Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006444

Trial Description

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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

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Trial Acronym

PRINCIPAL

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URL of the Trial

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Brief Summary in Lay Language

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).

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Brief Summary in Scientific Language

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. Sites will
be contacted and qualified by the estimated number of advanced or metastatic RCC patients
available for enrollment annually. To the extent possible, consecutive patients meeting
inclusion/exclusion criteria will be enrolled. Sites will be required to maintain a patient
enrolment log of eligible patients at their treatment centres. This log will document how
patients came to be included or excluded from the study, in order to assess the
representativeness of the study population. The overall number of patients and sites may be
adjusted during the study to meet enrollment goals, if needed. Eligible patients will be
enrolled by medical oncologists and potentially by urologists experienced in the management
of patients with RCC, if consistent with local practice. 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). Follow-up information will be collected
approximately every 3 months (a window of ± 4 weeks around the date of the suggested data
collection will be allowed). If the patient is not seen for a regularly scheduled visit at
that time, the site may contact the patient by telephone to solicit information regarding
the events of interest and to limit loss to follow up. It is anticipated that frequency of
patient assessment and imaging will differ according to local standard practice; therefore
the quarterly data collection time points are intended to collect all assessments (with the
date of assessment) since the previous visit date.

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Organizational Data

  •   DRKS00006444
  •   2015/03/17
  •   2012/07/23
  •   no
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Secondary IDs

  •   NCT01649778  (ClinicalTrials.gov)
  •   115232  (GlaxoSmithKline)
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Health Condition or Problem studied

  •   Carcinoma, Renal Cell
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
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Interventions/Observational Groups

  •   Drug: Pazopanib
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Efficacy; time frame: Approximately 30 months; To evaluate overall survival (OS), progression-free survival (PFS) and the overall response rate (ORR) in patients treated with pazopanib
- Relative Dose Intensity(RDI); time frame: Approximately 30 months; To characterize the relative dose intensity (RDI) and its observed effect on treatment outcomes
- Characterise the RCC patient population treated; time frame: Approximately 30 months; To characterise the RCC patient population treated with pazopanib (e.g., by demographics, disease characteristics, previous RCC treatment history) in comparison to a selected clinical trial population
- Evaluate the change in health-related quality of life (HRQoL); time frame: Approximately 30 months from baseline; To evaluate the change in health-related quality of life (HRQoL) relative to baseline in patients treated with pazopanib
- Evaluate Safety; time frame: From first treatment with pazopanib till 30 days after last dose of pazopanib treatment; To evaluate the frequency of serious adverse events(SAEs) and adverse events of special interest (AESIs) in patients treated with pazopanib. Endpoint: Any adverse event that results in a pazopanib dose modification or discontinuation. Evidence of liver toxicity (e.g., increased ALT and/or AST, liver failure). New onset or worsened hypertension. Cardiac dysfunction (e.g., decreased left ventricular function, congestive heart failure). Thyroid dysfunction.

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Secondary Outcome

- Evaluate efficacy and safety comparable to VEG105192; time frame: Approximately 30 months; To evaluate clinical effectiveness, safety and RDI in those patients with comparable baseline characteristics to those included in the Phase III clinical trial [VEG105192]. Endpoints: Same as primary effectiveness, safety and RDI objectives
- Evaluate efficacy, safety, RDI, and HRQoL; time frame: Approximately 30 months; To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Austria
  •   Belgium
  •   Colombia
  •   Estonia
  •   Finland
  •   Germany
  •   Greece
  •   Israel
  •   Italy
  •   Lebanon
  •   Pakistan
  •   Spain
  •   Taiwan, Province of China
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2012/07/31
  •   700
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional 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

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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

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Addresses

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    • GlaxoSmithKline
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    • GlaxoSmithKline
    • GSK Clinical Trials 
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    • US GSK Clinical Trials Call Center 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.