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    Summary
    EudraCT Number:2011-004562-16
    Sponsor's Protocol Code Number:ICR-CTSU/2011/10033
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-09
    Trial 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 number2011-004562-16
    A.3Full title of the trial
    A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer Unsuitable for Nephrectomy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Axitinib Treatment for Widespread Kidney Cancer Unsuitable for Surgery
    A.3.2Name or abbreviated title of the trial where available
    A-PREDICT
    A.4.1Sponsor's protocol code numberICR-CTSU/2011/10033
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN72679844
    A.5.4Other Identifiers
    Name:Sponsor Identification NumberNumber:CCR3587
    Name:ICR-CTSU Protocol NumberNumber:ICR-CTSU/2011/10033
    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 SponsorInstitute of Cancer Research
    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 Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Institute of Cancer Research
    B.5.2Functional name of contact pointRachel Todd
    B.5.3 Address:
    B.5.3.1Street AddressICR Clinical Trials & Statistics Unit (ICR-CTSU)
    B.5.3.2Town/ cityThe Institute of Cancer Research
    B.5.3.3Post codeSM2 5NG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02087224315
    B.5.5Fax number0208 770 7876
    B.5.6E-mailapredict-icrctsu@icr.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorThe Royal Marsden Hospital NHS Foundation Trust
    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 supportSee above
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Institute of Cancer Research
    B.5.2Functional name of contact pointRachel Todd
    B.5.3 Address:
    B.5.3.1Street AddressICR-CTSU, 15 Cotswold Road
    B.5.3.2Town/ citySutton, Surrey
    B.5.3.3Post codeSM2 5NG
    B.5.4Telephone number02087224315
    B.5.5Fax number0208 770 7876
    B.5.6E-mailapredict-icrctsu@icr.ac.uk
    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 No
    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 nameAxitinib
    D.3.2Product code AG-013736
    D.3.4Pharmaceutical form 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 to 5
    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
    Metastatic renal cell carcinoma
    E.1.1.1Medical condition in easily understood language
    Widespread 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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10050076
    E.1.2Term Metastatic renal carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does treatment with axitinib stop previously untreated widespread kidney cancer that can't be surgically removed from getting worse for at least 6 months?
    E.2.2Secondary objectives of the trial
    SECONDARY RESEARCH QUESTIONS:
    What is the largest reduction in a participant's cancer seen during treatment with axitinib?

    How long does treatment with axitinib stop participants' cancer from getting worse?

    How long does treatment with axitinib keep people alive?

    What are the side effects of treatment with axitinib in this group of patients?

    How many participants' will be able to have surgery to remove their kidney due to treatment with axitinib?

    EXPLORATORY QUESTION:
    Are there biological or genetic markers that could be used to indicate who will respond best to axitinib treatment in future?
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A-PREDICT Translational Study
    A key aim of this study is to evaluate changes in circulating and tumour biomarkers in relation to tumour response.
    E.3Principal inclusion criteria
    1. Histologically confirmed metastatic renal cell carcinoma of predominant clear cell histology
    2. Unsuitable for nephrectomy as judged by treating clinician(s)
    3. Not suitable for ‘watch and wait’ policy as determined by treating clinician(s)
    4. No prior systemic therapy for renal cell carcinoma
    5. Measurable metastatic disease using RECIST v1.1 (see Appendix A)
    6. 18 years of age or older
    7. Life expectancy of 12 weeks or greater
    8. ECOG performance status 0 or 1
    9. Adequate organ function as defined by serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are due to liver metastases; total serum bilirubin ≤1.5 x ULN
    10. Adequate haematological function as defined by absolute neutrophil count (ANC) ≥1500/µL, platelets ≥75,000/µL, haemoglobin ≥9.0 g/dL and prothrombin time (PT) ≤1.5 x ULN
    11. Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min;
    12. Urinary protein <2+ by urine dipstick. If dipstick is ≥2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2g per 24 hours.
    13. No evidence of pre-existing uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ≤140 mm Hg, and the baseline diastolic blood pressure readings must be ≤90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
    14. Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.
    15. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including tumour biopsies.
    16. Written informed consent
    E.4Principal exclusion criteria
    1. The presence of intracranial disease, unless there has been radiological evidence of stable intracranial disease >6 months. In the case of a solitary brain metastasis which has been resected, there must be evidence of a disease-free interval of at least 3 months post-surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days.
    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.
    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. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment.
    4. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy.
    5. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine, 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 (see section 8.12, concomitant therapy).
    8. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (see section 8.12, concomitant therapy).
    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. Deep vein thrombosis or pulmonary embolism within 6 months prior to study entry.
    13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
    14. Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients treated with axitinib who are free from disease progression 6 months from the commencement of treatment. Progression will be measured from the date of study entry (registration date) until the first date of either death or confirmed progressive disease according to Response Evaluation Criteria In Solid Tumors (RECIST)v1.1. The main timepoint of interest is 6 months after study entry.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months from start of treatment.
    E.5.2Secondary end point(s)
    • Best overall response confirmed according to RECIST v1.1.
    • Progression free survival confirmed according to RECIST v1.1.
    • Overall survival
    • Safety and toxicity of axitinib (by NCI CTC grading version 4).
    • Number of patients who become suitable for nephrectomy as a consequence of therapy with axitinib.

    All secondary endpoints will be measured from time of registration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Best overall response - during or within 30 days after termination of axitinib
    Progression-free survival - first date of either death or confirmed progressive disease - time to last follow-up will be used if patient has not progressed or died and PFS time for the patient will be considered censored.
    Overall survival will be measured until the date of death due to any cause - time to last follow-up will be used if patient has not died and survival time for the patient will be considered censored.
    Safety and toxicity will be assessed throughout the treatment period.
    Number of patients suitable for nephrectomy will be assessed at time of last follow up.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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.6.13.1Other scope of the trial description
    Evaluation of changes in biomarkers in response to treatment
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned12
    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
    The study end date is deemed to be the date of last data capture.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days29
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state99
    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)
    Participants will continue to receive axitinib until they are no longer receiving any benefit from treatment. Participants' continued care following discontinuation of axitinib will be at the discretion of their clinical care team and will be decided in consultation with the participant.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-08
    P. End of Trial
    P.End of Trial StatusOngoing
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