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| ID | Type | Description | Link |
|---|---|---|---|
| CPZP034A2401 | Other Identifier | Novartis |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patients eligible for enrolment in the study must meet all of the following criteria:
Exclusion Criteria:
Patients meeting any of the following criteria must not be enrolled in the study:
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This observational studies plans to recruit from cliinics that are prescribing pazopanib to patients as part local standard of practice.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85016 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31196680 | Derived | 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. |
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Not applicable. This is a Non-interventional study collecting prospective observational data.
|
| Evaluate efficacy, safety, RDI, and HRQoL |
To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib |
| Approximately 30 months |
| Orange |
| California |
| 92868 |
| United States |
| Novartis Investigative Site | Jacksonville | Florida | 32256 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40207 | United States |
| Novartis Investigative Site | Shreveport | Louisiana | 71101 | United States |
| Novartis Investigative Site | Jackson | Mississippi | 39202 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68510 | United States |
| Novartis Investigative Site | Henderson | Nevada | 89052 | United States |
| Novartis Investigative Site | The Bronx | New York | 10467 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29414 | United States |
| Novartis Investigative Site | Sioux Falls | South Dakota | 57105 | United States |
| Novartis Investigative Site | Austin | Texas | 78705 | United States |
| Novartis Investigative Site | Dallas | Texas | 75246 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76104 | United States |
| Novartis Investigative Site | Houston | Texas | 77024 | United States |
| Novartis Investigative Site | Berazategui | Buenos Aires | B1880BBF | Argentina |
| Novartis Investigative Site | Córdoba | Córdoba Province | X5006HBF | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Novartis Investigative Site | Córdoba | X5004FHP | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | T4000IAK | Argentina |
| Novartis Investigative Site | Santa Fe | 3000 | Argentina |
| Novartis Investigative Site | Hall in Tirol | 6060 | Austria |
| Novartis Investigative Site | Innsbruck | 6020 | Austria |
| Novartis Investigative Site | Leoben | 8700 | Austria |
| Novartis Investigative Site | Linz | 4021 | Austria |
| Novartis Investigative Site | Salzburg | 5020 | Austria |
| Novartis Investigative Site | St.Veit/Glan | 9300 | Austria |
| Novartis Investigative Site | Vienna | 1090 | Austria |
| Novartis Investigative Site | Vienna | 1220 | Austria |
| Novartis Investigative Site | Vöcklabruck | 4840 | Austria |
| Novartis Investigative Site | Antwerp | 2020 | Belgium |
| Novartis Investigative Site | Arlon | 6700 | Belgium |
| Novartis Investigative Site | Bonheiden | 2820 | Belgium |
| Novartis Investigative Site | Bouge | 5004 | Belgium |
| Novartis Investigative Site | Brasschaat | 2930 | Belgium |
| Novartis Investigative Site | Edegem | 2650 | Belgium |
| Novartis Investigative Site | Haine-Saint-Paul | 7100 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Ostend | 8400 | Belgium |
| Novartis Investigative Site | Ottignies | 1340 | Belgium |
| Novartis Investigative Site | Sint-Niklaas | 9100 | Belgium |
| Novartis Investigative Site | Verviers | 4800 | Belgium |
| Novartis Investigative Site | Bucaramanga | Colombia |
| Novartis Investigative Site | Medellín | Colombia |
| Novartis Investigative Site | Montería | Colombia |
| Novartis Investigative Site | Tallinn | 10138 | Estonia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tartu | 51014 | Estonia |
| Novartis Investigative Site | Helsinki | 00029 | Finland |
| Novartis Investigative Site | Kirchheim | Baden-Wurttemberg | 73230 | Germany |
| Novartis Investigative Site | Aschaffenburg | Bavaria | 63739 | Germany |
| Novartis Investigative Site | Erlangen | Bavaria | 91054 | Germany |
| Novartis Investigative Site | Hof | Bavaria | 95028 | Germany |
| Novartis Investigative Site | Landshut | Bavaria | 84028 | Germany |
| Novartis Investigative Site | Frankfurt am Main | Hesse | 60431 | Germany |
| Novartis Investigative Site | Marburg | Hesse | 35043 | Germany |
| Novartis Investigative Site | Lehrte | Lower Saxony | 31275 | Germany |
| Novartis Investigative Site | Neubrandenburg | Mecklenburg-Vorpommern | 17036 | Germany |
| Novartis Investigative Site | Rostock | Mecklenburg-Vorpommern | 18107 | Germany |
| Novartis Investigative Site | Münster | North Rhine-Westphalia | 48149 | Germany |
| Novartis Investigative Site | Velbert | North Rhine-Westphalia | 42551 | Germany |
| Novartis Investigative Site | Homburg | Saarland | 66421 | Germany |
| Novartis Investigative Site | Chemnitz | Saxony | 09130 | Germany |
| Novartis Investigative Site | Markkleeberg | Saxony | 04416 | Germany |
| Novartis Investigative Site | Magdeburg | Saxony-Anhalt | 39104 | Germany |
| Novartis Investigative Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| Novartis Investigative Site | Athens | 115 28 | Greece |
| Novartis Investigative Site | Athens | 11522 | Greece |
| Novartis Investigative Site | Pátrai | 26504 | Greece |
| Novartis Investigative Site | Thessaloniki | 564 29 | Greece |
| Novartis Investigative Site | Thessaloniki | Greece |
| Novartis Investigative Site | Budapest | 1082 | Hungary |
| Novartis Investigative Site | Budapest | 1097 | Hungary |
| Novartis Investigative Site | Budapest | 1122 | Hungary |
| Novartis Investigative Site | Budapest | 1145 | Hungary |
| Novartis Investigative Site | Debrecen | H-4032 | Hungary |
| Novartis Investigative Site | Pécs | 7624 | Hungary |
| Novartis Investigative Site | Szeged | 6720 | Hungary |
| Novartis Investigative Site | Szombathely | 9700 | Hungary |
| Novartis Investigative Site | Veszprém | 8200 | Hungary |
| Novartis Investigative Site | Haifa | 31048 | Israel |
| Novartis Investigative Site | Haifa | 31096 | Israel |
| Novartis Investigative Site | Jerusalem | 91120 | Israel |
| Novartis Investigative Site | Nahariya | 22100 | Israel |
| Novartis Investigative Site | Tel Aviv | 64239 | Israel |
| Novartis Investigative Site | Naples | Campania | 80131 | Italy |
| Novartis Investigative Site | Modena | Emilia-Romagna | 41100 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00144 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00152 | Italy |
| Novartis Investigative Site | Rome | Lazio | 00168 | Italy |
| Novartis Investigative Site | Cremona | Lombardy | 26100 | Italy |
| Novartis Investigative Site | Milan | Lombardy | 20133 | Italy |
| Novartis Investigative Site | Pavia | Lombardy | 27100 | Italy |
| Novartis Investigative Site | El Achrafiyé | 166484 | Lebanon |
| Novartis Investigative Site | Karachi | 74800 | Pakistan |
| Novartis Investigative Site | A Coruña | 15006 | Spain |
| Novartis Investigative Site | Albacete | 02006 | Spain |
| Novartis Investigative Site | Badajoz | 06080 | Spain |
| Novartis Investigative Site | Barcelona | 08003 | Spain |
| Novartis Investigative Site | Barcelona | 08035 | Spain |
| Novartis Investigative Site | Barcelona | 08036 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Burgos | 09006 | Spain |
| Novartis Investigative Site | Castellon | 12002 | Spain |
| Novartis Investigative Site | Don Benito/Badajoz | 06400 | Spain |
| Novartis Investigative Site | Donostia / San Sebastian | 20014 | Spain |
| Novartis Investigative Site | Guadalajara | 19002 | Spain |
| Novartis Investigative Site | La Laguna (Santa Cruz de Tenerife) | 38320 | Spain |
| Novartis Investigative Site | León | 24071 | Spain |
| Novartis Investigative Site | Lleida | 25198 | Spain |
| Novartis Investigative Site | Lugo | 27003 | Spain |
| Novartis Investigative Site | Manresa (Barcelona) | 08243 | Spain |
| Novartis Investigative Site | Ourense | 32005 | Spain |
| Novartis Investigative Site | Pamplona | 31008 | Spain |
| Novartis Investigative Site | Sabadell (Barcelona) | 08208 | Spain |
| Novartis Investigative Site | Salamanca | 37007 | Spain |
| Novartis Investigative Site | Santa Cruz de Tenerife | 38010 | Spain |
| Novartis Investigative Site | Santiago de Compostela | 15706 | Spain |
| Novartis Investigative Site | Soria | 42002 | Spain |
| Novartis Investigative Site | Valencia | 46009 | Spain |
| Novartis Investigative Site | Valladolid | 47005 | Spain |
| Novartis Investigative Site | Vigo ( Pontevedra) | 36204 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Kaohsiung City | 807 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 813 | Taiwan |
| Novartis Investigative Site | Taichung | 40402 | Taiwan |
| Novartis Investigative Site | Taipei | 104 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan |
| Novartis Investigative Site | Taoyuan Hsien | ROC | Taiwan |
| Novartis Investigative Site | Ankara | 06500 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | Turkey (Türkiye) |
| Novartis Investigative Site | Antalya | 07059 | Turkey (Türkiye) |
| Novartis Investigative Site | Antalya | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34365 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34390 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | Turkey (Türkiye) |
| Novartis Investigative Site | Kayseri | 38039 | Turkey (Türkiye) |
| Novartis Investigative Site | Malatya | Turkey (Türkiye) |
| Novartis Investigative Site | Samsun | 55139 | Turkey (Türkiye) |
| Novartis Investigative Site | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Novartis Investigative Site | Birmingham | B9 5SS | United Kingdom |
| Novartis Investigative Site | Leicester | LE1 5WW | United Kingdom |
| Novartis Investigative Site | Manchester | M20 4BX | United Kingdom |
| Novartis Investigative Site | Shrewsbury | SY3 8XQ | United Kingdom |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C516667 | pazopanib |
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