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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2013-20-05
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)
No location data available.
Study documents
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
2013-20-05
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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