Clinical trial NCT01649778: Observational Study of Real World Effectiveness Data and Safety in Patients Receiving Pazopanib With Advanced or Metastatic Renal Cell Carcinoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-07-25
Enrollment: 662
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

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 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

Primary outcomes:
measure: Efficacy
timeFrame: Approximately 30 months
measure: Relative Dose Intensity(RDI)
timeFrame: Approximately 30 months
measure: Characterise the RCC patient population treated
timeFrame: Approximately 30 months
measure: Evaluate the change in health-related quality of life (HRQoL)
timeFrame: Approximately 30 months from baseline
measure: Evaluate Safety
timeFrame: From first treatment with pazopanib till 30 days after last dose of pazopanib treatment
Secondary outcomes:
measure: Evaluate efficacy and safety comparable to VEG105192
timeFrame: Approximately 30 months
measure: Evaluate efficacy, safety, RDI, and HRQoL
timeFrame: Approximately 30 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Orange
country: United States
facility: Novartis Investigative Site
state: California
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Shreveport
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Henderson
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Bronx
country: United States
facility: Novartis Investigative Site
state: New York
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Novartis Investigative Site
state: South Dakota
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Berazategui
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
state: Córdova
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
city: Hall in Tirol
country: Austria
facility: Novartis Investigative Site
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Leoben
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: St.Veit/Glan
country: Austria
facility: Novartis Investigative Site
city: Voecklabruck
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Arlon
country: Belgium
facility: Novartis Investigative Site
city: Bonheiden
country: Belgium
facility: Novartis Investigative Site
city: Bouge
country: Belgium
facility: Novartis Investigative Site
city: Brasschaat
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Haine Saint Paul
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Oostende
country: Belgium
facility: Novartis Investigative Site
city: Ottignies
country: Belgium
facility: Novartis Investigative Site
city: Sint-Niklaas
country: Belgium
facility: Novartis Investigative Site
city: Verviers
country: Belgium
facility: Novartis Investigative Site
city: Bucaramanga
country: Colombia
facility: Novartis Investigative Site
city: Medellin
country: Colombia
facility: Novartis Investigative Site
city: Monteria
country: Colombia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Kirchheim
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Erlangen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Hof
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Landshut
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Marburg
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Neubrandenburg
country: Germany
facility: Novartis Investigative Site
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: Novartis Investigative Site
state: Mecklenburg-Vorpommern
city: Lehrte
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Muenster
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Novartis Investigative Site
state: Saarland
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Markkleeberg
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Kiel
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Patra
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Szombathely
country: Hungary
facility: Novartis Investigative Site
city: Veszprem
country: Hungary
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Nahariya
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
state: Campania
city: Modena
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Cremona
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Milano
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Ashrafieh
country: Lebanon
facility: Novartis Investigative Site
city: Karachi
country: Pakistan
facility: Novartis Investigative Site
city: Albacete
country: Spain
facility: Novartis Investigative Site
city: Badajoz
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Burgos
country: Spain
facility: Novartis Investigative Site
city: Castellon
country: Spain
facility: Novartis Investigative Site
city: Don Benito/Badajoz
country: Spain
facility: Novartis Investigative Site
city: Guadalajara
country: Spain
facility: Novartis Investigative Site
city: La Coruna
country: Spain
facility: Novartis Investigative Site
city: La Laguna (Santa Cruz De Tenerife)
country: Spain
facility: Novartis Investigative Site
city: Leon
country: Spain
facility: Novartis Investigative Site
city: Lleida
country: Spain
facility: Novartis Investigative Site
city: Lugo
country: Spain
facility: Novartis Investigative Site
city: Manresa (Barcelona)
country: Spain
facility: Novartis Investigative Site
city: Ourense
country: Spain
facility: Novartis Investigative Site
city: Pamplona
country: Spain
facility: Novartis Investigative Site
city: Sabadell (Barcelona)
country: Spain
facility: Novartis Investigative Site
city: Salamanca
country: Spain
facility: Novartis Investigative Site
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novartis Investigative Site
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
city: Soria
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Valladolid
country: Spain
facility: Novartis Investigative Site
city: Vigo ( Pontevedra)
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan Hsien
country: Taiwan
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kayseri
country: Turkey
facility: Novartis Investigative Site
city: Malatya
country: Turkey
facility: Novartis Investigative Site
city: Samsun
country: Turkey
facility: Novartis Investigative Site
city: Northwood
country: United Kingdom
facility: Novartis Investigative Site
state: Middlesex
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Shrewsbury
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Procopio G, Bamias A, Schmidinger M, Hawkins R, Sanchez AR, Estevez SV, Srihari N, Kalofonos H, Bono P, Pisal CB, Hirschberg Y, Dezzani L, Ahmad Q, Rodriguez CS, Jonasch E. Real-world Effectiveness and Safety of Pazopanib in Patients With Intermediate Prognostic Risk Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2019 Jun;17(3):e526-e533. doi: 10.1016/j.clgc.2019.01.018.