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

PRINCIPAL: A Prospective Observational Study of Real World Treatment Patterns and Treatment Outcomes in Patients With Advanced or Metastatic Renal Cell Carcinoma Receiving Pazopanib

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).

Study Overview

• Status: Completed
• Conditions: Carcinoma, Renal Cell
• Intervention / Treatment: Drug: Pazopanib

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.

• Study Type: Observational
• Enrollment (Actual): 662

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5004FHP
    • Novartis Investigative Site
  • San Miguel de Tucuman, Argentina, T4000IAK
    • Novartis Investigative Site
  • Santa Fe, Argentina, 3000
    • Novartis Investigative Site
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, B1880BBF
      • Novartis Investigative Site
  • Córdova
    • Cordoba, Córdova, Argentina, X5006HBF
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000KZE
      • Novartis Investigative Site
• Austria
  • Hall in Tirol, Austria, 6060
    • Novartis Investigative Site
  • Innsbruck, Austria, 6020
    • Novartis Investigative Site
  • Leoben, Austria, 8700
    • Novartis Investigative Site
  • Linz, Austria, 4021
    • Novartis Investigative Site
  • Salzburg, Austria, 5020
    • Novartis Investigative Site
  • St.Veit/Glan, Austria, 9300
    • Novartis Investigative Site
  • Voecklabruck, Austria, 4840
    • Novartis Investigative Site
  • Wien, Austria, 1090
    • Novartis Investigative Site
  • Wien, Austria, 1220
    • Novartis Investigative Site
• Belgium
  • Antwerpen, Belgium, 2020
    • Novartis Investigative Site
  • Arlon, Belgium, 6700
    • Novartis Investigative Site
  • Bonheiden, Belgium, 2820
    • Novartis Investigative Site
  • Bouge, Belgium, 5004
    • Novartis Investigative Site
  • Brasschaat, Belgium, 2930
    • Novartis Investigative Site
  • Edegem, Belgium, 2650
    • Novartis Investigative Site
  • Haine Saint Paul, Belgium, 7100
    • Novartis Investigative Site
  • Liege, Belgium, 4000
    • Novartis Investigative Site
  • Oostende, Belgium, 8400
    • Novartis Investigative Site
  • Ottignies, Belgium, 1340
    • Novartis Investigative Site
  • Sint-Niklaas, Belgium, 9100
    • Novartis Investigative Site
  • Verviers, Belgium, 4800
    • Novartis Investigative Site
• Colombia
  • Bucaramanga, Colombia
    • Novartis Investigative Site
  • Medellin, Colombia
    • Novartis Investigative Site
  • Monteria, Colombia
    • Novartis Investigative Site
• Estonia
  • Tallinn, Estonia, 13419
    • Novartis Investigative Site
  • Tallinn, Estonia, 10138
    • Novartis Investigative Site
  • Tartu, Estonia, 51014
    • Novartis Investigative Site
• Finland
  • Helsinki, Finland, 00029
    • Novartis Investigative Site
• Germany
  • Baden-Wuerttemberg
    • Kirchheim, Baden-Wuerttemberg, Germany, 73230
      • Novartis Investigative Site
  • Bayern
    • Aschaffenburg, Bayern, Germany, 63739
      • Novartis Investigative Site
    • Erlangen, Bayern, Germany, 91054
      • Novartis Investigative Site
    • Hof, Bayern, Germany, 95028
      • Novartis Investigative Site
    • Landshut, Bayern, Germany, 84028
      • Novartis Investigative Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60431
      • Novartis Investigative Site
    • Marburg, Hessen, Germany, 35043
      • Novartis Investigative Site
  • Mecklenburg-Vorpommern
    • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
      • Novartis Investigative Site
    • Rostock, Mecklenburg-Vorpommern, Germany, 18107
      • Novartis Investigative Site
  • Niedersachsen
    • Lehrte, Niedersachsen, Germany, 31275
      • Novartis Investigative Site
  • Nordrhein-Westfalen
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • Novartis Investigative Site
    • Velbert, Nordrhein-Westfalen, Germany, 42551
      • Novartis Investigative Site
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Novartis Investigative Site
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09130
      • Novartis Investigative Site
    • Markkleeberg, Sachsen, Germany, 04416
      • Novartis Investigative Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39104
      • Novartis Investigative Site
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Novartis Investigative Site
• Greece
  • Athens, Greece, 115 28
    • Novartis Investigative Site
  • Athens, Greece, 11522
    • Novartis Investigative Site
  • Patra, Greece, 26504
    • Novartis Investigative Site
  • Thessaloniki, Greece, 564 29
    • Novartis Investigative Site
  • Thessaloniki, Greece
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, 1082
    • Novartis Investigative Site
  • Budapest, Hungary, 1145
    • Novartis Investigative Site
  • Budapest, Hungary, 1097
    • Novartis Investigative Site
  • Budapest, Hungary, 1122
    • Novartis Investigative Site
  • Debrecen, Hungary, H-4032
    • Novartis Investigative Site
  • Pecs, Hungary, 7624
    • Novartis Investigative Site
  • Szeged, Hungary, 6720
    • Novartis Investigative Site
  • Szombathely, Hungary, 9700
    • Novartis Investigative Site
  • Veszprem, Hungary, 8200
    • Novartis Investigative Site
• Israel
  • Haifa, Israel, 31096
    • Novartis Investigative Site
  • Haifa, Israel, 31048
    • Novartis Investigative Site
  • Jerusalem, Israel, 91120
    • Novartis Investigative Site
  • Nahariya, Israel, 22100
    • Novartis Investigative Site
  • Tel Aviv, Israel, 64239
    • Novartis Investigative Site
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Novartis Investigative Site
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41100
      • Novartis Investigative Site
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Novartis Investigative Site
    • Roma, Lazio, Italy, 00144
      • Novartis Investigative Site
    • Roma, Lazio, Italy, 00152
      • Novartis Investigative Site
  • Lombardia
    • Cremona, Lombardia, Italy, 26100
      • Novartis Investigative Site
    • Milano, Lombardia, Italy, 20133
      • Novartis Investigative Site
    • Pavia, Lombardia, Italy, 27100
      • Novartis Investigative Site
• Lebanon
  • Ashrafieh, Lebanon, 166484
    • Novartis Investigative Site
• Pakistan
  • Karachi, Pakistan, 74800
    • Novartis Investigative Site
• Spain
  • Albacete, Spain, 02006
    • Novartis Investigative Site
  • Badajoz, Spain, 06080
    • Novartis Investigative Site
  • Barcelona, Spain, 08035
    • Novartis Investigative Site
  • Barcelona, Spain, 08036
    • Novartis Investigative Site
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Barcelona, Spain, 08003
    • Novartis Investigative Site
  • Burgos, Spain, 09006
    • Novartis Investigative Site
  • Castellon, Spain, 12002
    • Novartis Investigative Site
  • Don Benito/Badajoz, Spain, 06400
    • Novartis Investigative Site
  • Guadalajara, Spain, 19002
    • Novartis Investigative Site
  • La Coruna, Spain, 15006
    • Novartis Investigative Site
  • La Laguna (Santa Cruz De Tenerife), Spain, 38320
    • Novartis Investigative Site
  • Leon, Spain, 24071
    • Novartis Investigative Site
  • Lleida, Spain, 25198
    • Novartis Investigative Site
  • Lugo, Spain, 27003
    • Novartis Investigative Site
  • Manresa (Barcelona), Spain, 08243
    • Novartis Investigative Site
  • Ourense, Spain, 32005
    • Novartis Investigative Site
  • Pamplona, Spain, 31008
    • Novartis Investigative Site
  • Sabadell (Barcelona), Spain, 08208
    • Novartis Investigative Site
  • Salamanca, Spain, 37007
    • Novartis Investigative Site
  • San Sebastian, Spain, 20014
    • Novartis Investigative Site
  • Santa Cruz de Tenerife, Spain, 38010
    • Novartis Investigative Site
  • Santiago de Compostela, Spain, 15706
    • Novartis Investigative Site
  • Soria, Spain, 42002
    • Novartis Investigative Site
  • Valencia, Spain, 46009
    • Novartis Investigative Site
  • Valladolid, Spain, 47005
    • Novartis Investigative Site
  • Vigo ( Pontevedra), Spain, 36204
    • Novartis Investigative Site
  • Zaragoza, Spain, 50009
    • Novartis Investigative Site
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Novartis Investigative Site
  • Kaohsiung, Taiwan, 813
    • Novartis Investigative Site
  • Taichung, Taiwan, 40402
    • Novartis Investigative Site
  • Taipei, Taiwan
    • Novartis Investigative Site
  • Taipei, Taiwan, 104
    • Novartis Investigative Site
  • Taoyuan Hsien, Taiwan, ROC
    • Novartis Investigative Site
• Turkey
  • Ankara, Turkey, 06500
    • Novartis Investigative Site
  • Ankara, Turkey
    • Novartis Investigative Site
  • Antalya, Turkey, 07059
    • Novartis Investigative Site
  • Antalya, Turkey
    • Novartis Investigative Site
  • Istanbul, Turkey, 34390
    • Novartis Investigative Site
  • Istanbul, Turkey, 34365
    • Novartis Investigative Site
  • Izmir, Turkey
    • Novartis Investigative Site
  • Kayseri, Turkey, 38039
    • Novartis Investigative Site
  • Malatya, Turkey
    • Novartis Investigative Site
  • Samsun, Turkey, 55139
    • Novartis Investigative Site
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Novartis Investigative Site
  • Leicester, United Kingdom, LE1 5WW
    • Novartis Investigative Site
  • Manchester, United Kingdom, M20 4BX
    • Novartis Investigative Site
  • Shrewsbury, United Kingdom, SY3 8XQ
    • Novartis Investigative Site
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • Novartis Investigative Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Novartis Investigative Site
  • California
    • Orange, California, United States, 92868
      • Novartis Investigative Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Novartis Investigative Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Novartis Investigative Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Novartis Investigative Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Novartis Investigative Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Novartis Investigative Site
  • New York
    • Bronx, New York, United States, 10467
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Novartis Investigative Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Novartis Investigative Site
  • Texas
    • Austin, Texas, United States, 78705
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75246
      • Novartis Investigative Site
    • Fort Worth, Texas, United States, 76104
      • Novartis Investigative Site
    • Houston, Texas, United States, 77024
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: Votrient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Evaluate efficacy, safety, RDI, and HRQoL	To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib	Approximately 30 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2012
• Primary Completion (Actual): July 3, 2017
• Study Completion (Actual): July 3, 2017

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 23, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: 115232; CPZP034A2401 (Other Identifier: Novartis)