Observational Study of Real World Effectiveness Data and Safety in Patients Receiving Pazopanib With Advanced or Metastatic Renal Cell Carcinoma (PRINCIPAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01649778
First received: July 23, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Carcinoma, Renal Cell
Drug: Pazopanib

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Efficacy [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluate efficacy and safety comparable to VEG105192 [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib


Biospecimen Retention:   None Retained

Not applicable. This is a Non-interventional study collecting prospective observational data.


Estimated Enrollment: 700
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pazopanib
Prospective Observational study collecting real world data on Pazopanib in patients with advanced or metastatic Renal Cell Carcinoma. Study is considered non-interventional, no drug will be provided. No study visits or procedures are mandated per protocol.
Drug: Pazopanib
Prospective Observational study collecting real world data on Pazopanib in patients with advanced or metastatic Renal Cell Carcinoma. Study is considered non-interventional, no drug will be provided. No study visits or procedures are mandated per protocol.
Other Name: Votrient

Detailed 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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This observational studies plans to recruit from cliinics that are prescribing pazopanib to patients as part local standard of practice.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649778

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 122 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01649778     History of Changes
Other Study ID Numbers: 115232
Study First Received: July 23, 2012
Last Updated: July 24, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014