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

Carcinoma, Renal Cell Clinical Trial

— PRINCIPAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649778
• Other study ID #: 115232
• Secondary ID: CPZP034A2401
• Status: Completed
• Start date: July 19, 2012
• Est. completion date: July 3, 2017

Study information

• Verified date: July 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: July 3, 2017
• Est. primary completion date: July 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

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.

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Berazategui	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba	Córdova
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	San Miguel de Tucuman
Argentina	Novartis Investigative Site	Santa Fe
Austria	Novartis Investigative Site	Hall in Tirol
Austria	Novartis Investigative Site	Innsbruck
Austria	Novartis Investigative Site	Leoben
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	St.Veit/Glan
Austria	Novartis Investigative Site	Voecklabruck
Austria	Novartis Investigative Site	Wien
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Arlon
Belgium	Novartis Investigative Site	Bonheiden
Belgium	Novartis Investigative Site	Bouge
Belgium	Novartis Investigative Site	Brasschaat
Belgium	Novartis Investigative Site	Edegem
Belgium	Novartis Investigative Site	Haine Saint Paul
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Oostende
Belgium	Novartis Investigative Site	Ottignies
Belgium	Novartis Investigative Site	Sint-Niklaas
Belgium	Novartis Investigative Site	Verviers
Colombia	Novartis Investigative Site	Bucaramanga
Colombia	Novartis Investigative Site	Medellin
Colombia	Novartis Investigative Site	Monteria
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Finland	Novartis Investigative Site	Helsinki
Germany	Novartis Investigative Site	Aschaffenburg	Bayern
Germany	Novartis Investigative Site	Chemnitz	Sachsen
Germany	Novartis Investigative Site	Erlangen	Bayern
Germany	Novartis Investigative Site	Frankfurt	Hessen
Germany	Novartis Investigative Site	Hof	Bayern
Germany	Novartis Investigative Site	Homburg	Saarland
Germany	Novartis Investigative Site	Kiel	Schleswig-Holstein
Germany	Novartis Investigative Site	Kirchheim	Baden-Wuerttemberg
Germany	Novartis Investigative Site	Landshut	Bayern
Germany	Novartis Investigative Site	Lehrte	Niedersachsen
Germany	Novartis Investigative Site	Magdeburg	Sachsen-Anhalt
Germany	Novartis Investigative Site	Marburg	Hessen
Germany	Novartis Investigative Site	Markkleeberg	Sachsen
Germany	Novartis Investigative Site	Muenster	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Neubrandenburg	Mecklenburg-Vorpommern
Germany	Novartis Investigative Site	Rostock	Mecklenburg-Vorpommern
Germany	Novartis Investigative Site	Velbert	Nordrhein-Westfalen
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Patra
Greece	Novartis Investigative Site	Thessaloniki
Greece	Novartis Investigative Site	Thessaloniki
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szombathely
Hungary	Novartis Investigative Site	Veszprem
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Nahariya
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Cremona	Lombardia
Italy	Novartis Investigative Site	Milano	Lombardia
Italy	Novartis Investigative Site	Modena	Emilia-Romagna
Italy	Novartis Investigative Site	Napoli	Campania
Italy	Novartis Investigative Site	Pavia	Lombardia
Italy	Novartis Investigative Site	Roma	Lazio
Italy	Novartis Investigative Site	Roma	Lazio
Italy	Novartis Investigative Site	Roma	Lazio
Lebanon	Novartis Investigative Site	Ashrafieh
Pakistan	Novartis Investigative Site	Karachi
Spain	Novartis Investigative Site	Albacete
Spain	Novartis Investigative Site	Badajoz
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Burgos
Spain	Novartis Investigative Site	Castellon
Spain	Novartis Investigative Site	Don Benito/Badajoz
Spain	Novartis Investigative Site	Guadalajara
Spain	Novartis Investigative Site	La Coruna
Spain	Novartis Investigative Site	La Laguna (Santa Cruz De Tenerife)
Spain	Novartis Investigative Site	Leon
Spain	Novartis Investigative Site	Lleida
Spain	Novartis Investigative Site	Lugo
Spain	Novartis Investigative Site	Manresa (Barcelona)
Spain	Novartis Investigative Site	Ourense
Spain	Novartis Investigative Site	Pamplona
Spain	Novartis Investigative Site	Sabadell (Barcelona)
Spain	Novartis Investigative Site	Salamanca
Spain	Novartis Investigative Site	San Sebastian
Spain	Novartis Investigative Site	Santa Cruz de Tenerife
Spain	Novartis Investigative Site	Santiago de Compostela
Spain	Novartis Investigative Site	Soria
Spain	Novartis Investigative Site	Valencia
Spain	Novartis Investigative Site	Valladolid
Spain	Novartis Investigative Site	Vigo ( Pontevedra)
Spain	Novartis Investigative Site	Zaragoza
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan Hsien
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Antalya
Turkey	Novartis Investigative Site	Antalya
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kayseri
Turkey	Novartis Investigative Site	Malatya
Turkey	Novartis Investigative Site	Samsun
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Northwood	Middlesex
United Kingdom	Novartis Investigative Site	Shrewsbury
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Bronx	New York
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Fort Worth	Texas
United States	Novartis Investigative Site	Henderson	Nevada
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Shreveport	Louisiana
United States	Novartis Investigative Site	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Colombia,  Estonia,  Finland,  Germany,  Greece,  Hungary,  Israel,  Italy,  Lebanon,  Pakistan,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	To evaluate overall survival (OS), progression-free survival (PFS) and the overall response rate (ORR) in patients treated with pazopanib	Approximately 30 months
Primary	Relative Dose Intensity(RDI)	To characterize the relative dose intensity (RDI) and its observed effect on treatment outcomes	Approximately 30 months
Primary	Characterise the RCC patient population treated	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	Approximately 30 months
Primary	Evaluate the change in health-related quality of life (HRQoL)	To evaluate the change in health-related quality of life (HRQoL) relative to baseline in patients treated with pazopanib	Approximately 30 months from baseline
Primary	Evaluate Safety	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.	From first treatment with pazopanib till 30 days after last dose of pazopanib treatment
Secondary	Evaluate efficacy and safety comparable to VEG105192	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	Approximately 30 months
Secondary	Evaluate efficacy, safety, RDI, and HRQoL	To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib	Approximately 30 months