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)

GSK study ID
115003
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    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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