Last updated: 11/07/2018 08:28:43
PGx367 evaluation of ALT elevation in patients receiving pazopanib and statins in 11 pazopanib clinical studies (VEG102616, VEG105192, VEG107769, VEG10003, VEG10004, VEG10005, VEG10007, VEG20002, VEG20006, VEG104450, VEG105281)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: PGx367 evaluation of ALT elevation in patients receiving pazopanib and statins in 11 pazopanib clinical studies (VEG102616, VEG105192, VEG107769, VEG10003, VEG10004, VEG10005, VEG10007, VEG20002, VEG20006, VEG104450, VEG105281)
Trial description: This meta-analysis uses pooled data from subjects who received pazopanib monotherapy for cancer from eleven clinical studies: VEG10003, VEG10004, VEG10005, VEG10007, VEG20002, VEG20006, VEG102616, VEG104450, VEG105192, VEG105281, and VEG107769. The primary objective of this analysis is to evaluate the effect of concomitant use of statins and pazopanib on ALT elevation in subjects with cancer treated with pazopanib monotherapy. The secondary objective is to evaluate genetic associations with ALT elevation in subjects under concomitant use of statins and pazopanib.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Compare incidence rates of ALT elevation in pazopanib-treated subjects (monotherapy) with or without statin use, including comparisons based on specific statin subgroups
Timeframe: N/A ( this a retrospective analysis of previously collected data, there is no timing for this outcome)
Secondary outcomes:
Determine if genetic polymorphisms are factors associated with ALT elevation in subjects who received both pazopanib and statin
Timeframe: N/A (As this a retrospective analysis of previously collected data, there is no timing for this outcome)
Interventions:
Drug: Pazopanib without concurrent use of statins
Drug: Pazopanib with concurrent use of statins
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Xu C-F, Xue Z, Bing N, King K, McCann L, de Souza P, Goodman V, Spraggs C, Mooser V, Pandite L. Concomitant Use of Pazopanib and Simvastatin Increases the Risk of Transaminase Elevations in Patients With Cancer. [Ann Oncol]. 2012; Sep;23(9):2470-2471 .
Medical condition
Cancer, Neoplasms
Product
pazopanib
Collaborators
Not applicable
Study date(s)
May 2010 to September 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Subjects in the eleven clinical trials who received pazopanib monotherapy for the treatment of cancer and who had at least one post-baseline ALT measurement.
- For the PGx analyses, inclusion was further limited to subjects with PGx consent and valid genetic data.
- Subjects that only participated in Part 1 of VEG10005, who by design only received two single doses of pazopanib at study days 1 and 15, were excluded from analysis due to limited pazopanib exposure. In addition, subjects who did not have at least one on-treatment ALT measurement were excluded.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects in the eleven clinical trials who received pazopanib monotherapy for the treatment of cancer and who had at least one post-baseline ALT measurement. For the PGx analyses, inclusion was further limited to subjects with PGx consent and valid genetic data.
Exclusion criteria:
- Subjects that only participated in Part 1 of VEG10005, who by design only received two single doses of pazopanib at study days 1 and 15, were excluded from analysis due to limited pazopanib exposure. In addition, subjects who did not have at least one on-treatment ALT measurement were excluded.
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
Not applicable
Actual study completion date
2010-02-09
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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