Last updated: 02/04/2020 15:30:06

Persistence and Compliance among United States Patients Receiving Pazopanib or Sunitinib as First-Line Therapy for Advanced Renal Cell Carcinoma

GSK study ID
200211
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: Persistence and Compliance among United States Patients Receiving Pazopanib or Sunitinib as First‐Line Therapy for Advanced Renal Cell Carcinoma
Trial description: Randomized controlled clinical trials have demonstrated that pazopanib and sunitinib are safe and effective treatments when used as first‐line therapy for advanced renal cell carcinoma (RCC). An understanding of the treatment and utilization patterns associated with these drugs outside of a controlled setting will be useful to decision makers. The study will assess and compare persistence and compliance among patients who receive pazopanib versus sunitinib as first‐line therapy for advanced RCC. Persistence with treatment is defined as the duration of time from therapy initiation to discontinuation. Compliance refers to the consistency and accuracy of the prescribed drug treatment regimen.
The primary objectives of this study are to estimate and compare medication persistence and compliance among matched subjects who initiate first‐line therapy with pazopanib or sunitinib for the management of advanced RCC. The null hypotheses are that persistence with first‐line pazopanib will not differ from first-line sunitinib, and that compliance with first-line pazopanib will not differ from first-line sunitinib. The test hypotheses are that persistence with first‐line pazopanib will be greater than with first-line sunitinib and that compliance with first-line pazopanib will be greater than with first-line sunitinib.
The secondary objectives are to describe and compare clinical outcomes, such as adverse events and mortality, and treatment patterns among advanced RCC patients who receive pazopanib versus sunitinib as first‐line therapy. The study is a comparative study employing a retrospective, cohort design.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Compliance - Medication Possession Ratio (MPR)

Timeframe: 6 months

Persistance

Timeframe: 6 months

Secondary outcomes:

Adverse Events

Timeframe: 6 months

Survival

Timeframe: 6 months

Initiation of a new drug

Timeframe: 6 months

Dosing

Timeframe: 6 months

Interventions:
  • Drug: Sunitinib
  • Drug: Pazopanib
  • Enrollment:
    0
    Primary completion date:
    2014-21-02
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    DaCosta Byfield S, McPheeters J, Burton T, Nagar S, Hackshaw M.Persistence and Compliance among US Patients Receiving Pazopanib or Sunitinib as First-Line Therapy for Advanced Renal Cell Carcinoma: A Retrospective Claims Analysis.J Manag Care Spec Pharm.2015;21(6):515-22
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib, sunitinib
    Collaborators
    Not applicable
    Study date(s)
    June 2013 to February 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Evidence of RCC: At least 2 diagnosis claims with a primary diagnosis code for RCC at least 30 days apart, between 01 April 2009 and 30 June 2012 identified by International Classification of Disease, Ninth Revision, Clinical Modification (ICD‐9‐CM) code 189.0 and/or 189.1
    • Evidence of Advanced RCC: At least 2 claims with a diagnosis of advanced or metastatic disease (ICD‐9‐CM 196.xx‐199.xx), at least 30 days apart, in any position on the claim between 01 October 2009 and 30 June 2012
    • Multiple tumors: Subjects with medical claims for another primary cancer that is not associated with common RCC metastatic sites (i.e. lung ICD‐9‐CM 162.xx, bone 170.xx, brain 191.xx, liver 155,xx) during the study period
    • Dual therapy: Subjects with claims for both pazopanib and sunitinib on the index date will be excluded from the study sample.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    Actual primary completion date
    2014-21-02
    Actual study completion date
    2014-21-02

    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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