Last updated: 11/03/2018 20:21:08

PGx6652: Genetic Evaluation of Pazopanib –Related Hepatotoxicity

GSK study ID
117365
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: PGx6652: Genetic Evaluation of Pazopanib –Related Hepatotoxicity
Trial description: Pazopanib, an oral angiogenesis inhibitor, is approved for the treatment of advanced renal cell carcinoma (RCC) and soft tissue sarcoma (STS). Elevations in serum alanine aminotransferase (ALT) were observed in pazopanib clinical studies. Concurrent elevations of ALT and bilirubin without alkaline phosphatase elevation, conditions which may be associated with severe liver injury, were rare (~1%). Using both candidate gene and genome-wide approaches, this exploratory phamacogenetic (PGx) analysis will evaluate associations between genetic variants and hepatotoxicity in pazopanib-treated subjects with cancer.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Candidate gene analysis will test associations between candidate genetic variants and concurrent ALT (>3xULN) and bilirubin (>2xULN) elevations in pazopanib-treated case subjects (N=32) vs. race/ethnicity matched controls (N=70) from 16 clinical studies

Timeframe: N/A

Secondary outcomes:

GWAS and HLA analyses for on-treatment ALT elevation will be conducted using data from pazopanib-treated subjects from eight clinical studies (N=1225 for GWAS, and N=1228 for HLA analysis).

Timeframe: N/A

Interventions:
  • Drug: Pazopanib monotherapy and combination therapy for the candidate gene analysis; pazopanib monotherapy for the GWAS and HLA analyses
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Cancer, Neoplasms
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    November 2012 to April 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Subjects who provided written informed consent and a DNA sample for pharmacogenetic research
    • Subjects who had clinical phenotypes and genotyping data available
    • Subjects where less than 80% of markers are successfully genotyped and if it cannot be concluded that the available genotypes for the subject are likely to be accurate and of high quality;
    • Subjects where the genotypes for his/her sex chromosome genotypes do not agree with the reported gender;
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who provided written informed consent and a DNA sample for pharmacogenetic research
    • Subjects who had clinical phenotypes and genotyping data available
    Exclusion criteria:
    • Subjects where less than 80% of markers are successfully genotyped and if it cannot be concluded that the available genotypes for the subject are likely to be accurate and of high quality;
    • Subjects where the genotypes for his/her sex chromosome genotypes do not agree with the reported gender;
    • Subjects where potential sample contamination is detected

    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
    Not applicable
    Actual study completion date
    2014-15-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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