Last updated: 02/04/2020 15:30:11

First Line and Sequential Use of Pazopanib Followed by Mammalian Target of Rapamycin (mTOR) Inhibitor Therapy among Patients with Advanced/Metastatic Renal Cell Carcinoma in a United States Community Oncology Setting

GSK study ID
200210
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: First Line and Sequential Use of Pazopanib Followed by Mammalian Target of Rapamycin (mTOR) Inhibitor Therapy among Patients with Advanced/Metastatic Renal Cell Carcinoma in a United States Community Oncology Setting
Trial description: Retrospective studies and clinical trials have investigated the sequencing of targeted therapies for the treatment of advanced renal cell carcinoma (aRCC). Specifically, the results of first-line therapy with a tyrosine-kinase inhibitor (TKI) followed by second-line therapy with different TKI and first-line TKI with a switch to a Mammalian Target of Rapamycin (mTOR) inhibitor have been evaluated. At this time, no studies have been conducted to evaluate the real-world use of pazopanib in aRCC patients treated in with first-line pazopanib then switched to an mTOR inhibitor (temsirolimus or everolimus).
The objectives of this study are to assess the patient characteristics, clinical and safety outcomes, treatment patterns, and healthcare resource use (HCRU) associated with (i) aRCC patients treated with pazopanib as first-line therapy and (ii) progressive aRCC patients first treated with pazopanib followed by treatment with an mTOR inhibitor in a community oncology setting in the United States (US). This is a descriptive study; therefore no hypotheses will be tested.
Data will be extracted from the McKesson Specialty Health/US Oncology Network database, which includes data from iKnowMed (iKM), Claims Data Warehouse (CDW), Social Security Death Index (SSDI), and medical record reviews.
This study design will be a descriptive, retrospective, and longitudinal analysis and medical records review of eligible subjects.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Time to Treatment Failure (TTTF)

Timeframe: 3 years

Progression-Free Survival (PFS)

Timeframe: 3 years

Time to Brain Metastasis (TTBM)

Timeframe: 3 years

Overall survival

Timeframe: 3 years

Adverse events (AEs)

Timeframe: 3 years

Secondary outcomes:

Health Care Resource Utilization

Timeframe: 3 years

Treatment and Utilization Patterns

Timeframe: 3 years

Interventions:
  • Drug: First-line pazopanib and second-line mTOR
  • Drug: First-line pazopanib
  • Enrollment:
    0
    Primary completion date:
    2014-17-03
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Vogelzang N, Hackshaw M, Hutson T, et al.First-line and Sequential Use of Pazopanib Followed by mTOR Inhibitor Therapy Among Patients with Advanced Renal Cell Carcinoma in a US Community Oncology Setting.Clinical Genitourinary Cancer.2015;13(3):210-217
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    July 2013 to March 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • All subjects with a diagnosis search term of ’Renal Cell Carcinoma’ in the iKM database and were diagnosed at stage III/IV or were diagnosed at early stage but developed metastatic disease
    • Subjects who received pazopanib (Cohorts I and II) as first line of therapy in the defined study period.
    • Subjects enrolled in a clinical trial.
    • Subjects diagnosed with and treated for major cancers other than RCC.

    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
    2014-17-03
    Actual study completion date
    2014-17-03

    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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