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    Summary
    EudraCT Number:2010-020965-26
    Sponsor's Protocol Code Number:VEG113387
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-020965-26
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of pazopanib as adjuvant therapy for subjects with localized or locally advanced RCC following nephrectomy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test whether pazopanib can prevent or delay kidney tumor coming back after the tumor has been removed
    A.3.2Name or abbreviated title of the trial where available
    VEG113387
    A.4.1Sponsor's protocol code numberVEG113387
    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(0)61 324 1111
    B.5.5Fax number+41(0)613248001
    B.5.6E-mailclinicaltrial.enquiries@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 holderNovartis Europharm 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 (GW786034)
    D.3.2Product code Votrient (GW786034)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.2Current sponsor codeGW786034
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Renal Cell Carcinoma
    E.1.1.1Medical condition in easily understood language
    Renal Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 20.0
    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
    To evaluate disease-free survival (DFS) with pazopanib 600 mg daily initial dose as compared to placebo as adjuvant therapy for subjects with localized/locally advanced RCC following nephrectomy.
    E.2.2Secondary objectives of the trial
    Efficacy objectives: •To evaluate OS and DFS rates at yearly time points (e.g.1 year, 2 years, etc) with pazopanib 600 mg daily initial dose compared to placebo. •To evaluate efficacy endpoints: DFS, OS and DFS rates at yearly time points with pazopanib compared to placebo as adjuvant RCC treatment in all subjects (regardless of whether 600 mg or 800 mg daily initial dose is used). •To evaluate efficacy endpoints DFS and OS with pazopanib 800 mg daily initial dose compared to placebo.
    Safety objective: •To evaluate safety and tolerability in subjects treated with pazopanib 600 mg daily initial dose compare to those treated with placebo. •To evaluate safety and tolerability in subjects treated with pazopanib compared to those treated with placebo in all subjects (regardless of whether 600 mg or 800 mg daily initial dose is used). •To summarize selected safety and tolerability parameters in subjects treated with pazopanib 800 mg daily initial dose compared to those treated with placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent
    2. Diagnosis of RCC with clear-cell or predominant clear-cell histology.
    3. Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on AJCC TNM staging version 2010 and Fuhrman nuclear grading [see Section 12.2 Appendix 2 and Section 12.3 Appendix 3 for details].
    • pT2, G3 or G4, N0; or,
    • pT3, Gany, N0; or,
    • pT4, Gany, N0; or,
    • pTany, Gany, N1
    Note 1: Excisional biopsy is required of all regional lymph node(s) which appear abnormal on pre-operative scans or at surgery.
    In order to properly stratify subjects (see Section 5.5), it is required that the investigator designate the nodal status as either N0 or N1 according to the following criteria which will be captured in the eCRF:
    N0 requires that a subject have no abnormal regional lymph nodes on preoperative scans or visualized at surgery, OR have regional lymph nodes biopsied with negative (no tumor present) result.
    N1 requires that a subject have regional lymph nodes biopsied with positive (tumor present) result.
    Note 2: Subjects with ipsilateral multicentric RCC are eligible if the most advanced lesion per pT stage fulfils any of the aforementioned combinations of pathologic staging and Fuhrman nuclear grading.
    4. Fulfill all of the following criteria of disease-free status at baseline:
    • Had complete gross surgical resection of all RCC via nephrectomy.
    • Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist.
    Note: As noted above, excisional biopsy is required of all regional lymph node(s) which appear abnormal on pre-operative scans or at surgery. In event lymphadenectomy was not performed during surgery, subjects with one or more regional lymph nodes identified with short axis of ≥ 15mm by Independent Central Imaging Review of the baseline scans are considered to have gross residual disease and therefore ineligible. See Section 7.5.3 for Guideline of Imaging Diagnosis for Baseline Disease-free Status.
    5. Received no prior adjuvant or neo-adjuvant treatment for RCC.
    6. Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤ grade 1 per NCI CTCAE (Version 4)
    7. Karnofsky performance scale (KPS) of ≥ 80.
    8. Adequate organ system function as defined in Table 3, page 26 of Protocol 02
    9. Male or female, age ≥ 18 years
    Note 1: Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 7 days of the first dose of study treatment and agree to use an effective contraception method, as described in Section 7.6.7.1, during Study Treatment Period until 14 days following the last dose of study treatment.
    Refer to Section 7.6.7.1 for the definitions of female of childbearing potential and female of non-childbearing potential.
    Note 2: Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and refrain from nursing throughout the study treatment period until 14 days following the last dose of study treatment.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. Locally recurrent RCC, bilateral RCC, or history of another malignancy.
    Exception: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
    2. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
    • Active peptic ulcer disease
    • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation
    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
    3. Active diarrhea of any grade
    4. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
    • Malabsorption syndrome
    • Major resection of the stomach or small bowel resulting in dumping syndrome or clinical signs of malabsorption
    5. History of human immunodeficiency virus (HIV) infection.
    6. History of chronic active hepatitis including subjects who are carriers of hepatitis B virus (HBV) or hepatitis C virus (HCV).
    7. Presence of uncontrolled infection.
    8. History of any one or more of the following cardiovascular conditions within the past 6 months:
    • Cardiac angioplasty or stenting
    • Myocardial infarction
    • Unstable angina
    • Coronary artery bypass graft surgery
    • Symptomatic peripheral arterial vascular disease
    9. History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure [See Section 12.7 Appendix 7 for description]
    10. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
    Note: Subjects with recent DVT who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible
    11. Corrected QT interval (QTc) > 480 milliseconds (msec)
    12. Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg.
    Note: Screening/Baseline blood pressure (BP) must be assessed with three measurements at approximately 2-minute intervals. The mean SBP / DBP values from the three readings must be <140/90 mmHg in order for a subject to be eligible for the study (see Section 7.6.2 for instruction on blood pressure measurement and obtaining mean blood pressure values).
    If the subject’s initial screening SBP/DBP is ≥ 140/90mmHg, initiation or adjustment of antihypertensive medication(s) is permitted in an attempt to control the subject’s BP level to below 140/90mmHg. Once the subject’s BP level is wellcontrolled, BP must be re-assessed with three measurements at approximately 2-minute intervals and the mean SBP/DBP from this reassessment must be <140/90mmHg in order for subject to be eligible. At least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP reassessment. The final reassessed BP values should be entered into eCRF as baseline.
    13. Evidence of active bleeding or bleeding diathesis
    14. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures.
    15. Unable or unwilling to discontinue use of prohibited medications list in Section 6.3 for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment and for the duration of the study.
    16. Concurrent therapy given to treat cancer including treatment with an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug.
    17. Administration of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
    18. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or excipients that in the opinion of the investigator contraindicates their participation.
    19. Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon, interleukin 2).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is DFS, which is defined as time from randomization to developing local disease recurrence and/or metastasis, or death due to any cause whichever comes first
    E.5.1.1Timepoint(s) of evaluation of this end point
    Imaging assessments are the major evaluations for DFS, which will be done at baseline, week 20, 36, 52, every 6 months between year 2-5, then yearly thereafter until study reached the clinical cutoff for DFS.
    E.5.2Secondary end point(s)
    • OS, defined as time from randomization to death due to any cause.
    • DFS rates at yearly time points (e.g. 1 year, 2 years, etc.). Actual time points will depend on data maturity at the time of the DFS analysis
    • The safety endpoints include the incidence, severity and causality of all AE, SAE and other safety parameters during treatment period. Long term safety will also be analyzed.
    • Change from baseline in subject self-reports on health outcome and quality of life as measured by Cancer Therapy-Kidney Symptom Index -19 (FKSI-19) and EuroQOL (EQ-5D), respectively.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Overall survival, defined as the interval from randomization to death due to any cause
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned38
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA167
    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
    E.8.7Trial has a data monitoring committee Yes
    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
    15-April-2019
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days6
    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: 1200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 690
    F.4.2.2In the whole clinical trial 1500
    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)
    Subsequent adjuvant treatments for RCC are not allowed. Once a subject has objective evidence of disease recurrence, he/she should receive the first-line treatment for metastatic RCC per local standard.
    After discontinuation from or completion of the study, subjects can receive further treatment at the discretion of the subjects and their treating physicians.
    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 Decision2010-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-15
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