Last updated: 01/31/2020 15:50:05

PGx421:Exploratory genetic evaluation of efficacy and safety endpoints in pazopanib-treated patients with soft tissue sarcoma in VEG110727

GSK study ID
116103
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: PGx421:Exploratory genetic evaluation of efficacy and safety endpoints in pazopanib-treated patients with soft tissue sarcoma in VEG110727
Trial description: This pharmacogenetic analysis uses data from clinical study VEG110727. The objective is to identify germline genetic markers in candidate genes associated with efficacy and safety endpoints in pazopanib treated subjects with soft tissue sarcoma.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Evaluate associations of germline genetic markers with 1) progression free survival (PFS), 2) overall survival (OS).

Timeframe: N/A

Secondary outcomes:

Evaluate associations of germline genetic markers with 1) alanine aminotransferase (ALT), 2) total bilirubin (TBL), 3) hand-foot syndrome (HFS), 4) diarrhoea, and 5) blood pressure change

Timeframe: N/A

Interventions:
  • Drug: Treatment with pazopanib in clinical study VEG110727
    • Enrollment:
    0
    Primary completion date:
    2013-20-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Sarcoma, Soft tissue
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    November 2011 to May 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Provided written informed consent for PGx research when they enrolled in the clinical study and did not withdraw consent prior to PGx experiment
    • Provided a blood sample for genotyping
    • Percentage of markers successfully genotyped for a subject is less than 80%, and it can not be concluded that the available genotypes for the subject are accurate and of high quality.
    • Subjects' genotypes for their sex chromosomes do not agree with their reported gender.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Provided written informed consent for PGx research when they enrolled in the clinical study and did not withdraw consent prior to PGx experiment
    • Provided a blood sample for genotyping
    • Successfully genotyped for at least one of the genetic markers under study
    • Valid phenotype data
    Exclusion criteria:
    • Percentage of markers successfully genotyped for a subject is less than 80%, and it can not be concluded that the available genotypes for the subject are accurate and of high quality.
    • Subjects' genotypes for their sex chromosomes do not agree with their reported gender.
    • Subjects identified (genetically) as unintentional duplicates

    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
    2013-20-05
    Actual study completion date
    2013-20-05

    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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