Last updated: 11/03/2018 19:32:00
PGx6202: Genetic Evaluation of Efficacy and Safety Endpoints in Patients with Ovarian Cancer in VEG110655/VEG114012
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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