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

NCT ID: NCT01649778

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 662 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-19
• Study Completion Date: 2017-07-03

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.

Conditions

Carcinoma, Renal Cell

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Pazopanib

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

Other Intervention Names

Votrient

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Phoenix, Arizona, United States

Novartis Investigative Site

Orange, California, United States

Novartis Investigative Site

Jacksonville, Florida, United States

Novartis Investigative Site

Louisville, Kentucky, United States

Novartis Investigative Site

Shreveport, Louisiana, United States

Novartis Investigative Site

Jackson, Mississippi, United States

Novartis Investigative Site

Lincoln, Nebraska, United States

Novartis Investigative Site

Henderson, Nevada, United States

Novartis Investigative Site

The Bronx, New York, United States

Novartis Investigative Site

Charleston, South Carolina, United States

Novartis Investigative Site

Sioux Falls, South Dakota, United States

Novartis Investigative Site

Austin, Texas, United States

Novartis Investigative Site

Dallas, Texas, United States

Novartis Investigative Site

Fort Worth, Texas, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

Berazategui, Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Córdoba, , Argentina

Novartis Investigative Site

San Miguel de Tucumán, , Argentina

Novartis Investigative Site

Santa Fe, , Argentina

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

Vienna, , Austria

Novartis Investigative Site

Vienna, , Austria

Novartis Investigative Site

Vöcklabruck, , Austria

Novartis Investigative Site

Antwerp, , 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

Liège, , Belgium

Novartis Investigative Site

Ostend, , Belgium

Novartis Investigative Site

Ottignies, , Belgium

Novartis Investigative Site

Sint-Niklaas, , Belgium

Novartis Investigative Site

Verviers, , Belgium

Novartis Investigative Site

Bucaramanga, , Colombia

Novartis Investigative Site

Medellín, , Colombia

Novartis Investigative Site

Montería, , Colombia

Novartis Investigative Site

Tallinn, , Estonia

Novartis Investigative Site

Tallinn, , Estonia

Novartis Investigative Site

Tartu, , Estonia

Novartis Investigative Site

Helsinki, , Finland

Novartis Investigative Site

Kirchheim, Baden-Wurttemberg, Germany

Novartis Investigative Site

Aschaffenburg, Bavaria, Germany

Novartis Investigative Site

Erlangen, Bavaria, Germany

Novartis Investigative Site

Hof, Bavaria, Germany

Novartis Investigative Site

Landshut, Bavaria, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Marburg, Hesse, Germany

Novartis Investigative Site

Lehrte, Lower Saxony, Germany

Novartis Investigative Site

Neubrandenburg, Mecklenburg-Vorpommern, Germany

Novartis Investigative Site

Rostock, Mecklenburg-Vorpommern, Germany

Novartis Investigative Site

Münster, North Rhine-Westphalia, Germany

Novartis Investigative Site

Velbert, North Rhine-Westphalia, Germany

Novartis Investigative Site

Homburg, Saarland, Germany

Novartis Investigative Site

Chemnitz, Saxony, Germany

Novartis Investigative Site

Markkleeberg, Saxony, Germany

Novartis Investigative Site

Magdeburg, Saxony-Anhalt, Germany

Novartis Investigative Site

Kiel, Schleswig-Holstein, Germany

Novartis Investigative Site

Athens, , Greece

Novartis Investigative Site

Athens, , Greece

Novartis Investigative Site

Pátrai, , Greece

Novartis Investigative Site

Thessaloniki, , Greece

Novartis Investigative Site

Thessaloniki, , Greece

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

Pécs, , Hungary

Novartis Investigative Site

Szeged, , Hungary

Novartis Investigative Site

Szombathely, , Hungary

Novartis Investigative Site

Veszprém, , Hungary

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, , Israel

Novartis Investigative Site

Napoli, Campania, Italy

Novartis Investigative Site

Modena, Emilia-Romagna, Italy

Novartis Investigative Site

Rome, Lazio, Italy

Novartis Investigative Site

Rome, Lazio, Italy

Novartis Investigative Site

Rome, Lazio, Italy

Novartis Investigative Site

Cremona, Lombardy, Italy

Novartis Investigative Site

Milan, Lombardy, Italy

Novartis Investigative Site

Pavia, Lombardy, Italy

Novartis Investigative Site

El Achrafiyé, , Lebanon

Novartis Investigative Site

Karachi, , Pakistan

Novartis Investigative Site

A Coruña, , 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

Donostia / San Sebastian, , Spain

Novartis Investigative Site

Guadalajara, , Spain

Novartis Investigative Site

La Laguna (Santa Cruz de Tenerife), , Spain

Novartis Investigative Site

León, , 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

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, , Spain

Novartis Investigative Site

Kaohsiung City, , Taiwan

Novartis Investigative Site

Kaohsiung City, , Taiwan

Novartis Investigative Site

Taichung, , Taiwan

Novartis Investigative Site

Taipei, , Taiwan

Novartis Investigative Site

Taipei, , Taiwan

Novartis Investigative Site

Taoyuan Hsien, , Taiwan

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Novartis Investigative Site

Antalya, , Turkey (Türkiye)

Novartis Investigative Site

Antalya, , Turkey (Türkiye)

Novartis Investigative Site

Istanbul, , Turkey (Türkiye)

Novartis Investigative Site

Istanbul, , Turkey (Türkiye)

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Novartis Investigative Site

Kayseri, , Turkey (Türkiye)

Novartis Investigative Site

Malatya, , Turkey (Türkiye)

Novartis Investigative Site

Samsun, , Turkey (Türkiye)

Novartis Investigative Site

Northwood, Middlesex, United Kingdom

Novartis Investigative Site

Birmingham, , United Kingdom

Novartis Investigative Site

Leicester, , United Kingdom

Novartis Investigative Site

Manchester, , United Kingdom

Novartis Investigative Site

Shrewsbury, , United Kingdom

Countries

United States; Argentina; Austria; Belgium; Colombia; Estonia; Finland; Germany; Greece; Hungary; Israel; Italy; Lebanon; Pakistan; Spain; Taiwan; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31196680 (View on PubMed)

Other Identifiers

CPZP034A2401

Identifier Type: OTHER

Identifier Source: secondary_id

115232

Identifier Type: -

Identifier Source: org_study_id