Last updated: 02/04/2020 16:40:05
PGx308, PGx309, PGx310 and PGx382 evaluation of efficacy and safety endpoints in pazopanib-treated renal cell carcinoma (RCC) patients in studies VEG102616, VEG105192, and VEG107769
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: PGx308, PGx309, PGx310 and PGx382 evaluation of efficacy and safety endpoints in pazopanib-treated renal cell carcinoma (RCC) patients in studies VEG102616, VEG105192, and VEG107769
Trial description: This analysis uses pooled data from clinical studies: VEG102616, VEG105192, and VEG107769. The objective of this analysis is to identify germline genetic markers associated with efficacy and safety endpoints in pazopanib treated patients with renal cell carcinoma (RCC).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Evaluate genetic associations with 3) Response rate
Timeframe: N/A
Evaluate genetic associations with 6) Hand-foot syndrome
Timeframe: N/A
Evaluate genetic associations with 5) Fatigue
Timeframe: N/A
Evaluate genetic associations with 1) Progression free survival
Timeframe: N/A
Evaluate genetic associations with 2) Overall survival
Timeframe: N/A
Evaluate genetic associations with 4) Blood pressure
Timeframe: N/A
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
2012-21-08
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
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
Cancer, Neoplasms
Product
pazopanib
Collaborators
Not applicable
Study date(s)
February 2010 to August 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Patients who provided written informed consent for PGx research when they enrolled in the clinical study and did not withdraw consent prior to PGx experiment
- Patients who provided a blood sample for genotyping
- Patients whose percentage of markers successfully genotyped for the subject is less than 80%, and it can not be concluded that the available genotypes for the subject are likely to be accurate and of high quality
- Patients whose genotypes for their sex chromosomes do not agree with their reported gender
Inclusion and exclusion criteria
Inclusion criteria:
- Patients who provided written informed consent for PGx research when they enrolled in the clinical study and did not withdraw consent prior to PGx experiment
- Patients who provided a blood sample for genotyping
- Patients who successfully genotyped for at least one of the genetic markers under study
Exclusion criteria:
- Patients whose percentage of markers successfully genotyped for the subject is less than 80%, and it can not be concluded that the available genotypes for the subject are likely to be accurate and of high quality
- Patients whose genotypes for their sex chromosomes do not agree with their reported gender
- Patients who were identified as unintentional duplicates on a genetic level
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Study complete
Actual primary completion date
2012-21-08
Actual study completion date
2012-21-08
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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