Last updated: 11/03/2018 19:32:00

PGx6202: Genetic Evaluation of Efficacy and Safety Endpoints in Patients with Ovarian Cancer in VEG110655/VEG114012

GSK study ID
116747
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: PGx6202: Genetic Evaluation of Efficacy and Safety Endpoints in Patients with Ovarian Cancer in VEG110655/VEG114012
Trial description: Pazopanib is an oral angiogenesis inhibitor targeting vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, platelet-derived growth factor receptors, and the stem cell factor receptor, c-Kit. AGO-OVAR16 (VEG110655) is a phase III study to evaluate the efficacy and safety of pazopanib compared to placebo (1:1) in women with non-bulky, FIGO Stage II-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not progressed after first line chemotherapy. VEG114012 is a Phase II study similar in design to VEG110655 but conducted to evaluate safety and efficacy outcomes of pazopanib monotherapy and placebo in an Asian population. The purpose of this PGx analysis is to explore associations between genetic variants and clinical efficacy and safety endpoints in pazopanib-treated subjects within these two clinical studies using both genome wide association study (GWAS) and candidate gene analyses.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Efficacy endpoints in pazopanib-treated subjects in studies VEG110655 and VEG114012

Timeframe: N/A

Secondary outcomes:

Safety endpoints in pazopanib-treated subjects in studies VEG110655 and VEG114012

Timeframe: N/A

Interventions:
  • Other: placebo
  • Drug: pazopanib
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Ovarian
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    June 2012 to April 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Women who provided written informed consent and a DNA sample for pharmacogenetic research
    • Women who had clinical outcome and genotyping data available in clinical studies VEG110655 and VEG114012
    • Subjects with arrays where genotyping failed, as identified in the manufacturers genotype calling software and following manufacturer’s guidelines
    • Subjects with low (~ <80%) call rate
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Women who provided written informed consent and a DNA sample for pharmacogenetic research
    • Women who had clinical outcome and genotyping data available in clinical studies VEG110655 and VEG114012
    Exclusion criteria:
    • Subjects with arrays where genotyping failed, as identified in the manufacturers genotype calling software and following manufacturer’s guidelines
    • Subjects with low (~ <80%) call rate
    • Subjects for whom gender inferred from sex chromosome genotypes cannot be reconciled with gender recorded on the case report form
    • Women who did not provide written informed consent and/or a DNA sample for pharmacogenetic research, or did not have clinical outcome or genotyping data available in clinical studies VEG110655 and VEG114012

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website