Last updated: 11/03/2018 17:44:41
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

PRINCIPAL: A Prospective Observational Study of Real World Treatment Patterns and Treatment Outcomes in Patients with Advanced or Metastatic Renal Cell Carcinoma Receiving PazopanibPRINCIPAL

GSK study ID
115232
Clinicaltrials.gov ID
NCT01649778
EudraCT ID
2011-003065-15
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: PRINCIPAL: A Prospective Observational Study of Real World Treatment Patterns and Treatment Outcomes in Patients with Advanced or Metastatic Renal Cell Carcinoma Receiving Pazopanib
Trial description: This is a global, multi-centre, long-term, prospective, observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated for the first time with pazopanib. The study is designed to enroll approximately 700-1000 patients in over the course of an enrollment period of approximately 18 months.There are no protocol–mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 30 months or until premature discontinuation (i.e., due to death, withdrawal of consent, lost to follow-up or study termination).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Evaluate Safety

Timeframe: From first treatment with pazopanib till 30 days after last dose of pazopanib treatment

Relative Dose Intensity(RDI)

Timeframe: Approximately 30 months

Evaluate the change in health-related quality of life (HRQoL)

Timeframe: Approximately 30 months from baseline

Efficacy

Timeframe: Approximately 30 months

Characterise the RCC patient population treated

Timeframe: Approximately 30 months

Secondary outcomes:

Evaluate efficacy and safety comparable to VEG105192

Timeframe: Approximately 30 months

Evaluate efficacy, safety, RDI, and HRQoL

Timeframe: Approximately 30 months

Interventions:
  • Drug: Pazopanib
    • Enrollment:
    700
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    July 2012 to June 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 99 Year
    Accepts healthy volunteers
    none
    • Patients eligible for enrolment in the study must meet all of the following criteria:
    • Age ≥ 18 years at enrollment
    • Patients meeting any of the following criteria must not be enrolled in the study:
    • Patients currently participating in any interventional clinical trials in which treatment regimen and/or monitoring is dictated by a protocol
    Inclusion and exclusion criteria
    Inclusion criteria:

      Patients eligible for enrolment in the study must meet all of the following criteria:

      • Age ≥ 18 years at enrollment
      • Documented diagnosis of advanced and/or metastatic clear cell or predominantly clear cell RCC
      • Clinical decision made to initiate treatment with pazopanib prior to enrollment in the study, but within 30 days of enrollment
      • Willing and able to provide written informed consent
    Exclusion criteria:

      Patients meeting any of the following criteria must not be enrolled in the study:

      • Patients currently participating in any interventional clinical trials in which treatment regimen and/or monitoring is dictated by a protocol
      • Previous exposure to an investigational or licensed multi-kinase inhibitor or an anti- VEGF angiogenesis inhibitor for advanced or metastatic disease
      • Life expectancy < 12 weeks

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website