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

NCT01649778 | Completed

• 2 other identifiers: 115232CPZP034A2401
• Study Type: observational
• Target: 662
• Locations: 17 countries
• Sites: 141

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).

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (5)

• Efficacy

  To evaluate overall survival (OS), progression-free survival (PFS) and the overall response rate (ORR) in patients treated with pazopanib

  Approximately 30 months

• Relative Dose Intensity(RDI)

  To characterize the relative dose intensity (RDI) and its observed effect on treatment outcomes

  Approximately 30 months

• 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

• 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

• 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 Outcomes (2)

• Evaluate efficacy and safety comparable to VEG105192

  Approximately 30 months

• Evaluate efficacy, safety, RDI, and HRQoL

  Approximately 30 months

Study Arms (1)

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

Interventions

Pazopanib 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.

Also known as: Votrient

Pazopanib

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (144)

Novartis Investigative Site

Phoenix, Arizona, 85016, United States

Location

Novartis Investigative Site

Orange, California, 92868, United States

Location

Novartis Investigative Site

Jacksonville, Florida, 32256, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40207, United States

Location

Novartis Investigative Site

Shreveport, Louisiana, 71101, United States

Location

Novartis Investigative Site

Jackson, Mississippi, 39202, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68510, United States

Location

Novartis Investigative Site

Henderson, Nevada, 89052, United States

Location

Novartis Investigative Site

The Bronx, New York, 10467, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29414, United States

Location

Novartis Investigative Site

Sioux Falls, South Dakota, 57105, United States

Location

Novartis Investigative Site

Austin, Texas, 78705, United States

Location

Novartis Investigative Site

Dallas, Texas, 75246, United States

Location

Novartis Investigative Site

Fort Worth, Texas, 76104, United States

Location

Novartis Investigative Site

Houston, Texas, 77024, United States

Location

Novartis Investigative Site

Berazategui, Buenos Aires, B1880BBF, Argentina

Location

Novartis Investigative Site

Córdoba, Córdoba Province, X5006HBF, Argentina

Location

Novartis Investigative Site

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

Novartis Investigative Site

Córdoba, X5004FHP, Argentina

Location

Novartis Investigative Site

San Miguel de Tucumán, T4000IAK, Argentina

Location

Novartis Investigative Site

Santa Fe, 3000, Argentina

Location

Novartis Investigative Site

Hall in Tirol, 6060, Austria

Location

Novartis Investigative Site

Innsbruck, 6020, Austria

Location

Novartis Investigative Site

Leoben, 8700, Austria

Location

Novartis Investigative Site

Linz, 4021, Austria

Location

Novartis Investigative Site

Salzburg, 5020, Austria

Location

Novartis Investigative Site

St.Veit/Glan, 9300, Austria

Location

Novartis Investigative Site

Vienna, 1090, Austria

Location

Novartis Investigative Site

Vienna, 1220, Austria

Location

Novartis Investigative Site

Vöcklabruck, 4840, Austria

Location

Novartis Investigative Site

Antwerp, 2020, Belgium

Location

Novartis Investigative Site

Arlon, 6700, Belgium

Location

Novartis Investigative Site

Bonheiden, 2820, Belgium

Location

Novartis Investigative Site

Bouge, 5004, Belgium

Location

Novartis Investigative Site

Brasschaat, 2930, Belgium

Location

Novartis Investigative Site

Edegem, 2650, Belgium

Location

Novartis Investigative Site

Haine-Saint-Paul, 7100, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Ostend, 8400, Belgium

Location

Novartis Investigative Site

Ottignies, 1340, Belgium

Location

Novartis Investigative Site

Sint-Niklaas, 9100, Belgium

Location

Novartis Investigative Site

Verviers, 4800, Belgium

Location

Novartis Investigative Site

Bucaramanga, Colombia

Location

Novartis Investigative Site

Medellín, Colombia

Location

Novartis Investigative Site

Montería, Colombia

Location

Novartis Investigative Site

Tallinn, 10138, Estonia

Location

Novartis Investigative Site

Tallinn, 13419, Estonia

Location

Novartis Investigative Site

Tartu, 51014, Estonia

Location

Novartis Investigative Site

Helsinki, 00029, Finland

Location

Novartis Investigative Site

Kirchheim, Baden-Wurttemberg, 73230, Germany

Location

Novartis Investigative Site

Aschaffenburg, Bavaria, 63739, Germany

Location

Novartis Investigative Site

Erlangen, Bavaria, 91054, Germany

Location

Novartis Investigative Site

Hof, Bavaria, 95028, Germany

Location

Novartis Investigative Site

Landshut, Bavaria, 84028, Germany

Location

Novartis Investigative Site

Frankfurt am Main, Hesse, 60431, Germany

Location

Novartis Investigative Site

Marburg, Hesse, 35043, Germany

Location

Novartis Investigative Site

Lehrte, Lower Saxony, 31275, Germany

Location

Novartis Investigative Site

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

Location

Novartis Investigative Site

Rostock, Mecklenburg-Vorpommern, 18107, Germany

Location

Novartis Investigative Site

Münster, North Rhine-Westphalia, 48149, Germany

Location

Novartis Investigative Site

Velbert, North Rhine-Westphalia, 42551, Germany

Location

Novartis Investigative Site

Homburg, Saarland, 66421, Germany

Location

Novartis Investigative Site

Chemnitz, Saxony, 09130, Germany

Location

Novartis Investigative Site

Markkleeberg, Saxony, 04416, Germany

Location

Novartis Investigative Site

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Novartis Investigative Site

Kiel, Schleswig-Holstein, 24105, Germany

Location

Novartis Investigative Site

Athens, 115 28, Greece

Location

Novartis Investigative Site

Athens, 11522, Greece

Location

Novartis Investigative Site

Pátrai, 26504, Greece

Location

Novartis Investigative Site

Thessaloniki, 564 29, Greece

Location

Novartis Investigative Site

Thessaloniki, Greece

Location

Novartis Investigative Site

Budapest, 1082, Hungary

Location

Novartis Investigative Site

Budapest, 1097, Hungary

Location

Novartis Investigative Site

Budapest, 1122, Hungary

Location

Novartis Investigative Site

Budapest, 1145, Hungary

Location

Novartis Investigative Site

Debrecen, H-4032, Hungary

Location

Novartis Investigative Site

Pécs, 7624, Hungary

Location

Novartis Investigative Site

Szeged, 6720, Hungary

Location

Novartis Investigative Site

Szombathely, 9700, Hungary

Location

Novartis Investigative Site

Veszprém, 8200, Hungary

Location

Novartis Investigative Site

Haifa, 31048, Israel

Location

Novartis Investigative Site

Haifa, 31096, Israel

Location

Novartis Investigative Site

Jerusalem, 91120, Israel

Location

Novartis Investigative Site

Nahariya, 22100, Israel

Location

Novartis Investigative Site

Tel Aviv, 64239, Israel

Location

Novartis Investigative Site

Napoli, Campania, 80131, Italy

Location

Novartis Investigative Site

Modena, Emilia-Romagna, 41100, Italy

Location

Novartis Investigative Site

Rome, Lazio, 00144, Italy

Location

Novartis Investigative Site

Rome, Lazio, 00152, Italy

Location

Novartis Investigative Site

Rome, Lazio, 00168, Italy

Location

Novartis Investigative Site

Cremona, Lombardy, 26100, Italy

Location

Novartis Investigative Site

Milan, Lombardy, 20133, Italy

Location

Novartis Investigative Site

Pavia, Lombardy, 27100, Italy

Location

Novartis Investigative Site

El Achrafiyé, 166484, Lebanon

Location

Novartis Investigative Site

Karachi, 74800, Pakistan

Location

Novartis Investigative Site

A Coruña, 15006, Spain

Location

Novartis Investigative Site

Albacete, 02006, Spain

Location

Novartis Investigative Site

Badajoz, 06080, Spain

Location

Novartis Investigative Site

Barcelona, 08003, Spain

Location

Novartis Investigative Site

Barcelona, 08035, Spain

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Burgos, 09006, Spain

Location

Novartis Investigative Site

Castellon, 12002, Spain

Location

Novartis Investigative Site

Don Benito/Badajoz, 06400, Spain

Location

Novartis Investigative Site

Donostia / San Sebastian, 20014, Spain

Location

Novartis Investigative Site

Guadalajara, 19002, Spain

Location

Novartis Investigative Site

La Laguna (Santa Cruz de Tenerife), 38320, Spain

Location

Novartis Investigative Site

León, 24071, Spain

Location

Novartis Investigative Site

Lleida, 25198, Spain

Location

Novartis Investigative Site

Lugo, 27003, Spain

Location

Novartis Investigative Site

Manresa (Barcelona), 08243, Spain

Location

Novartis Investigative Site

Ourense, 32005, Spain

Location

Novartis Investigative Site

Pamplona, 31008, Spain

Location

Novartis Investigative Site

Sabadell (Barcelona), 08208, Spain

Location

Novartis Investigative Site

Salamanca, 37007, Spain

Location

Novartis Investigative Site

Santa Cruz de Tenerife, 38010, Spain

Location

Novartis Investigative Site

Santiago de Compostela, 15706, Spain

Location

Novartis Investigative Site

Soria, 42002, Spain

Location

Novartis Investigative Site

Valencia, 46009, Spain

Location

Novartis Investigative Site

Valladolid, 47005, Spain

Location

Novartis Investigative Site

Vigo ( Pontevedra), 36204, Spain

Location

Novartis Investigative Site

Zaragoza, 50009, Spain

Location

Novartis Investigative Site

Kaohsiung City, 807, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 813, Taiwan

Location

Novartis Investigative Site

Taichung, 40402, Taiwan

Location

Novartis Investigative Site

Taipei, 104, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan

Location

Novartis Investigative Site

Taoyuan Hsien, ROC, Taiwan

Location

Novartis Investigative Site

Ankara, 06500, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Turkey (Türkiye)

Location

Novartis Investigative Site

Antalya, 07059, Turkey (Türkiye)

Location

Novartis Investigative Site

Antalya, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34365, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34390, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, Turkey (Türkiye)

Location

Novartis Investigative Site

Kayseri, 38039, Turkey (Türkiye)

Location

Novartis Investigative Site

Malatya, Turkey (Türkiye)

Location

Novartis Investigative Site

Samsun, 55139, Turkey (Türkiye)

Location

Novartis Investigative Site

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Novartis Investigative Site

Birmingham, B9 5SS, United Kingdom

Location

Novartis Investigative Site

Leicester, LE1 5WW, United Kingdom

Location

Novartis Investigative Site

Manchester, M20 4BX, United Kingdom

Location

Novartis Investigative Site

Shrewsbury, SY3 8XQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31196680 DERIVED

Biospecimen

Retention: NONE RETAINED

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: July 19, 2012
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

ES (28); DE (17); AU (9); TW (6); FI (1); GB (5); CO (3); HU (9); US (15); IT (8); PA (1); IL (5); TU (10); LE (1); AR (6); BE (12); GR (5)