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Carcinoma, Renal CellPRINCIPALNCT01649778

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

An observational study of Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 144 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Pazopanib
How many people
662 participants
Where
144 sitesin 18 countries
Study dates
19 Jul 2012to 3 Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This observational studies plans to recruit from cliinics that are prescribing pazopanib to patients as part local standard of practice.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

144 sites in 18 countries.

144 sites in 18 countries

Spain28 sites

  • Novartis Investigative Site

    A Coruña, 15006

  • Novartis Investigative Site

    Albacete, 02006

  • Novartis Investigative Site

    Badajoz, 06080

  • Novartis Investigative Site

    Barcelona, 08003

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Burgos, 09006

  • Novartis Investigative Site

    Castellon, 12002

  • Novartis Investigative Site

    Don Benito/Badajoz, 06400

  • Novartis Investigative Site

    Donostia / San Sebastian, 20014

  • Novartis Investigative Site

    Guadalajara, 19002

  • Novartis Investigative Site

    La Laguna (Santa Cruz de Tenerife), 38320

  • Novartis Investigative Site

    León, 24071

  • Novartis Investigative Site

    Lleida, 25198

  • Novartis Investigative Site

    Lugo, 27003

  • Novartis Investigative Site

    Manresa (Barcelona), 08243

  • Novartis Investigative Site

    Ourense, 32005

  • Novartis Investigative Site

    Pamplona, 31008

  • Novartis Investigative Site

    Sabadell (Barcelona), 08208

  • Novartis Investigative Site

    Salamanca, 37007

  • Novartis Investigative Site

    Santa Cruz de Tenerife, 38010

  • Novartis Investigative Site

    Santiago de Compostela, 15706

  • Novartis Investigative Site

    Soria, 42002

  • Novartis Investigative Site

    Valencia, 46009

  • Novartis Investigative Site

    Valladolid, 47005

  • Novartis Investigative Site

    Vigo ( Pontevedra), 36204

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

Germany17 sites

  • Novartis Investigative Site

    Aschaffenburg, Bavaria, 63739

  • Novartis Investigative Site

    Chemnitz, Saxony, 09130

  • Novartis Investigative Site

    Erlangen, Bavaria, 91054

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60431

  • Novartis Investigative Site

    Hof, Bavaria, 95028

  • Novartis Investigative Site

    Homburg, Saarland, 66421

  • Novartis Investigative Site

    Kiel, Schleswig-Holstein, 24105

  • Novartis Investigative Site

    Kirchheim, Baden-Wurttemberg, 73230

  • Novartis Investigative Site

    Landshut, Bavaria, 84028

  • Novartis Investigative Site

    Lehrte, Lower Saxony, 31275

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39104

  • Novartis Investigative Site

    Marburg, Hesse, 35043

  • Novartis Investigative Site

    Markkleeberg, Saxony, 04416

  • Novartis Investigative Site

    Münster, North Rhine-Westphalia, 48149

  • Novartis Investigative Site

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

  • Novartis Investigative Site

    Rostock, Mecklenburg-Vorpommern, 18107

  • Novartis Investigative Site

    Velbert, North Rhine-Westphalia, 42551

Other trials in Germany

United States15 sites

  • Novartis Investigative Site

    Austin, Texas, 78705

  • Novartis Investigative Site

    Charleston, South Carolina, 29414

  • Novartis Investigative Site

    Dallas, Texas, 75246

  • Novartis Investigative Site

    Fort Worth, Texas, 76104

  • Novartis Investigative Site

    Henderson, Nevada, 89052

  • Novartis Investigative Site

    Houston, Texas, 77024

  • Novartis Investigative Site

    Jackson, Mississippi, 39202

  • Novartis Investigative Site

    Jacksonville, Florida, 32256

  • Novartis Investigative Site

    Lincoln, Nebraska, 68510

  • Novartis Investigative Site

    Louisville, Kentucky, 40207

  • Novartis Investigative Site

    Orange, California, 92868

  • Novartis Investigative Site

    Phoenix, Arizona, 85016

  • Novartis Investigative Site

    Shreveport, Louisiana, 71101

  • Novartis Investigative Site

    Sioux Falls, South Dakota, 57105

  • Novartis Investigative Site

    The Bronx, New York, 10467

Other trials in United States

Belgium12 sites

  • Novartis Investigative Site

    Antwerp, 2020

  • Novartis Investigative Site

    Arlon, 6700

  • Novartis Investigative Site

    Bonheiden, 2820

  • Novartis Investigative Site

    Bouge, 5004

  • Novartis Investigative Site

    Brasschaat, 2930

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Haine-Saint-Paul, 7100

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Ostend, 8400

  • Novartis Investigative Site

    Ottignies, 1340

  • Novartis Investigative Site

    Sint-Niklaas, 9100

  • Novartis Investigative Site

    Verviers, 4800

Other trials in Belgium

Turkey (Türkiye)10 sites

  • Novartis Investigative Site

    Ankara, 06500

  • Novartis Investigative Site

    Ankara

  • Novartis Investigative Site

    Antalya, 07059

  • Novartis Investigative Site

    Antalya

  • Novartis Investigative Site

    Istanbul, 34365

  • Novartis Investigative Site

    Istanbul, 34390

  • Novartis Investigative Site

    Izmir

  • Novartis Investigative Site

    Kayseri, 38039

  • Novartis Investigative Site

    Malatya

  • Novartis Investigative Site

    Samsun, 55139

Other trials in Turkey (Türkiye)

Austria9 sites

  • Novartis Investigative Site

    Hall in Tirol, 6060

  • Novartis Investigative Site

    Innsbruck, 6020

  • Novartis Investigative Site

    Leoben, 8700

  • Novartis Investigative Site

    Linz, 4021

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    St.Veit/Glan, 9300

  • Novartis Investigative Site

    Vienna, 1090

  • Novartis Investigative Site

    Vienna, 1220

  • Novartis Investigative Site

    Vöcklabruck, 4840

Other trials in Austria

Hungary9 sites

  • Novartis Investigative Site

    Budapest, 1082

  • Novartis Investigative Site

    Budapest, 1097

  • Novartis Investigative Site

    Budapest, 1122

  • Novartis Investigative Site

    Budapest, 1145

  • Novartis Investigative Site

    Debrecen, H-4032

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Szeged, 6720

  • Novartis Investigative Site

    Szombathely, 9700

  • Novartis Investigative Site

    Veszprém, 8200

Other trials in Hungary

Italy8 sites

  • Novartis Investigative Site

    Cremona, Lombardy, 26100

  • Novartis Investigative Site

    Milan, Lombardy, 20133

  • Novartis Investigative Site

    Modena, Emilia-Romagna, 41100

  • Novartis Investigative Site

    Naples, Campania, 80131

  • Novartis Investigative Site

    Pavia, Lombardy, 27100

  • Novartis Investigative Site

    Rome, Lazio, 00144

  • Novartis Investigative Site

    Rome, Lazio, 00152

  • Novartis Investigative Site

    Rome, Lazio, 00168

Other trials in Italy

Argentina6 sites

  • Novartis Investigative Site

    Berazategui, Buenos Aires, B1880BBF

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5006HBF

  • Novartis Investigative Site

    Córdoba, X5004FHP

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000KZE

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000IAK

  • Novartis Investigative Site

    Santa Fe, 3000

Other trials in Argentina

Taiwan6 sites

  • Novartis Investigative Site

    Kaohsiung City, 807

  • Novartis Investigative Site

    Kaohsiung City, 813

  • Novartis Investigative Site

    Taichung, 40402

  • Novartis Investigative Site

    Taipei, 104

  • Novartis Investigative Site

    Taipei

  • Novartis Investigative Site

    Taoyuan Hsien, ROC

Other trials in Taiwan

Greece5 sites

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Athens, 11522

  • Novartis Investigative Site

    Pátrai, 26504

  • Novartis Investigative Site

    Thessaloniki, 564 29

  • Novartis Investigative Site

    Thessaloniki

Other trials in Greece

Israel5 sites

  • Novartis Investigative Site

    Haifa, 31048

  • Novartis Investigative Site

    Haifa, 31096

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Nahariya, 22100

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

United Kingdom5 sites

  • Novartis Investigative Site

    Birmingham, B9 5SS

  • Novartis Investigative Site

    Leicester, LE1 5WW

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Northwood, Middlesex, HA6 2RN

  • Novartis Investigative Site

    Shrewsbury, SY3 8XQ

Other trials in United Kingdom

Colombia3 sites

  • Novartis Investigative Site

    Bucaramanga

  • Novartis Investigative Site

    Medellín

  • Novartis Investigative Site

    Montería

Other trials in Colombia

Estonia3 sites

  • Novartis Investigative Site

    Tallinn, 10138

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Finland1 site

  • Novartis Investigative Site

    Helsinki, 00029

Other trials in Finland

Lebanon1 site

  • Novartis Investigative Site

    El Achrafiyé, 166484

Other trials in Lebanon

Pakistan1 site

  • Novartis Investigative Site

    Karachi, 74800

Other trials in Pakistan

About this study

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

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).

Read the 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.

Being tested
Pazopanib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Also called Votrient

    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.

Study groups in NCT01649778
Study groupRoleWhat they receive
PazopanibProspective 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.
Receives: Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy

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

    Measured: Approximately 30 months

  2. Relative Dose Intensity(RDI)

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

    Measured: Approximately 30 months

  3. 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

    Measured: Approximately 30 months

  4. 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

    Measured: Approximately 30 months from baseline

  5. 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.

    Measured: From first treatment with pazopanib till 30 days after last dose of pazopanib treatment

Secondary outcomes (2)

  1. 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

    Measured: Approximately 30 months

  2. Evaluate efficacy, safety, RDI, and HRQoL

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

    Measured: Approximately 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2012 (estimated)
  2. Study start19 Jul 2012
  3. Primary completion3 Jul 2017
  4. Study completion3 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
662 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01649778
Sponsor's protocol ID
115232
Other IDs
CPZP034A2401
Acronym
PRINCIPAL
Status last verified
Jul 2020
First submitted
23 Jul 2012
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
No

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.

    PubMed 31196680

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 144 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in Spain, Germany, United States, Belgium, Turkey (Türkiye) and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy (time frame: Approximately 30 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01649778, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.

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