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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01649778
Collaborator
(none)
662
Enrollment
144
Locations
59.5
Actual Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
662 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Actual Study Start Date :
Jul 19, 2012
Actual Primary Completion Date :
Jul 3, 2017
Actual Study Completion Date :
Jul 3, 2017

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy [Approximately 30 months]

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

    2. Relative Dose Intensity(RDI) [Approximately 30 months]

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

    3. Characterise the RCC patient population treated [Approximately 30 months]

      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

    4. Evaluate the change in health-related quality of life (HRQoL) [Approximately 30 months from baseline]

      To evaluate the change in health-related quality of life (HRQoL) relative to baseline in patients treated with pazopanib

    5. Evaluate Safety [From first treatment with pazopanib till 30 days after last dose of pazopanib treatment]

      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.

    Secondary Outcome Measures

    1. Evaluate efficacy and safety comparable to VEG105192 [Approximately 30 months]

      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

    2. Evaluate efficacy, safety, RDI, and HRQoL [Approximately 30 months]

      To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Phoenix Arizona United States 85016
    2 Novartis Investigative Site Orange California United States 92868
    3 Novartis Investigative Site Jacksonville Florida United States 32256
    4 Novartis Investigative Site Louisville Kentucky United States 40207
    5 Novartis Investigative Site Shreveport Louisiana United States 71101
    6 Novartis Investigative Site Jackson Mississippi United States 39202
    7 Novartis Investigative Site Lincoln Nebraska United States 68510
    8 Novartis Investigative Site Henderson Nevada United States 89052
    9 Novartis Investigative Site Bronx New York United States 10467
    10 Novartis Investigative Site Charleston South Carolina United States 29414
    11 Novartis Investigative Site Sioux Falls South Dakota United States 57105
    12 Novartis Investigative Site Austin Texas United States 78705
    13 Novartis Investigative Site Dallas Texas United States 75246
    14 Novartis Investigative Site Fort Worth Texas United States 76104
    15 Novartis Investigative Site Houston Texas United States 77024
    16 Novartis Investigative Site Berazategui Buenos Aires Argentina B1880BBF
    17 Novartis Investigative Site Cordoba Córdova Argentina X5006HBF
    18 Novartis Investigative Site Rosario Santa Fe Argentina S2000KZE
    19 Novartis Investigative Site Cordoba Argentina X5004FHP
    20 Novartis Investigative Site San Miguel de Tucuman Argentina T4000IAK
    21 Novartis Investigative Site Santa Fe Argentina 3000
    22 Novartis Investigative Site Hall in Tirol Austria 6060
    23 Novartis Investigative Site Innsbruck Austria 6020
    24 Novartis Investigative Site Leoben Austria 8700
    25 Novartis Investigative Site Linz Austria 4021
    26 Novartis Investigative Site Salzburg Austria 5020
    27 Novartis Investigative Site St.Veit/Glan Austria 9300
    28 Novartis Investigative Site Voecklabruck Austria 4840
    29 Novartis Investigative Site Wien Austria 1090
    30 Novartis Investigative Site Wien Austria 1220
    31 Novartis Investigative Site Antwerpen Belgium 2020
    32 Novartis Investigative Site Arlon Belgium 6700
    33 Novartis Investigative Site Bonheiden Belgium 2820
    34 Novartis Investigative Site Bouge Belgium 5004
    35 Novartis Investigative Site Brasschaat Belgium 2930
    36 Novartis Investigative Site Edegem Belgium 2650
    37 Novartis Investigative Site Haine Saint Paul Belgium 7100
    38 Novartis Investigative Site Liege Belgium 4000
    39 Novartis Investigative Site Oostende Belgium 8400
    40 Novartis Investigative Site Ottignies Belgium 1340
    41 Novartis Investigative Site Sint-Niklaas Belgium 9100
    42 Novartis Investigative Site Verviers Belgium 4800
    43 Novartis Investigative Site Bucaramanga Colombia
    44 Novartis Investigative Site Medellin Colombia
    45 Novartis Investigative Site Monteria Colombia
    46 Novartis Investigative Site Tallinn Estonia 10138
    47 Novartis Investigative Site Tallinn Estonia 13419
    48 Novartis Investigative Site Tartu Estonia 51014
    49 Novartis Investigative Site Helsinki Finland 00029
    50 Novartis Investigative Site Kirchheim Baden-Wuerttemberg Germany 73230
    51 Novartis Investigative Site Aschaffenburg Bayern Germany 63739
    52 Novartis Investigative Site Erlangen Bayern Germany 91054
    53 Novartis Investigative Site Hof Bayern Germany 95028
    54 Novartis Investigative Site Landshut Bayern Germany 84028
    55 Novartis Investigative Site Frankfurt Hessen Germany 60431
    56 Novartis Investigative Site Marburg Hessen Germany 35043
    57 Novartis Investigative Site Neubrandenburg Mecklenburg-Vorpommern Germany 17036
    58 Novartis Investigative Site Rostock Mecklenburg-Vorpommern Germany 18107
    59 Novartis Investigative Site Lehrte Niedersachsen Germany 31275
    60 Novartis Investigative Site Muenster Nordrhein-Westfalen Germany 48149
    61 Novartis Investigative Site Velbert Nordrhein-Westfalen Germany 42551
    62 Novartis Investigative Site Homburg Saarland Germany 66421
    63 Novartis Investigative Site Magdeburg Sachsen-Anhalt Germany 39104
    64 Novartis Investigative Site Chemnitz Sachsen Germany 09130
    65 Novartis Investigative Site Markkleeberg Sachsen Germany 04416
    66 Novartis Investigative Site Kiel Schleswig-Holstein Germany 24105
    67 Novartis Investigative Site Athens Greece 115 28
    68 Novartis Investigative Site Athens Greece 11522
    69 Novartis Investigative Site Patra Greece 26504
    70 Novartis Investigative Site Thessaloniki Greece 564 29
    71 Novartis Investigative Site Thessaloniki Greece
    72 Novartis Investigative Site Budapest Hungary 1082
    73 Novartis Investigative Site Budapest Hungary 1097
    74 Novartis Investigative Site Budapest Hungary 1122
    75 Novartis Investigative Site Budapest Hungary 1145
    76 Novartis Investigative Site Debrecen Hungary H-4032
    77 Novartis Investigative Site Pecs Hungary 7624
    78 Novartis Investigative Site Szeged Hungary 6720
    79 Novartis Investigative Site Szombathely Hungary 9700
    80 Novartis Investigative Site Veszprem Hungary 8200
    81 Novartis Investigative Site Haifa Israel 31048
    82 Novartis Investigative Site Haifa Israel 31096
    83 Novartis Investigative Site Jerusalem Israel 91120
    84 Novartis Investigative Site Nahariya Israel 22100
    85 Novartis Investigative Site Tel Aviv Israel 64239
    86 Novartis Investigative Site Napoli Campania Italy 80131
    87 Novartis Investigative Site Modena Emilia-Romagna Italy 41100
    88 Novartis Investigative Site Roma Lazio Italy 00144
    89 Novartis Investigative Site Roma Lazio Italy 00152
    90 Novartis Investigative Site Roma Lazio Italy 00168
    91 Novartis Investigative Site Cremona Lombardia Italy 26100
    92 Novartis Investigative Site Milano Lombardia Italy 20133
    93 Novartis Investigative Site Pavia Lombardia Italy 27100
    94 Novartis Investigative Site Ashrafieh Lebanon 166484
    95 Novartis Investigative Site Karachi Pakistan 74800
    96 Novartis Investigative Site Albacete Spain 02006
    97 Novartis Investigative Site Badajoz Spain 06080
    98 Novartis Investigative Site Barcelona Spain 08003
    99 Novartis Investigative Site Barcelona Spain 08035
    100 Novartis Investigative Site Barcelona Spain 08036
    101 Novartis Investigative Site Barcelona Spain 08041
    102 Novartis Investigative Site Burgos Spain 09006
    103 Novartis Investigative Site Castellon Spain 12002
    104 Novartis Investigative Site Don Benito/Badajoz Spain 06400
    105 Novartis Investigative Site Guadalajara Spain 19002
    106 Novartis Investigative Site La Coruna Spain 15006
    107 Novartis Investigative Site La Laguna (Santa Cruz De Tenerife) Spain 38320
    108 Novartis Investigative Site Leon Spain 24071
    109 Novartis Investigative Site Lleida Spain 25198
    110 Novartis Investigative Site Lugo Spain 27003
    111 Novartis Investigative Site Manresa (Barcelona) Spain 08243
    112 Novartis Investigative Site Ourense Spain 32005
    113 Novartis Investigative Site Pamplona Spain 31008
    114 Novartis Investigative Site Sabadell (Barcelona) Spain 08208
    115 Novartis Investigative Site Salamanca Spain 37007
    116 Novartis Investigative Site San Sebastian Spain 20014
    117 Novartis Investigative Site Santa Cruz de Tenerife Spain 38010
    118 Novartis Investigative Site Santiago de Compostela Spain 15706
    119 Novartis Investigative Site Soria Spain 42002
    120 Novartis Investigative Site Valencia Spain 46009
    121 Novartis Investigative Site Valladolid Spain 47005
    122 Novartis Investigative Site Vigo ( Pontevedra) Spain 36204
    123 Novartis Investigative Site Zaragoza Spain 50009
    124 Novartis Investigative Site Kaohsiung Taiwan 807
    125 Novartis Investigative Site Kaohsiung Taiwan 813
    126 Novartis Investigative Site Taichung Taiwan 40402
    127 Novartis Investigative Site Taipei Taiwan 104
    128 Novartis Investigative Site Taipei Taiwan
    129 Novartis Investigative Site Taoyuan Hsien Taiwan ROC
    130 Novartis Investigative Site Ankara Turkey 06500
    131 Novartis Investigative Site Ankara Turkey
    132 Novartis Investigative Site Antalya Turkey 07059
    133 Novartis Investigative Site Antalya Turkey
    134 Novartis Investigative Site Istanbul Turkey 34365
    135 Novartis Investigative Site Istanbul Turkey 34390
    136 Novartis Investigative Site Izmir Turkey
    137 Novartis Investigative Site Kayseri Turkey 38039
    138 Novartis Investigative Site Malatya Turkey
    139 Novartis Investigative Site Samsun Turkey 55139
    140 Novartis Investigative Site Northwood Middlesex United Kingdom HA6 2RN
    141 Novartis Investigative Site Birmingham United Kingdom B9 5SS
    142 Novartis Investigative Site Leicester United Kingdom LE1 5WW
    143 Novartis Investigative Site Manchester United Kingdom M20 4BX
    144 Novartis Investigative Site Shrewsbury United Kingdom SY3 8XQ

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01649778
    Other Study ID Numbers:
    • 115232
    • CPZP034A2401
    First Posted:
    Jul 25, 2012
    Last Update Posted:
    Jul 15, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Jul 15, 2020