Last updated: 02/03/2020 19:20:33
PGx420: Genetic Evaluation(exploratory and confirmatory) of efficacy and safety endpoints in pazopanib(GW786034)/sunitinib-treated patients with renal cell carcinoma (VEG108844,VEG113078)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: PGx420: Genetic Evaluation(exploratory and confirmatory) of efficacy and safety endpoints in pazopanib(GW786034)/sunitinib-treated patients with renal cell carcinoma (VEG108844,VEG113078)
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. Previous exploratory pharmacogenetic (PGx) studies in pazopanib-treated patients with advanced renal cell carcinoma (RCC) based on data from clinical studies VEG102616, VEG105192, and VEG107769 suggested that germline genetic markers may be associated with efficacy or safety endpoints. The purpose of this PGx analysis is to confirm the previously identified associations between functional markers in candidate genes and the following efficacy or safety endpoints in pazopanib-treated patients with advanced RCC: progression-free survival (PFS), objective response rate (ORR), overall survival (OS), blood pressure (BP), alanine aminotransferase (ALT), total bilirubin (TBL), hand-foot syndrome (HFS), and diarrhoea, using data from clinical studies VEG108844 and VEG113078. VEG108844 is a randomized (1:1), open label, Phase III study to evaluate the efficacy and safety of pazopanib compared to sunitinib in subjects with advanced RCC who have received no prior systemic therapy. VEG113078 is a substudy of VEG108844 in Asian subjects with advanced or metastatic RCC. There are 927 and 183 patients enrolled in VEG108844 and VEG113078 studies respectively. The potential associations between these genetic markers and sunitinib efficacy or safety endpoints will be explored for comparison purpose. Subjects from VEG108844 and VEG113078 who consented and provided a DNA sample will be included in this genetic investigation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Determine if genetic markers are associated with efficacy or safety endpoints in pazopanib-treated patients with RCC in studies VEG108844 and VEG113078
Timeframe: N/A (As this a retrospective genetics study of previously acquired blood samples, there is no timing for this outcome)
Secondary outcomes:
Explore whether the genetic markers are associated with efficacy or safety endpoints in sunitinib- treated patients with RCC in studies VEG108844 and VEG113078
Timeframe: N/A (As this a retrospective genetics study of previously acquired blood samples, there is no timing for this outcome)
Interventions:
Drug: pazopanib
Drug: sunitinib
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2013-31-10
Time perspective:
Retrospective
Clinical publications:
Motzer R, Johnson T, Choueiri T, et al. Hyperbilirubinemia in pazopanib- or sunitinib- treated patients in COMPARZ is associated with UGT1A1 polymorphisms. Ann Oncol. 2013;24(11):2927-2928
Xu C-F, Johnson T, Garcia-Donas J, et al .IL8 polymorphisms and Overall Survival in Pazopanib- or Sunitinib-treated Patients with Advanced Renal Cell Carcinoma.Br J Cancer.2015;112 Suppl:1190-8
Medical condition
Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
September 2011 to October 2013
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, had clinical outcome and genotyping data available in VEG108844 and VEG113078
- Subject may be removed from analysis if:
- 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;
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who provided written informed consent and a DNA sample for pharmacogenetic research, had clinical outcome and genotyping data available in VEG108844 and VEG113078
Exclusion criteria:
- Subject may be removed from analysis if:
- 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;
- the genotypes for his/her sex chromosome genotypes do not agree with the reported gender;
- potential sample contamination is detected
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
2013-31-10
Actual study completion date
2013-31-10
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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