Last updated: 11/07/2018 10:19:50

Persistence and Compliance among United States patients with advanced Renal Cell Carcinoma receiving treatment with Pazopanib

GSK study ID
116281
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: Persistence and Compliance among United States patients with advanced Renal Cell Carcinoma receiving treatment with Pazopanib
Trial description: Advances in understanding the biology and genetics associated with advanced renal cell carcinoma (aRCC) have led to novel targeted approaches for treatment including tyrosine kinase inhibitors (TKIs), mammalian target of rapamycin (mTOR) inhibitors and a monoclonal antibody. In the United States (US), pazopanib is one of the currently available, targeted, oral TKI therapies approved by the Food and Drug Administration (FDA) in 2009 for the treatment of subjects with aRCC. The current study proposes to assess treatment patterns among aRCC subjects who receive pazopanib as treatment for aRCC.
The primary objective of this study is to estimate medication persistence and compliance (adherence) among aRCC subjects receiving treatment with pazopanib. The secondary objectives are to describe demographic and clinical characteristics of aRCC subjects receiving treatment with pazopanib and to describe treatment and utilization patterns among aRCC subjects receiving treatment with pazopanib. Subjects treated with pazopanib as first or second line therapy will be included in the analyses. This is a descriptive study employing a retrospective, cohort study design.
The data sources for this study are the MarketScan Commercial Database and the MarketScan Medicare Supplemental Database. The MarketScan Commercial Database contains records of the inpatient visits, outpatient visits, and outpatient prescription-drug experience of employees and their dependents. The overall age distribution of the MarketScan Commercial population is similar to that of a nationally representative population of persons with employer-sponsored health insurance in Medical Expenditure Panel Survey (MEPS).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Medication compliance

Timeframe: October 1, 2007 to March 31, 2012

Medication persistence

Timeframe: October 1, 2007 to March 31, 2012

Secondary outcomes:

Treatment and utilization patterns

Timeframe: October 1, 2007 to March 31, 2012

Interventions:
  • Drug: Pazopanib
    • Enrollment:
    143
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Hackshaw M, Nagar S, Parks DC, Miller LA.Persistence and Compliance with Pazopanib in Patients with Advanced Renal Cell Carcinoma Within a U.S. Administrative Claims Database.J Manag Care Pharm.2014;20(6):603-10
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    October 2012 to January 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Subjects at least 18 years of age at the index date.
    • Evidence of RCC: at least 2 claims with a primary diagnosis for RCC (International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) 189.0 and/or 189.1), at least 30 days apart.
    • No evidence of additional cancers during the study period (patients whose primary cancer is not RCC).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects at least 18 years of age at the index date.
    • Evidence of RCC: at least 2 claims with a primary diagnosis for RCC (International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) 189.0 and/or 189.1), at least 30 days apart.
    • Evidence of advanced disease: at least 1 claim with a diagnosis of metastatic disease (ICD-9-CM 196.xx-199.xx). At least one primary RCC diagnosis code must appear prior to or on the same date as the claim with the metastatic diagnosis.
    • Evidence of receipt of pazopanib (any pazopanib use): at least 1 claim for pazopanib (National Drug Code (NDC) 0173-0804-09). The date of the first pharmacy claim for pazopanib during this period will be set as the “index date”.
    • Continuously enrolled in the health plan for at least 60 days prior to the index date and for at least 180 days after the index date.
    Exclusion criteria:
    • No evidence of additional cancers during the study period (patients whose primary cancer is not RCC).

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    2013-31-01

    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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