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    Summary
    EudraCT Number:2011-003065-15
    Sponsor's Protocol Code Number:VEG115232
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-02-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2011-003065-15
    A.3Full title of the trial
    PRINCIPAL: A Prospective Observational Study of Real World Treatment Patterns and Treatment Outcomes in Patients with Advanced or Metastatic Renal Cell Carcinoma Receiving Pazopanib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to observe the effects of treating patients with pazopanib in the real world setting.
    A.3.2Name or abbreviated title of the trial where available
    PRINCIPAL
    A.4.1Sponsor's protocol code numberVEG115232
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma Services AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1 Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 61 324 1111
    B.5.5Fax number+41 61 324 8001
    B.5.6E-mailclinicaltrial.enquiries@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Votrient
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVotrient
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    advanced or metastatic Renal Cell Carcinoma
    E.1.1.1Medical condition in easily understood language
    Kidney Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10038415
    E.1.2Term Renal cell carcinoma stage unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10067946
    E.1.2Term Renal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the PRINCIPAL study are:
    1. To evaluate overall survival (OS), progression-free survival (PFS) and the overall response rate (ORR) in patients treated with pazopanib;
    2. To characterise the relative dose intensity (RDI) and its observed effect on treatment outcomes;
    3. 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. To evaluate the change in health-related quality of life (HRQoL) relative to baseline
    in patients treated with pazopanib; and
    5. To evaluate the frequency of serious adverse events (SAEs) and adverse events of
    special interest (AESIs) in patients treated with pazopanib.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the PRINCIPAL study are:
    1. To evaluate clinical effectiveness, safety and RDI in those patients treated with pazopanib with comparable baseline characteristics to those included in the Phase III
    clinical trial [VEG105192];
    2. To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    Specific information regarding warnings, precautions, contraindications, adverse events,
    and other pertinent information regarding pazopanib that may impact patient treatment is
    found in the local product labeling.
    Deviations from inclusion criteria are not allowed because they can potentially jeopardize
    the scientific integrity of the study. Therefore, adherence to the criteria as specified in the
    protocol is essential.
    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
    E.4Principal exclusion criteria
    Exclusion Criteria
    Deviations from exclusion criteria are not allowed because they can potentially
    jeopardize the scientific integrity of the study. Therefore, adherence to the criteria as
    specified in the protocol is essential.
    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 (for guidance, refer
    to Appendix 1 located in the protocol).
    • Life expectancy < 12 weeks
    E.5 End points
    E.5.1Primary end point(s)
    1-PFS: defined as the interval between the date of first treatment with pazopanib and the earliest date of disease progression (by tumour response
    assessed by imaging or by clinical deterioration,
    whichever comes first) or death due to any cause OS: defined as the time from first treatment with
    pazopanib until death due to any cause
    ORR: defined as the percentage of patients with documented response (CR or PR) at any time during follow-up.
    2-Study population distribution of RDI.
    3-Study population distribution of baseline
    characteristics.
    4-Change from baseline.
    5-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
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over approximately 30 months:
    Evaluate overall and progression-free survival and overall response rate

    Relative Dose Intensity (RDI): Characterize RDI and its observed effect on treatment outcomes

    Characterise RCC patient population: Characterise study patient population in comparison to a clinical trial population

    Evaluate change in health-related quality of life (HRQoL): Evaluate change in HRQoL from baseline

    Evaluate Safety [From first dose of pazopanib until 30 days after last dose]: Evaluate frequency of serious adverse events (SAEs) and adverse events of special interest (AESIs) Endpoint: Any event that results in dose modification or discontinuation [Evidence of liver toxicity, cardiac dysfunction, thyroid dysfunction, onset or worsened hypertension]
    E.5.2Secondary end point(s)
    Secondary Outcome Measures:
    •Evaluate efficacy and safety comparable to VEG105192 [ Time Frame: 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


    •Evaluate efficacy, safety, RDI, and HRQoL [ Time Frame: Approximately 30 months ]
    To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Outcome Measures:
    •Evaluate efficacy and safety comparable to VEG105192 [ Time Frame: 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


    •Evaluate efficacy, safety, RDI, and HRQoL [ Time Frame: Approximately 30 months ]
    To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Observational study - real world treatment patterns and treatment outcomes in patients with advanced metastatic renal cell carcinoma recieving Pazopanib
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Canada
    Colombia
    Pakistan
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    When all enrolled patients either (1) die during the
    study treatment (2) or during follow-up period (3) or has been in follow-up for 30 months, whichever is sooner (4) Withdrawal of consent (5) Lost to follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 700
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None (no plans within the protocol). However subjects may move onto other treatments as per local standard of care under the supervision of the healthcare provider.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-03
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