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    Summary
    EudraCT Number:2017-000619-17
    Sponsor's Protocol Code Number:NAXIVA1.0
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-06-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-000619-17
    A.3Full title of the trial
    Phase II neoadjuvant study of Axitinib for reducing extent of venous tumour thrombus in clear cell renal cell cancer with venous invasion.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see how effective the drug (Axitinib) is at preventing cancer cells from growing and to see if this means that patients with kidney cancer require less extensive surgery.
    A.3.2Name or abbreviated title of the trial where available
    NAXIVA
    A.4.1Sponsor's protocol code numberNAXIVA1.0
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN96273644
    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 SponsorCommon Services Agency (CSA)
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScottish Clinical Trials Research Unit
    B.5.2Functional name of contact pointNiki Couper
    B.5.3 Address:
    B.5.3.1Street AddressGyle Square, 1 South Gyle Crescent
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH12 9EB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312756727
    B.5.5Fax number01312757512
    B.5.6E-mailniki.couper@nhs.net
    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 Inlyta
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameInlyta
    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 INNAxitinib
    D.3.9.1CAS number 319460-85-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAxitinib
    D.3.9.1CAS number 319460-85-0
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Venous tumour thrombus in clear cell renal cell cancer with venous invasion
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10038389
    E.1.2Term Renal cancer
    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 10050018
    E.1.2Term Renal cancer metastatic
    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 research objective is to examine how effective axitinib is at reducing the extent of the cancer invasion into the large blood vessels draining the kidney with a view to reducing the extent of surgery required to then remove the cancerous tissue.
    E.2.2Secondary objectives of the trial
    The secondary research objectives are:
    1. To determine the percentage change in surgical approach (to a less invasive surgical approach) as assessed by review of MRI scans by surgeons at baseline and 9 weeks (i.e after axitinib therapy has been completed).
    2. To determine the percentage change in height of the cancer invasion into the large blood vessels draining the kidney (venous tumour thrombus). This will be evaluated by comparing baseline and week 9 scans. Local Radiologists will conduct the evaluation and a central radiology review will be conducted.
    3. To determine the objective tumour response rate. The patient’s tumours are measured using a standardised method of assessment which determines tumour size and assesses how the patients tumour has responded to trial treatment this is known as Response Rate. The response rate will be measured by MRI/CT scans at baseline and week 9.
    4. To describe complications of surgery (i.e. blood loss and need for a blood transfusion). This will
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18.
    2. Histologically proven clear cell renal cell caricoma.
    3. Immediate resection of the primary tumour considered technically possible.
    4. Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent).
    4. cT3b, cT3c, cT3a (main renal vein).
    5. N0, N1, or Nx.
    6. M0, or M1.
    7. ECOG performance status 0 - 1.
    E.4Principal exclusion criteria
    1. For metastatic (M1) patients: poor risk on Memorial Sloan-Kettering Cancer Centre (MSKCC) score and deemed suitable for cytoreductive nephrectomy at time of enrolment.
    2. The presence of active second malignancy. Patients will be eligible if they have adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, stable prostate cancer or if treated with curative intent for any other cancer with no evidence of disease for 2 years. Patients with prostate cancer will be permitted entry if not receiving treatment and prostate-specific antigen (PSA) is not rising.
    3. Women who are pregnant or are breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy and up to 1 week after treatment. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment.
    4. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after completion of study drug.
    5. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine or pulmonary disease other than directly related to RCC.
    6. Gastrointestinal abnormalities including: a. inability to take oral medication; b. requirement for intravenous alimentation; c. prior surgical procedures affecting absorption including total gastric resection; d. treatment for active peptic ulcer disease in the past 6 months; e. active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; f. malabsorption syndromes.
    7. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors.
    8. Current use, or anticipated need for treatment with, drugs that are known CYP3A4 inducers or substrates for CYP1A2.
    9. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access device or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
    10. Active seizure disorder, spinal cord compression, or carcinomatous meningitis.
    11. Any of the following within 12 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack.
    12. Uncontrolled hypertension (>160/100 mmHg despite optimised antihypertensive treatment).
    13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
    14. ALT or AST ≥ 1.5 x ULN; Bilirubin ≥ 1.5 x ULN.
    15. Serum creatinine ≥ 1.5 x ULN.
    16. Neutrophil count < 1.0 x 109/L; platelet count < 100 x 109/L; Hb ≤ 900g/L.
    17. Known severe hepatic impairment (Child-Pugh class C).
    18. Known hypersensitivity to axitinib or any of its excipients. Specifically patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not enter the study.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of evaluable patients with an improvement in the Mayo classification.

    Mayo Classification
    Level 0: Thrombus limited to the renal vein.
    Level 1: Thrombus into inferior vena cava <2cm from renal vein ostium level.
    Level 2: Inferior vena cava extension >2cm from renal vein ostium and below
    hepatic vein.
    Level 3: Thrombus at the level of or above the hepatic veins but below the
    diaphragm.
    Level 4: Thrombus extending above the diaphragm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Thrombus invasion will be measured using MRI scanning at baseline and at week 9 (pre-surgery) according to the Mayo classification.
    E.5.2Secondary end point(s)
    1. Percentage change in surgical approach.
    2. Percentage change in height of the venous tumour thrombus.
    3. The radiological response rate (RECIST).
    4. Morbidity will be measured using MRI/CT scanning according to the Clavien-Dindo classification.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Percentage change in surgical approach is assessed by review of MRI scans by surgeons at baseline (planned surgical approach) and 9 weeks (actual surgical approach).
    2. Percentage change in height of the venous tumour thrombus will be evaluated by comparing baseline and week 9 scans. Local Radiologists will conduct the evaluation and a central radiology review will be conducted.
    3. The response rate (RECIST) will be measured by MRI/CT at baseline and week 9
    4. Morbidity will be measured using MRI/CT scanning according to the Clavien-Dindo classification at baseline and week 9
    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 Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    The study drug, axitinib, is to be used prior to surgery only. Any further treatment the participant receives will be decided by the local clinician and multi disciplinary team based on standard practice and current drug marketing authorisations as appropriate.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-02
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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