as controls and reside in North America. Whole blood samples will be collected to enable comparison of T cell activation following lapatinib challenge ex vivo.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 56
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 19